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Life
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COVID-19 Prevention and Treatment
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COVID-19 Prevention and Treatment

A special issue of Life (ISSN 2075-1729). This special issue belongs to the section "Epidemiology".

Deadline for manuscript submissions: closed (21 November 2022) | Viewed by 65571

Special Issue Editors

Dr. Silvia De Francia

E-Mail Website
Guest Editor
Department of Biological and Clinical Sciences, University of Turin, S. Luigi Gonzaga Hospital, 10043 Orbassano, Italy
Interests: pharmacology; sex and gender medicine; pharmacokinetics; pharmacodynamics; pharmacogenomics; personalized therapy
Special Issues, Collections and Topics in MDPI journals
Dr. Sarah Allegra

E-Mail Website
Guest Editor
Department of Biological and Clinical Sciences, University of Turin, S. Luigi Gonzaga Hospital, 10043 Orbassano, Italy
Interests: sex and gender pharmacology; gender medicine; pharmacokinetics; pharmacogenomics; personalized therapy.
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

What started as a cluster of patients with a mysterious respiratory illness in December 2019 was later identified as COVID-19. The pathogen of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a novel Betacoronavirus, was subsequently isolated as the causative disease agent. Within a few months, the world experienced a pandemic. However, we have viewed the cause of this crisis only as an infectious disease. All of our interventions have focused on cutting lines of viral transmission, thereby controlling the spread of the pathogen. The science approach that has guided governments has been driven mostly by epidemic modelers and infectious disease specialists, who understandably frame the present health emergency in centuries-old terms of the plague. However, what we have learned thus far tells us that the story of COVID-19 is not so simple. COVID-19 is not a pandemic: it is a syndemic. The syndemic nature of the threat we face means that a wider approach is needed if we really want to protect the health of our communities. This Special Issue arises from the need for a new approach both in the clinical setting and in therapeutic regimens, sharing results from clinical and preclinical studies, in order to enlighten some aspects of the difficult story of COVID-19.

Original research articles, reviews, and short reports on various aspects of COVID-19 are welcome, in order to create an interdisciplinary consensus in a new perspective.

Dr. Silvia De Francia
Dr. Sarah Allegra
Guest Editors

Manuscript Submission Information

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Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Life is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • COVID-19
  • therapies
  • drug repurposing
  • tailored treatment
  • personalized medicine

Published Papers (22 papers)

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Editorial

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5 pages, 209 KiB  
Editorial
COVID-19 Prevention and Treatment
by Silvia De Francia, Francesco Chiara and Sarah Allegra
Life 2023, 13(3), 834; https://0-doi-org.brum.beds.ac.uk/10.3390/life13030834 - 20 Mar 2023
Cited by 1 | Viewed by 1832
Abstract
Coronavirus disease 2019 (COVID-19) has spread and become a substantial public health concern worldwide [...] Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)

Research

Jump to: Editorial, Review, Other

12 pages, 644 KiB  
Article
Inflammation as Prognostic Hallmark of Clinical Outcome in Patients with SARS-CoV-2 Infection
by Diana Fuzio, Angelo Michele Inchingolo, Vitalba Ruggieri, Massimo Fasano, Maria Federico, Manuela Mandorino, Lavinia Dirienzo, Salvatore Scacco, Alessandro Rizzello, Maurizio Delvecchio, Massimiliano Parise, Roberto Rana, Nicola Faccilongo, Biagio Rapone, Francesco Inchingolo, Antonio Mancini, Maria Celeste Fatone, Antonio Gnoni, Gianna Dipalma and Giovanni Dirienzo
Life 2023, 13(2), 322; https://0-doi-org.brum.beds.ac.uk/10.3390/life13020322 - 23 Jan 2023
Cited by 4 | Viewed by 1707
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is often characterized by a life-threatening interstitial pneumonia requiring hospitalization. The aim of this retrospective cohort study is to identify hallmarks of in-hospital mortality in patients affected by Coronavirus Disease 19 (COVID-19). A total of 150 [...] Read more.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is often characterized by a life-threatening interstitial pneumonia requiring hospitalization. The aim of this retrospective cohort study is to identify hallmarks of in-hospital mortality in patients affected by Coronavirus Disease 19 (COVID-19). A total of 150 patients admitted for COVID-19 from March to June 2021 to “F. Perinei” Murgia Hospital in Altamura, Italy, were divided into survivors (n = 100) and non-survivors groups (n = 50). Blood counts, inflammation-related biomarkers and lymphocyte subsets were analyzed into two groups in the first 24 h after admission and compared by Student’s t-test. A multivariable logistic analysis was performed to identify independent risk factors associated with in-hospital mortality. Total lymphocyte count and CD3+ and CD4+ CD8+ T lymphocyte subsets were significantly lower in non-survivors. Serum levels of interleukin-6 (IL-6), lactate dehydrogenase (LDH), C-reactive protein (CRP) and procalcitonin (PCT) were significantly higher in non-survivors. Age > 65 years and presence of comorbidities were identified as independent risk factors associated with in-hospital mortality, while IL-6 and LDH showed a borderline significance. According to our results, markers of inflammation and lymphocytopenia predict in-hospital mortality in COVID-19. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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13 pages, 666 KiB  
Article
Convalescent Plasma to Treat COVID-19: A Two-Center, Randomized, Double-Blind Clinical Trial
by Yanet Ventura-Enríquez, Carlos Cabello-Gutiérrez, Ángel Augusto Pérez-Calatayud, Evelyn Cortina-De la Rosa, Christian Javier Fareli-González, Paola Castillo-Juárez, Alberto Peña-Pérez Carlos, Elí Omar Zavaleta-Martínez, Elizabeth Diaz-Padilla, Sandra Murrieta, Violeta Deyanira Álvarez-Jiménez, Juan Alberto Díaz Ponce-Medrano, Catalina Casillas-Suárez, María Angelica Ocampo-Ocampo, Cruz Vargas-De-León and Verónica Fernández-Sánchez
Life 2022, 12(11), 1767; https://0-doi-org.brum.beds.ac.uk/10.3390/life12111767 - 02 Nov 2022
Cited by 2 | Viewed by 1624
Abstract
Background: The use of convalescent plasma (CP) has been considered for its immunological mechanisms that could benefit patients in moderate and severe stages of COVID-19. This study evaluated the safety and efficacy of the use of donor CP for COVID-19. Material and methods: [...] Read more.
Background: The use of convalescent plasma (CP) has been considered for its immunological mechanisms that could benefit patients in moderate and severe stages of COVID-19. This study evaluated the safety and efficacy of the use of donor CP for COVID-19. Material and methods: A double-blind, randomized controlled clinical trial was conducted from May to October 2020. Thirty-nine participants with moderate (II) and severe (III) stages of COVID-19 confirmed by RT-PCR were included. The study randomization rate was set at 3:1. CPs were chosen for application with a neutralizing antibody titer of ≥1:32. Results: We observed a significantly lower 21-day post-transfusion mortality HR: 0.17 (95.0% CI [0.07–0.45, p < 0.001]) in the group receiving CP compared with the control group; protective units (PU) in the group receiving convalescent plasma after seven days were significantly higher (512 (32–16,384) vs. 96 (32–256), p = 0.01); the PAO2/FIO2 index showed a significant improvement in the group receiving CP (251.01 (109.4) vs. 109.2 (62.4), p < 0.001, in the control group). Conclusion: CP is safe and effective, as it decreased mortality in the CP group compared with the control group. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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12 pages, 265 KiB  
Article
The Rescue of the Romanian Health System by the Emergency Departments during the Fourth Wave of COVID-19 Pandemic
by Bogdan Oprita, Andrei Davidoiu, Alexandru Bogdan Dinu and Ruxandra Oprita
Life 2022, 12(10), 1547; https://0-doi-org.brum.beds.ac.uk/10.3390/life12101547 - 06 Oct 2022
Cited by 2 | Viewed by 1667
Abstract
The COVID-19 pandemic has led to the confrontation of the health system with the need to identify solutions for providing medical care to a very large number of patients. The main objective of our study was to describe the measures taken to provide [...] Read more.
The COVID-19 pandemic has led to the confrontation of the health system with the need to identify solutions for providing medical care to a very large number of patients. The main objective of our study was to describe the measures taken to provide optimal medical care to patients who presented themselves in one of the large emergency hospitals of Romania in the fourth wave of the COVID-19 pandemic. Material and Methods: We conducted a retrospective, observational study on a group of 1417 patients. The statistical analysis was performed using R. Results: The average length of stay of patients in the emergency departments was approximately 2.6 h, increasing to up to 15 days in some more severe cases. For rapid antigen tests, the highest positivity rate for SARS-CoV-2 was identified in patients aged >75 years (53%). Among the identified risk factors associated with the need for mechanical ventilation were advanced age (α < 0.001) and lack of vaccination against SARS-CoV-2 (α < 0.001). Discussion and conclusions: A method of saving the Romanian health system in full hospital bed occupancy conditions in the wards proved to be the provision of medical care in emergency departments. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
10 pages, 1196 KiB  
Article
Renessans Helps in Early Clearance of SARS-CoV-2: In-Vivo Activity of the Iodine Complex in Rhesus macaque
by Muhammad Nawaz, Muhammad Adnan Ashraf, Muhammad Asad Ali, Muhammad Zubair Shabbir, Muhammad Abu Bakr Shabbir, Imran Altaf, Sohail Raza, Saira Rafique, Sohail Hassan, Nageen Sardar, Adnan Mehmood, Muhammad Waqar Aziz, Sehar Fazal, Muhammad Tahir Khan, Hafiz Muhammad Moavia Atique, Ali Asif, Zia Ullah, Mubashir Iqbal, Talha Imtiaz, Muhammad Anwar, Nadia Mukhtar and Tahir Yaqubadd Show full author list remove Hide full author list
Life 2022, 12(9), 1424; https://0-doi-org.brum.beds.ac.uk/10.3390/life12091424 - 13 Sep 2022
Cited by 1 | Viewed by 1915
Abstract
Iodine complexes have known antimicrobial properties along with reported in-vitro antiviral activity for several viruses. Renessans is one such product with iodine complexes and ascorbic acid. The present study was designed to determine its efficacy for SARS-CoV-2 in Rhesus macaque. Rhesus macaque [...] Read more.
Iodine complexes have known antimicrobial properties along with reported in-vitro antiviral activity for several viruses. Renessans is one such product with iodine complexes and ascorbic acid. The present study was designed to determine its efficacy for SARS-CoV-2 in Rhesus macaque. Rhesus macaque were assigned to: A) prophylactic group (n = 3), (B) treatment group (n = 3), (C) infection control group (n = 4), and (D) negative control group (n = 4). Groups A, B, and C were challenged with 2 × 106 TCID of SARS-CoV-2. The prophylactic group (A) was administered Renessans from 5 days before infection till 8 days postinfection (DPI). The treatment group (B) was administered Renessans from 3 till 8 DPI. Group C was administered water-insoluble fractions only. Nasal swabs from all monkeys of groups A, B, and C remained positive for SARS-CoV-2 till 2 and 7 DPI, while the swabs became negative for groups A and B at 14 DPI. Likewise, fecal matter of monkeys in group A returned negative results during the experiment, while that of group B had significantly decreased viral load (101.5 genome copies/mL) compared to group C (103 genome copies/mL). Hence, it is concluded that Renessans has in-vivo SARS-CoV-2 activity and may result in early clearance of SARS-CoV-2. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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17 pages, 2927 KiB  
Article
Effectiveness of the Inactivated SARS-CoV-2 (Vero Cell) Vaccine in Peruvian Health Workers
by Maria Edith Solis-Castro, Alex Jaramillo-Corrales, Rommell Veintimilla Gonzalez Seminario, Noemi Janampa Grados, Idania Edith Mamani Pilco, Karina Elizabeth Vargas Quispe, Lenin Yonel La Torre Rosillo, Mario Neyser Vásquez Dominguez, David Teodoro Enriquez Cusi, Percy Minaya, Karim Jacqueline Pardo Ruiz, Cristian Díaz-Vélez, Vannesa A. Pachas, Ricardo Wesley Alberca and Paul E. Pachas
Life 2022, 12(9), 1318; https://0-doi-org.brum.beds.ac.uk/10.3390/life12091318 - 26 Aug 2022
Cited by 6 | Viewed by 6493
Abstract
Introduction: The COVID-19 pandemic has caused a global health crisis. Vaccines against this disease have demonstrated variable efficacy and safety, although effectiveness has not been evaluated. In February 2021, the Ministry of Health of Peru approved the emergency use of the inactivated SARS-CoV-2 [...] Read more.
Introduction: The COVID-19 pandemic has caused a global health crisis. Vaccines against this disease have demonstrated variable efficacy and safety, although effectiveness has not been evaluated. In February 2021, the Ministry of Health of Peru approved the emergency use of the inactivated SARS-CoV-2 (Vero Cell) vaccine and initiated vaccination with health personnel at the national level. The objective of the study is to determine the effectiveness of this vaccine to reduce infections, hospitalizations, and deaths due to COVID-19. Methodology: We performed a retrospective cohort study in the period from 23 February to 26 June 2021; data were obtained from the Ministry of Health (including demographic, epidemiologic, clinical, hospital, laboratory results, deaths, and both date and quantity of vaccine doses delivered). The exposed cohort were those who received one or two vaccine doses and the non-exposed were unvaccinated. The events studied were infections, hospitalizations and deaths in the cohorts. We consider a case confirmed for COVID-19 if the test result was positive for SARS-CoV-2, via PCR or antigen test. Effectiveness was measured with incidence density ratio and risk. Confounding factors were controlled using a Poisson model with robust variance. Results: We enlisted 520,733 health workers, of whom 415,212 had two vaccine doses and 105,521 were unvaccinated. The median age was 40 years (IQR: 32–50), and 65.6% were female. The effectiveness of two vaccine doses fourteen days after application adjusted by age, sex, hospitalization, and antecedent of having the infection was 90.9% (95% CI: 85.5–94.2%); effectiveness to avoid death from COVID-19; 67.7% (60.1–73.8%) effectiveness to avoid hospitalizations; and 26.3% (23.8–28.6%) effectiveness to reduce the risk of infection by SARS-CoV-2 relative to the unvaccinated cohort. Conclusions: The inactivated SARS-CoV-2 (Vero Cell) vaccine used in two doses has an acceptable effectiveness against death and risk of hospitalization, whereas it has less effectiveness in preventing COVID-19 infection. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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18 pages, 2600 KiB  
Article
Exome-Wide Association Study Reveals Host Genetic Variants Likely Associated with the Severity of COVID-19 in Patients of European Ancestry
by Priyanka Upadhyai, Pooja U. Shenoy, Bhavya Banjan, Mohammed F. Albeshr, Shahid Mahboob, Irfan Manzoor and Ranajit Das
Life 2022, 12(9), 1300; https://0-doi-org.brum.beds.ac.uk/10.3390/life12091300 - 24 Aug 2022
Cited by 4 | Viewed by 2656
Abstract
Host genetic variability plays a pivotal role in modulating COVID-19 clinical outcomes. Despite the functional relevance of protein-coding regions, rare variants located here are less likely to completely explain the considerable numbers of acutely affected COVID-19 patients worldwide. Using an exome-wide association approach, [...] Read more.
Host genetic variability plays a pivotal role in modulating COVID-19 clinical outcomes. Despite the functional relevance of protein-coding regions, rare variants located here are less likely to completely explain the considerable numbers of acutely affected COVID-19 patients worldwide. Using an exome-wide association approach, with individuals of European descent, we sought to identify common coding variants linked with variation in COVID-19 severity. Herein, cohort 1 compared non-hospitalized (controls) and hospitalized (cases) individuals, and in cohort 2, hospitalized subjects requiring respiratory support (cases) were compared to those not requiring it (controls). 229 and 111 variants differed significantly between cases and controls in cohorts 1 and 2, respectively. This included FBXO34, CNTN2, and TMCC2 previously linked with COVID-19 severity using association studies. Overall, we report SNPs in 26 known and 12 novel candidate genes with strong molecular evidence implicating them in the pathophysiology of life-threatening COVID-19 and post-recovery sequelae. Of these few notable known genes include, HLA-DQB1, AHSG, ALOX5AP, MUC5AC, SMPD1, SPG7, SPEG,GAS6, and SERPINA12. These results enhance our understanding of the pathomechanisms underlying the COVID-19 clinical spectrum and may be exploited to prioritize biomarkers for predicting disease severity, as well as to improve treatment strategies in individuals of European ancestry. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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8 pages, 473 KiB  
Article
Exploring the Role of Krebs von den Lungen-6 in Severe to Critical COVID-19 Patients
by Vito D’Agnano, Filippo Scialò, Francesco Perna, Lidia Atripaldi, Stefano Sanduzzi, Valentino Allocca, Maria Vitale, Lucio Pastore, Andrea Bianco and Fabio Perrotta
Life 2022, 12(8), 1141; https://0-doi-org.brum.beds.ac.uk/10.3390/life12081141 - 28 Jul 2022
Cited by 8 | Viewed by 1493
Abstract
COVID-19 encompasses a broad spectrum of clinical conditions caused by SARS-CoV-2 infection. More severe cases experience acute respiratory and/or multiorgan failure. KL-6 is a glycoprotein expressed mainly from type II alveolar cells with pro-fibrotic properties. Serum KL-6 concentrations have been found in patients [...] Read more.
COVID-19 encompasses a broad spectrum of clinical conditions caused by SARS-CoV-2 infection. More severe cases experience acute respiratory and/or multiorgan failure. KL-6 is a glycoprotein expressed mainly from type II alveolar cells with pro-fibrotic properties. Serum KL-6 concentrations have been found in patients with COVID-19. However, the relevance of KL-6 in patients with severe and critical COVID-19 has not been fully elucidated. Methods: Retrospective data from consecutive severe to critical COVID-19 patients were collected at UOC Clinica Pnuemologica “Vanvitelli”, A.O. dei Colli, Naples, Italy. The study included patients with a positive rhinopharyngeal swab for SARS-CoV-2 RNA with severe or critical COVID-19. Results: Among 87 patients, 24 had poor outcomes. The median KL-6 value in survivors was significantly lower when compared with dead or intubated patients (530 U/mL versus 1069 U/mL p < 0.001). KL-6 was correlated with body mass index (BMI) (r: 0.279, p: 0.009), lung ultrasound score (LUS) (r: 0.429, p < 0.001), Chung Score (r: 0.390, p < 0.001). KL-6 was associated with the risk of death or oro-tracheal intubation (IOT) after adjusting for gender, BMI, Charlson Index, Chung Score, and PaO2/FIO2 (OR 1.003 95% CI 1.001–1.004, p < 0.001). Serum KL-6 value of 968 has a sensitivity of 79.2%, specificity of 87.1%, PPV 70.4%, NPV 91.5%, AUC: O.85 for risk of death or IOT. Conclusions: The presented research highlights the relevance of serum KL-6 in severe to critical COVID-19 patients in predicting the risk of death or IOT. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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14 pages, 3186 KiB  
Article
How COVID-19 Hijacks the Cytoskeleton: Therapeutic Implications
by Maral Aminpour, Stuart Hameroff and Jack A. Tuszynski
Life 2022, 12(6), 814; https://0-doi-org.brum.beds.ac.uk/10.3390/life12060814 - 30 May 2022
Cited by 6 | Viewed by 3020
Abstract
The SARS-CoV-2 virus invades and replicates within host cells by “hijacking” biomolecular machinery, gaining control of the microtubule cytoskeleton. After attaching to membrane receptors and entering cells, the SARS-CoV-2 virus co-opts the dynamic intra-cellular cytoskeletal network of microtubules, actin, and the microtubule-organizing center, [...] Read more.
The SARS-CoV-2 virus invades and replicates within host cells by “hijacking” biomolecular machinery, gaining control of the microtubule cytoskeleton. After attaching to membrane receptors and entering cells, the SARS-CoV-2 virus co-opts the dynamic intra-cellular cytoskeletal network of microtubules, actin, and the microtubule-organizing center, enabling three factors that lead to clinical pathology: (1) viral load due to intra-cellular trafficking, (2) cell-to-cell spread by filopodia, and (3) immune dysfunction, ranging from hyper-inflammatory cytokine storm to ineffective or absent response. These factors all depend directly on microtubules and the microtubule-organizing center, as do cell functions such as mitosis and immune cell movement. Here we consider how the SARS-CoV-2 virus may “hijack” cytoskeletal functions by docking inside the microtubule-organizing center’s centriole “barrels”, enabling certain interactions between the virus’s positively charged spike (“S”) proteins and negatively charged C-termini of the microtubules that the centriole comprises, somewhat like fingers on a keyboard. This points to the potential benefit of therapies aimed not directly at the virus but at the microtubules and microtubule-organizing center of the host cell on which the virus depends. These therapies could range from anti-microtubule drugs to low-intensity ultrasound (megahertz mechanical vibrations) externally applied to the vagus nerve at the neck and/or to the spleen (since both are involved in mediating inflammatory response). Given that ultrasound imaging machines suitable for vagal/splenic ultrasound are available for clinical trials in every hospital, we recommend an alternative therapeutic approach for COVID-19 based on addressing and normalizing the host cell microtubules and microtubule-organizing centers co-opted by the SARS-CoV-2 virus. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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20 pages, 1087 KiB  
Communication
Prevention and Treatment of Life-Threatening COVID-19 May Be Possible with Oxygen Treatment
by Jukka Ylikoski, Jarmo Lehtimäki, Rauno Pääkkönen and Antti Mäkitie
Life 2022, 12(5), 754; https://0-doi-org.brum.beds.ac.uk/10.3390/life12050754 - 19 May 2022
Cited by 3 | Viewed by 3044
Abstract
Most SARS CoV-2 infections probably occur unnoticed or cause only cause a mild common cold that does not require medical intervention. A significant proportion of more severe cases is characterized by early neurological symptoms such as headache, fatigue, and impaired consciousness, including respiratory [...] Read more.
Most SARS CoV-2 infections probably occur unnoticed or cause only cause a mild common cold that does not require medical intervention. A significant proportion of more severe cases is characterized by early neurological symptoms such as headache, fatigue, and impaired consciousness, including respiratory distress. These symptoms suggest hypoxia, specifically affecting the brain. The condition is best explained by primary replication of the virus in the nasal respiratory and/or the olfactory epithelia, followed by an invasion of the virus into the central nervous system, including the respiratory centers, either along a transneural route, through disruption of the blood-brain barrier, or both. In patients, presenting with early dyspnea, the primary goal of therapy should be the reversal of brain hypoxia as efficiently as possible. The first approach should be intermittent treatment with 100% oxygen using a tight oronasal mask or a hood. If this does not help within a few hours, an enclosure is needed to increase the ambient pressure. This management approach is well established in the hypoxia-related diseases in diving and aerospace medicine and preserves the patient’s spontaneous breathing. Preliminary research evidence indicates that even a small elevation of the ambient pressure might be lifesaving. Other neurological symptoms, presenting particularly in long COVID-19, suggest imbalance of the autonomous nervous system, i.e., dysautonomia. These patients could benefit from vagal nerve stimulation. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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12 pages, 842 KiB  
Article
Can Lung Imaging Scores and Clinical Variables Predict Severe Course and Fatal Outcome in COVID-19 Pneumonia Patients? A Single-Center Observational Study
by Ivan Skopljanac, Mirela Pavicic Ivelja, Danijela Budimir Mrsic, Ognjen Barcot, Irena Jelicic, Josipa Domjanovic and Kresimir Dolic
Life 2022, 12(5), 735; https://0-doi-org.brum.beds.ac.uk/10.3390/life12050735 - 15 May 2022
Cited by 3 | Viewed by 2053
Abstract
COVID-19 prediction models mostly consist of combined clinical features, laboratory parameters, and, less often, chest X-ray (CXR) findings. Our main goal was to propose a prediction model involving imaging methods, specifically ultrasound. This was a single-center, retrospective cohort observational study of patients admitted [...] Read more.
COVID-19 prediction models mostly consist of combined clinical features, laboratory parameters, and, less often, chest X-ray (CXR) findings. Our main goal was to propose a prediction model involving imaging methods, specifically ultrasound. This was a single-center, retrospective cohort observational study of patients admitted to the University Hospital Split from November 2020 to May 2021. Imaging protocols were based on the assessment of 14 lung zones for both lung ultrasound (LUS) and computed tomography (CT), correlated to a CXR score assessing 6 lung zones. Prediction models for the necessity of mechanical ventilation (MV) or a lethal outcome were developed by combining imaging, biometric, and biochemical parameters. A total of 255 patients with COVID-19 pneumonia were included in the study. Four independent predictors were added to the regression model for the necessity of MV: LUS score, day of the illness, leukocyte count, and cardiovascular disease (χ2 = 29.16, p < 0.001). The model accurately classified 89.9% of cases. For the lethal outcome, only two independent predictors contributed to the regression model: LUS score and patient’s age (χ2 = 48.56, p < 0.001, 93.2% correctly classified). The predictive model identified four key parameters at patient admission which could predict an adverse outcome. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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15 pages, 1346 KiB  
Article
The Influence of Sex, Gender, and Age on COVID-19 Data in the Piedmont Region (Northwest Italy): The Virus Prefers Men
by Silvia De Francia, Alessandro Ferretti, Francesco Chiara, Sarah Allegra, Daniele Mancardi, Tiziano Giacomo Allice, Maria Grazia Milia, Gabriella Gregori, Elisa Burdino, Claudio Avanzini, Valeria Ghisetti and Alessandra Durio
Life 2022, 12(5), 643; https://0-doi-org.brum.beds.ac.uk/10.3390/life12050643 - 26 Apr 2022
Cited by 3 | Viewed by 2127
Abstract
Several important sex and gender differences in the clinical manifestation of diseases have been known for a long time but are still underestimated. The infectious Coronavirus 2019 disease pandemic has provided evidence of the importance of a sex and gender-based approach; it mainly [...] Read more.
Several important sex and gender differences in the clinical manifestation of diseases have been known for a long time but are still underestimated. The infectious Coronavirus 2019 disease pandemic has provided evidence of the importance of a sex and gender-based approach; it mainly affected men with worse symptomatology due to a different immune system, which is stronger in women, and to the Angiotensin-converting enzyme 2 and Transmembrane protease serine 2 roles which are differently expressed among the sexes. Additionally, women are more inclined to maintain social distance and smoke less. Analysis of data on the infectious Coronavirus 2019 disease testing from people admitted to the Amedeo di Savoia Hospital, a regional referral center for infectious diseases, has been applied to the whole of 2020 data (254,640 records). A high percentage of data in the dataset was not suitable due to a lack of information or entering errors. Among the suitable samples, records have been analyzed for positive/negative outcomes, matching records for unique subjects (N = 123,542), to evaluate individual recurrence of testing. Data are presented in age and sex-disaggregated ways. Analyses of the suitable sample also concerned the relation between testing and hospital admission motivation and symptoms. Our analysis indicated that a sex and gender-based approach is mandatory for patients and the National Health System’s sustainability. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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12 pages, 2363 KiB  
Article
Cellular Immune Response in Patients Immunized with Three Vaccine Doses of Different Vaccination Schemes Authorized by the Chilean Ministry of Health in January 2022
by Paz Beatriz Tabilo Valenzuela, Gabriela Flores Balter, Gustavo Saint-Pierre Contreras, Daniel Conei Valencia, Catalina Moreno Calderón, Constanza Bohle Venegas, Marcia Guajardo Rivera, Francisco Silva Ojeda and Maria Jesus Vial Covarrubias
Life 2022, 12(4), 534; https://0-doi-org.brum.beds.ac.uk/10.3390/life12040534 - 05 Apr 2022
Cited by 2 | Viewed by 2288
Abstract
In December 2019, a case of atypical pneumonia was reported in Wuhan, China. It was named COVID-19 and caused by SARS-CoV-2. In a few months, scientific groups around the world developed vaccines to reduce the disease’s severity. The objective was to evaluate the [...] Read more.
In December 2019, a case of atypical pneumonia was reported in Wuhan, China. It was named COVID-19 and caused by SARS-CoV-2. In a few months, scientific groups around the world developed vaccines to reduce the disease’s severity. The objective was to evaluate the humoral and cellular immune response post immunization with three different vaccination schedules administered in Chile until January 2022. Sixty volunteers were recruited with a three-dose schedule, who had no history of infection nor close contact with a positive patient. IgG against the spike antigenic domain was detected, and the neutralization capacity against two groups of variants, Original/Alpha and Beta/Gamma, was also measured. Finally, the cellular response with interferon release was measured through IGRA. Results showed that there were significant differences in the neutralizing antibodies for the original and alpha variant when comparing three Comirnaty doses with Coronavac and Vaxzevria. A high number of reactive subjects against the different SARS-CoV-2 variants, alpha, gamma, and delta, were observed, with no significant differences between any of the three schemes, confirming the existence of a cellular immune response against SARS-CoV-2. In conclusion, the three vaccine schemes generated a cellular immune response in these volunteers. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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11 pages, 661 KiB  
Article
Convalescent Plasma for Hospitalized COVID-19 Patients: A Single-Center Experience
by Massimo Franchini, Claudia Glingani, Giuseppe De Donno, Giuseppe Lucchini, Massimiliano Beccaria, Massimo Amato, Gian Paolo Castelli, Leonardo Bianciardi, Mauro Pagani, Marco Ghirardini, Giuseppe Puma, Barbara Presciuttini, Maria Teresa Costantino, Marilena Frigato, Verena Crosato, Giorgio Tiecco, Alice Mulè, Dorothea Angela Papalia, Francesco Inglese, Fabio Spreafico, Martina Garuti, Antonietta Pecoriello, Giulia Cervi, Graziana Greco, Vanni Galavotti, Tiziana Santini, Angela Berselli, Carlo Montalto, Riccardo Bertoletti, Simona Aurelia Bellometti, Enrico Capuzzo, Dario Benazzi, Gianpaolo Grisolia, Fabio Pajola, Raffaello Stradoni, Matteo Zani, Adriano Verzola, Vito Codeluppi, Silvia Vesentini, Elisa Bellocchio, Marco Candini, Giorgina Ambrosi, Francesca Carandina, Cleante Scarduelli, Albino Reggiani, Salvatore Casari and on behalf of Convalescent Plasma Study Groupadd Show full author list remove Hide full author list
Life 2022, 12(3), 420; https://0-doi-org.brum.beds.ac.uk/10.3390/life12030420 - 14 Mar 2022
Cited by 9 | Viewed by 2649
Abstract
In Winter 2020, Italy, and in particular the Lombardy region, was the first country in the Western hemisphere to be hit by the COVID-19 pandemic. Plasma from individuals recovered from COVID-19 (COVID-19 convalescent plasma, CCP) was the first therapeutic tool adopted to counteract [...] Read more.
In Winter 2020, Italy, and in particular the Lombardy region, was the first country in the Western hemisphere to be hit by the COVID-19 pandemic. Plasma from individuals recovered from COVID-19 (COVID-19 convalescent plasma, CCP) was the first therapeutic tool adopted to counteract the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). In this retrospective cohort study, we report the experience of the city hospital of Mantua, Lombardy region, on the compassionate use of CCP in patients hospitalized for severe COVID-19. Between April 2020 and April 2021, 405 consecutive COVID-19 patients received 657 CCP units with a median anti-SARS-CoV-2 neutralizing antibody (nAb) titer of 160 (interquartile range (IQR), 80–320). Their median age was 68 years (IQR, 56–78 years), and 62% were males. At enrollment, 55% of patients had an increased body mass index (BMI), and 25.6% had at least three comorbidities. The 28-day crude mortality rate was 12.6% (51/405). Young age (<68 years), mild disease (admission to low-intensity departments) and early treatment (<7 days from symptoms onset) with high nAb titer (≥320) CCP were found as independently associated with a favorable response to CCP treatment. No safety concerns were recorded, with a rate of CCP-related adverse reactions (all of mild intensity) of 1.3%. In our real-life experience, the first in the western world, early administration of high-titer CCP was a safe and effective treatment for hospitalized COVID-19 patients. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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10 pages, 2196 KiB  
Article
SARS-CoV-2 Inactivation Simulation Using 14 MeV Neutron Irradiation
by Fang Liu, Zhengtong Zhong, Bin Liu, Tianze Jiang, Hongchi Zhou, Guanda Li, Xin Yuan, Peiguang Yan, Fenglei Niu and Xiaoping Ouyang
Life 2021, 11(12), 1372; https://0-doi-org.brum.beds.ac.uk/10.3390/life11121372 - 09 Dec 2021
Cited by 6 | Viewed by 2191
Abstract
The SARS-CoV-2 virus is deadly, contagious, can cause COVID-19 disease, and endangers public health and safety. The development of SARS-CoV-2 inactivation technology is crucial and imminent in current pandemic period. Neutron radiation is usually used to sterilize viruses because neutron radiation is 10 [...] Read more.
The SARS-CoV-2 virus is deadly, contagious, can cause COVID-19 disease, and endangers public health and safety. The development of SARS-CoV-2 inactivation technology is crucial and imminent in current pandemic period. Neutron radiation is usually used to sterilize viruses because neutron radiation is 10 times more effective than gamma-rays in inactivating viruses. In this work we established a closed SARS-CoV-2 inactivation container model by the Monte Carlo method and simulated the inactivation performance by using several different neutrons sources. To study the effects of inactivation container factors, including the reflector thickness, the type of the reflector material, the SARS-CoV-2 layer area and the distance from the radiation source on the energy deposition of a single neutron particle in SARS-CoV-2 sample, we simulated the neutron energy deposition on a SARS-CoV-2 sample. The simulation results indicate that the saturated thicknesses of reflector materials for graphite, water and paraffin are approximately 30 cm, 15 cm, and 10 cm, respectively, and the energy deposition (radiation dose) becomes larger when the SARS-CoV-2 layer area is smaller and the SARS-CoV-2 layer is placed closer to the neutron source. The calculated single-neutron energy deposition on 10 × 10 cm2 SARS-CoV-2 layer is about 3.0059 × 10−4 MeV/g with graphite as the reflection layer, when the 14 MeV neutron source intensity is 1012 n/s and the SARS-CoV-2 layer is 5 cm away from the neutron source. If the lethal dose of SARS-CoV-2 is assumed as the IAEA recommended reference dose, 25 kGy, the SARS-CoV-2 could be decontaminated in about 87 min, and the sterilization time could be less than 52 s if the 14 MeV neutron intensity is increased to 1014 n/s. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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Review

Jump to: Editorial, Research, Other

24 pages, 444 KiB  
Review
Safety of COVID-19 Vaccines: Spotlight on Neurological Complications
by Giacomo Tondo, Eleonora Virgilio, Andrea Naldi, Angelo Bianchi and Cristoforo Comi
Life 2022, 12(9), 1338; https://0-doi-org.brum.beds.ac.uk/10.3390/life12091338 - 29 Aug 2022
Cited by 17 | Viewed by 4268
Abstract
The COVID-19 pandemic has led to unprecedented demand on the global healthcare system. Remarkably, at the end of 2021, COVID-19 vaccines received approvals for human use in several countries worldwide. Since then, a solid base for response in the fight against the virus [...] Read more.
The COVID-19 pandemic has led to unprecedented demand on the global healthcare system. Remarkably, at the end of 2021, COVID-19 vaccines received approvals for human use in several countries worldwide. Since then, a solid base for response in the fight against the virus has been placed. COVID-19 vaccines have been shown to be safe and effective drugs. Nevertheless, all kinds of vaccines may be associated with the possible appearance of neurological complications, and COVID-19 vaccines are not free from neurological side effects. Neurological complications of COVID-19 vaccination are usually mild, short-duration, and self-limiting. However, severe and unexpected post-vaccination complications are rare but possible events. They include the Guillain-Barré syndrome, facial palsy, other neuropathies, encephalitis, meningitis, myelitis, autoimmune disorders, and cerebrovascular events. The fear of severe or fatal neurological complications fed the “vaccine hesitancy” phenomenon, posing a vital communication challenge between the scientific community and public opinion. This review aims to collect and discuss the frequency, management, and outcome of reported neurological complications of COVID-19 vaccines after eighteen months of the World Health Organization’s approval of COVID-19 vaccination, providing an overview of safety and concerns related to the most potent weapon against the SARS-CoV-2. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
12 pages, 2814 KiB  
Review
How an Outbreak of COVID-19 Circulated Widely in Nepal: A Chronological Analysis of the National Response to an Unprecedented Pandemic
by Basu Dev Pandey, Mya Myat Ngwe Tun, Kishor Pandey, Shyam Prakash Dumre, Khin Mya Nwe, Yogendra Shah, Richard Culleton, Yuki Takamatsu, Anthony Costello and Kouichi Morita
Life 2022, 12(7), 1087; https://0-doi-org.brum.beds.ac.uk/10.3390/life12071087 - 20 Jul 2022
Cited by 8 | Viewed by 2859
Abstract
Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first COVID-19 case was reported in Wuhan, China, in December 2019. In March 2020, the World Health Organization (WHO) declared COVID-19 a global pandemic. The first COVID-19 [...] Read more.
Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first COVID-19 case was reported in Wuhan, China, in December 2019. In March 2020, the World Health Organization (WHO) declared COVID-19 a global pandemic. The first COVID-19 case in Nepal was reported in January 2020 in a Nepalese man who had returned from Wuhan to Nepal. This study aims to evaluate the government of Nepal’s (GoN) response to the COVID-19 pandemic and explore ways to prevent COVID-19 and other pandemic diseases in the future. As of May 2022, a total of 979,140 cases and 11,951 deaths associated with COVID-19 have been reported in Nepal. To prevent the spread of the virus, the GoN initiated various preventive and control measures, including lockdown strategies. The effects of COVID-19 are expected to persist for many years; the best strategies a resource-limited country such as Nepal can implement to control pandemic diseases such as COVID-19 in the pre-vaccine stage are to increase testing, tracing, and isolation capacity. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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14 pages, 613 KiB  
Review
Post-COVID-19 Condition: Where Are We Now?
by Paula Boaventura, Sofia Macedo, Filipa Ribeiro, Sónia Jaconiano and Paula Soares
Life 2022, 12(4), 517; https://0-doi-org.brum.beds.ac.uk/10.3390/life12040517 - 31 Mar 2022
Cited by 23 | Viewed by 9395
Abstract
COVID-19 is currently considered a systemic infection involving multiple systems and causing chronic complications. Compared to other post-viral fatigue syndromes, these complications are wider and more intense. The most frequent symptoms are profound fatigue, dyspnea, sleep difficulties, anxiety or depression, reduced lung capacity, [...] Read more.
COVID-19 is currently considered a systemic infection involving multiple systems and causing chronic complications. Compared to other post-viral fatigue syndromes, these complications are wider and more intense. The most frequent symptoms are profound fatigue, dyspnea, sleep difficulties, anxiety or depression, reduced lung capacity, memory/cognitive impairment, and hyposmia/anosmia. Risk factors for this condition are severity of illness, more than five symptoms in the first week of the disease, female sex, older age, the presence of comorbidities, and a weak anti-SARS-CoV-2 antibody response. Different lines of research have attempted to explain these protracted symptoms; chronic persistent inflammation, autonomic nervous system disruption, hypometabolism, and autoimmunity may play a role. Due to thyroid high ACE expression, the key molecular complex SARS-CoV-2 uses to infect the host cells, thyroid may be a target for the coronavirus infection. Thyroid dysfunction after SARS-CoV-2 infection may be a combination of numerous mechanisms, and its role in long-COVID manifestations is not yet established. The proposed mechanisms are a direct effect of SARS-CoV-2 on target cells, an indirect effect of systemic inflammatory immune response, and a dysfunction of the hypothalamic-pituitary-thyroid (HPT) axis leading to decreased serum TSH. Only a few studies have reported the thyroid gland status in the post-COVID-19 condition. The presence of post-COVID symptoms deserves recognition of COVID-19 as a cause of post-viral fatigue syndrome. It is important to recognize the affected individuals at an early stage so we can offer them the most adequate treatments, helping them thrive through the uncertainty of their condition. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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13 pages, 901 KiB  
Review
Asthma and COVID-19 Associations: Focus on IgE-Related Immune Pathology
by Chung-Jen Wang, Shih-Lung Cheng and Sow-Hsong Kuo
Life 2022, 12(2), 153; https://0-doi-org.brum.beds.ac.uk/10.3390/life12020153 - 20 Jan 2022
Cited by 3 | Viewed by 4550
Abstract
Management of patients with asthma during the coronavirus disease 2019 (COVID-19) pandemic is a concern, especially since asthma predisposes patients to respiratory problems. Interestingly, asthma characterized by type 2 inflammation, also known as T-helper type 2-high endotype, displays a cellular and molecular profile [...] Read more.
Management of patients with asthma during the coronavirus disease 2019 (COVID-19) pandemic is a concern, especially since asthma predisposes patients to respiratory problems. Interestingly, asthma characterized by type 2 inflammation, also known as T-helper type 2-high endotype, displays a cellular and molecular profile that may confer protective effects against COVID-19. The results of experimental and clinical studies have established the actions of immunoglobulin E (IgE) in inducing airway hyperreactivity and weakening an interferon-mediated antiviral response following respiratory viral infection. Robust evidence supports the beneficial effect of the anti-IgE biologic treatment omalizumab on reducing respiratory virus-induced asthma exacerbations and reducing the frequency, duration, and severity of respiratory viral illness in patients with asthma. Indeed, accumulating reports of patients with severe asthma treated with omalizumab during the pandemic have reassuringly shown that continuing omalizumab treatment during COVID-19 is safe, and in fact may help prevent the severe course of COVID-19. Accordingly, guidance issued by the Global Initiative for Asthma recommends that all patients with asthma continue taking their prescribed asthma medications, including biologic therapy, during the COVID-19 pandemic. The impact of biologic treatments on patients with asthma and COVID-19 will be better understood as more evidence emerges. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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Other

6 pages, 523 KiB  
Case Report
The Cumulative Detrimental Effect of COVID-19 Pneumonia in a Patient with Myasthenic Crisis: A Case Report and Overview of the Literature
by Georgiana-Cristina Buzatu, Florin-Teodor Bobirca, Sebastian Isac, Oana Antonia Mihalache, Mihail Cotorogea-Simion, Alina Tita, Cristian Cobilinschi, Maria Daniela Tanasescu, Anca Bobirca and Gabriela Droc
Life 2022, 12(10), 1482; https://0-doi-org.brum.beds.ac.uk/10.3390/life12101482 - 23 Sep 2022
Cited by 1 | Viewed by 1608
Abstract
Background: As the COVID-19 pandemic reached its peak, it became unavoidable that patients with other risk factors for severe pulmonary impairment (such as neuromuscular illnesses) would become afflicted. While the subject of myasthenic crisis secondary to COVID-19 pneumonia represents an interesting topic in [...] Read more.
Background: As the COVID-19 pandemic reached its peak, it became unavoidable that patients with other risk factors for severe pulmonary impairment (such as neuromuscular illnesses) would become afflicted. While the subject of myasthenic crisis secondary to COVID-19 pneumonia represents an interesting topic in the literature, we could not find consistent data that include, as a novel therapeutic approach, both intravenous immunoglobulin and plasma exchange therapy for the treatment of these two concurrent diseases. Case summary: A 69-year-old man with known seropositive generalized myasthenia gravis, hypertension, ischaemic heart disease, NYHA class II-III heart failure, cerebrovascular disease, and recurrent urinary tract infections, was admitted to the ICU for mixed acute respiratory failure, elevated serum lactate and liver function enzymes, and severe thrombocytopenia. A SARS-CoV-2 PCR test was positive, despite a previous COVID-19 pneumonia episode, 10 months prior to the current one. The patient had a recent ICU admission for a myasthenic crisis, which required non-invasive mechanical ventilation and intravenous immunoglobulin therapy. He received supportive therapy, as well as etiological (intravenous remdesivir, plasmapheresis and intravenous dexamethasone). Fifteen days after admission, the patient was transferred to the neurological ward, whence he left 20 days later, with no apparent sequelae. Conclusions: Subsequent intravenous immunoglobulins and plasma exchange therapy appear to be effective and safe in patients with simultaneous acute myasthenic episode and COVID-19 pneumonia. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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26 pages, 448 KiB  
Protocol
Protocol of an Exploratory Single-Arm Study to Evaluate the Safety and Immunogenicity of KD-414 as a Booster Vaccine for SARS-CoV-2 in Healthy Adults (KAPIVARA)
by Yuriko Terayama, Noriko Tomita, Junko Terada-Hirashima, Yukari Uemura, Yosuke Shimizu, Junko S. Takeuchi, Yuki Takamatsu, Kenji Maeda, Ayako Mikami, Mugen Ujiie and Wataru Sugiura
Life 2022, 12(7), 966; https://0-doi-org.brum.beds.ac.uk/10.3390/life12070966 - 27 Jun 2022
Cited by 4 | Viewed by 1739
Abstract
Background: The coronavirus disease 2019 (COVID-19) pandemic is currently ongoing, and there have been significant efforts in the development of COVID-19 vaccines. However, the neutralizing antibody titers in vaccinated individuals are reported to progressively decrease over time. Japanese pharmaceutical companies have published the [...] Read more.
Background: The coronavirus disease 2019 (COVID-19) pandemic is currently ongoing, and there have been significant efforts in the development of COVID-19 vaccines. However, the neutralizing antibody titers in vaccinated individuals are reported to progressively decrease over time. Japanese pharmaceutical companies have published the results of Phase I and II studies on the safety and efficacy of different vaccines. Final clinical trials will be conducted with the aim of practical application by March 2023. To effectively utilize vaccines developed by Japanese companies, the efficacy and safety of a booster dose (i.e., third vaccination) must be evaluated among individuals who have received three doses of different vaccines. Methods: This protocol describes a study that aims to examine the effect of a booster dose of “KD-414”, a novel Japanese inactivated vaccine, on antibody titers among participants involved in a previous study. Volunteers in this protocol will be recruited from participants in the previous study and immunized with KD-414 after obtaining consent. The antibody titers, before and after immunization with KD-414, among participants who previously received two doses of the BNT162b2 mRNA vaccine, will be comparatively analyzed. Discussion: The reactogenicity and immunogenicity of seven different COVID-19 vaccines including an inactivated vaccine as a third dose after two doses of ChAdOx1 nCov-19 or BNT162b2, has been tested previously, and found to be superior to control (quadrivalent meningococcal conjugate vaccine) regardless of which vaccine had been received during the initial course. This suggests that many types of third booster doses are efficacious. It is anticipated that this study will provide evidence of the safety and immunogenicity of KD-414 as a booster vaccine, which will have profound public health implications. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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13 pages, 265 KiB  
Protocol
A Multi-Center, Open-Label, Randomized Controlled Trial to Evaluate the Efficacy of Convalescent Plasma Therapy for Coronavirus Disease 2019: A Trial Protocol (COVIPLA-RCT)
by Noriko Tomita, Sho Saito, Junko Terada-Hirashima, Ayako Mikami, Yukari Uemura, Satoshi Kutsuna, Hidetoshi Nomoto, Kyoko Fujisawa, Maki Nagashima, Mari Terada, Shinobu Ashida, Shinichiro Morioka, Masahiro Satake, Akira Hangaishi, Tomiteru Togano, Katsuyuki Shiratori, Yuki Takamatsu, Kenji Maeda, Norio Ohmagari, Wataru Sugiura and Hiroaki Mitsuyaadd Show full author list remove Hide full author list
Life 2022, 12(6), 856; https://0-doi-org.brum.beds.ac.uk/10.3390/life12060856 - 08 Jun 2022
Cited by 4 | Viewed by 1976
Abstract
Background: Coronavirus disease 2019 is a global public health concern. As of December 2020, the therapeutic agents approved for coronavirus disease 2019 in Japan were limited to two drugs: remdesivir, an antiviral drug, granted a Special Approval for Emergency on 7 May 2020, [...] Read more.
Background: Coronavirus disease 2019 is a global public health concern. As of December 2020, the therapeutic agents approved for coronavirus disease 2019 in Japan were limited to two drugs: remdesivir, an antiviral drug, granted a Special Approval for Emergency on 7 May 2020, and dexamethasone, which has an anti-inflammatory effect. The aim of this study is to evaluate the efficacy of convalescent plasma collected from donors who recovered from coronavirus disease 2019. Methods: This is an open-label, randomized controlled trial comprising two groups: a convalescent plasma and a standard-of-care group. Plasma administered to patients with coronavirus disease 2019 randomized in the convalescent plasma group of this trial will be plasma that has been collected and stored in an associated study. Patients with a diagnosis of mild coronavirus disease 2019 will be included in this trial. The efficacy of convalescent plasma transfusion will be evaluated by comparing the convalescent plasma group to the standard-of-care group (without convalescent plasma transfusion) with respect to changes in the viral load and other measures. The primary endpoint will be time-weighted average changes in the SARS-CoV-2 virus load in nasopharyngeal swabs from day 0 to days 3 and 5. It is hypothesized that the intervention should result in a decrease in the viral load in the convalescent plasma group until day 5. This endpoint has been used as a change in viral load has and been used as an index of therapeutic effect in several previous studies. Discussion: The proposed trial has the potential to prevent patients with mild COVID-19 from developing a more severe illness. Several RCTs of convalescent plasma therapy have already been conducted in countries outside of Japan, but no conclusion has been reached with respect to the efficacy of convalescent plasma therapy, which is likely in part because of the heterogeneity of the types of target patients, interventions, and endpoints among trials. Actually, previous clinical trials on plasma therapy have shown inconsistent efficacy and are sometimes ineffective in COVID-19 patients with severe disease, which is due to unmeasured neutralizing antibody titer in the COVID-19 convalescent plasma. To improve this issue, in this study, we measure neutralizing activity of convalescent plasma before administration and provide the plasma with high neutralizing activity to the subjects. It is hoped that this study will further evidence to support the role of convalescent plasma therapy in COVID-19. Full article
(This article belongs to the Special Issue COVID-19 Prevention and Treatment)
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