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1.
Front Psychiatry ; 12: 626150, 2021.
Article in English | MEDLINE | ID: covidwho-1362338

ABSTRACT

Cannabis is increasingly used by individuals with mental health diagnoses and often purported to treat anxiety and various other psychiatric symptoms. Yet support for using cannabis as a psychiatric treatment is currently limited by a lack of evidence from rigorous placebo-controlled studies. While regulatory hurdles and other barriers make clinical trials of cannabis challenging to conduct, addiction researchers have decades of experience studying cannabis use in human laboratory models. These include methods to control cannabis administration, to delineate clinical and mechanistic aspects of cannabis use, and to evaluate potential treatment applications for cannabis and its constituents. In this paper, we review these human laboratory procedures and describe how each can be applied to study cannabis use in patients with psychiatric disorders. Because anxiety disorders are among the most common psychiatric illnesses affecting American adults, and anxiety relief is also the most commonly-reported reason for medicinal cannabis use, we focus particularly on applying human laboratory models to study cannabis effects in individuals with anxiety and related disorders. Finally, we discuss how these methods can be integrated to study cannabis effects in other psychiatric conditions and guide future research in this area.

2.
Medicine (Baltimore) ; 100(19): e25876, 2021 May 14.
Article in English | MEDLINE | ID: covidwho-1262272

ABSTRACT

BACKGROUND: Patients infected with a virus usually lack vitamin C. High-dose vitamin C has an antiviral effect, and has been used by several researchers to treat COVID-19 by intravenous infusion, achieving good results. However, the efficacy and safety of vitamin C in the treatment of patients with COVID-19 remain unclear. Thus, the aim of the present study was to investigate the efficacy of high-dose vitamin C infusion in the treatment of patients with COVID-19. METHODS: Electronic databases were searched, including PubMed, EMBASE, Cochrane Central Register of Controlled Trials, Web of Science, China National Knowledge Infrastructure database, Chinese Wanfang database, and Chinese Biomedical Literature database. The aim was to collect randomized controlled trials of high-dose vitamin C infusion in the treatment of patients with COVID-19, with the retrieval time being from the establishment of the database to March 2021. In accordance with the pre-designed inclusion/exclusion criteria, all data were extracted independently by 2 researchers. To assess the risk bias in the studies, the Cochrane collaboration's tool for assessing risk of bias was used to assess the risk bias in the studies, while meta-analysis was performed using Revman 5.3 software. RESULTS: In the present study, a high-quality comprehensive evaluation is provided of high-dose vitamin C infusion in the treatment of patients with COVID-19. CONCLUSION: Further convincing evidence for the clinical treatment of COVID-19 is provided, in addition to evidence-based guidance for clinical practice. PROSPERO REGISTRATION NUMBER: CRD42021246342.


Subject(s)
Ascorbic Acid/therapeutic use , COVID-19/drug therapy , Vitamins/therapeutic use , Ascorbic Acid/administration & dosage , Ascorbic Acid/adverse effects , Dose-Response Relationship, Drug , Humans , Infusions, Intravenous , Interleukin-6/blood , Length of Stay , Randomized Controlled Trials as Topic , Research Design , Respiration, Artificial/statistics & numerical data , SARS-CoV-2 , Vitamins/administration & dosage , Vitamins/adverse effects
3.
J Hum Rights Soc Work ; : 1-12, 2021 May 26.
Article in English | MEDLINE | ID: covidwho-1244637

ABSTRACT

In this paper, the researchers argue that the repercussions of the Coronavirus Disease 19 (COVID-19) pandemic are taking a toll on rural women, not as a new phenomenon, but as an amplifier for their historical calamities dovetailed by climate change. The declaration of COVID-19 as a global pandemic by the World Health Organisation ignited widespread pronouncements of national state of disasters in various countries around the globe including Zimbabwe. Subsequently, like other countries, Zimbabwe followed the precautionary measures outlined by the WHO and pronounced its national lockdown to curtail the transmission of the virus. This paper intends to demonstrate how convergence of the COVID-19 pandemic and climate change impacts serves as a double injustice for rural women in Nyanga communities, Zimbabwe. The study was qualitative in nature guided by the descriptive research design. Twenty participants comprising rural women and social workers were selected using purposive and convenience sampling techniques. Data were collected using focus group discussions and key informant interviews. The Thematic Content Analysis was followed to analyse the data from which the findings were derived. This study established that the COVID-19 pandemic is enhancing the catastrophic implications created by climate change on rural women whose food security systems are shattered, livelihood strategies maimed, caregiving roles burgeoning, and access to healthcare systems compromised. This daunting double impact is aggravated by gender inequalities, social exclusion and patriarchal dominance. The centrality of social justice to social work connotes that the profession has a tendentious responsibility to stand in the gap and liberate women from the jaws of these double catastrophes (climate change and COVID-19).

4.
Sci Rep ; 11(1): 10678, 2021 05 21.
Article in English | MEDLINE | ID: covidwho-1238016

ABSTRACT

With an urgent need for bedside imaging of coronavirus disease 2019 (COVID-19), this study's main goal was to assess inter- and intraobserver agreement in lung ultrasound (LUS) of COVID-19 patients. In this single-center study we prospectively acquired and evaluated 100 recorded ten-second cine-loops in confirmed COVID-19 intensive care unit (ICU) patients. All loops were rated by ten observers with different subspeciality backgrounds for four times by each observer (400 loops overall) in a random sequence using a web-based rating tool. We analyzed inter- and intraobserver variability for specific pathologies and a semiquantitative LUS score. Interobserver agreement for both, identification of specific pathologies and assignment of LUS scores was fair to moderate (e.g., LUS score 1 Fleiss' κ = 0.27; subpleural consolidations Fleiss' κ = 0.59). Intraobserver agreement was mostly moderate to substantial with generally higher agreement for more distinct findings (e.g., lowest LUS score 0 vs. highest LUS score 3 (median Fleiss' κ = 0.71 vs. 0.79) or air bronchograms (median Fleiss' κ = 0.72)). Intraobserver consistency was relatively low for intermediate LUS scores (e.g. LUS Score 1 median Fleiss' κ = 0.52). We therefore conclude that more distinct LUS findings (e.g., air bronchograms, subpleural consolidations) may be more suitable for disease monitoring, especially with more than one investigator and that training material used for LUS in point-of-care ultrasound (POCUS) should pay refined attention to areas such as B-line quantification and differentiation of intermediate LUS scores.


Subject(s)
COVID-19/diagnostic imaging , Lung/diagnostic imaging , Point-of-Care Systems , SARS-CoV-2 , COVID-19/therapy , Female , Humans , Male , Middle Aged , Monitoring, Physiologic , Observer Variation , Prospective Studies , Ultrasonography
5.
BMC Public Health ; 21(1): 709, 2021 04 13.
Article in English | MEDLINE | ID: covidwho-1181101

ABSTRACT

BACKGROUND: In December 2019, the Chinese city of Wuhan reported a novel pneumonia caused by COVID-19. While the COVID-19 pandemic has been increasingly affecting the world, the occurrence of disasters resulted in complex emergencies. The present review is aimed to identify the literature focused on health system response to coincidence of COVID-19 and disasters as well as describing their finding, implications and lessons-learned. METHODS: This study was conducted and reported based on PRISMA guideline. The databases of Web of Sciences, PubMed, Scopus, Google Scholar and World Health Organization Library were searched. The inclusion criteria were all forms of published articles which investigated the coincidence of disasters and COVID-19 pandemic. Using the title and abstract screening, the selections of studies were performed by two researchers. Once, the relevant papers were finalized, the analysis was done in two parts of descriptive analysis and implications for health systems. RESULTS: Out of 1245 studies generated by initial search, a number of 13 articles was selected for final analysis. Earthquake was the most frequent disaster which its coincidence with COVID-19 was studied by researchers (31%). The implications of researchers for healthcare system were explained in three sections of climatic events, earthquakes and all hazard approach in relation to COVID-19. CONCLUSION: Extracting the lessons learned from the regions affected by disasters at the time of COVID-19 pandemic can be helpful for healthcare professionals and policy-makers to improve their preparedness and response during disasters and a serious pandemic such as COVID-19. Further research is needed to identify the factors which strengthen the preparedness of health system for the dual risk of natural hazards and pandemics.


Subject(s)
COVID-19 , Disasters , Health Care Sector , Health Care Sector/organization & administration , Humans
6.
Account Res ; 29(3): 133-164, 2022 04.
Article in English | MEDLINE | ID: covidwho-1160891

ABSTRACT

Journal impact factors, publication charges and assessment of quality and accuracy of scientific research are critical for researchers, managers, funders, policy makers, and society. Editors and publishers compete for impact factor rankings, to demonstrate how important their journals are, and researchers strive to publish in perceived top journals, despite high publication and access charges. This raises questions of how top journals are identified, whether assessments of impacts are accurate and whether high publication charges borne by the research community are justified, bearing in mind that they also collectively provide free peer-review to the publishers. Although traditional journals accelerated peer review and publication during the COVID-19 pandemic, preprint servers made a greater impact with over 30,000 open access articles becoming available and accelerating a trend already seen in other fields of research. We review and comment on the advantages and disadvantages of a range of assessment methods and the way in which they are used by researchers, managers, employers and publishers. We argue that new approaches to assessment are required to provide a realistic and comprehensive measure of the value of research and journals and we support open access publishing at a modest, affordable price to benefit research producers and consumers.


Subject(s)
COVID-19 , Pandemics , Humans , Journal Impact Factor , Peer Review , SARS-CoV-2
7.
IEEE Pulse ; 12(1): 28-30, 2021.
Article in English | MEDLINE | ID: covidwho-1091098

ABSTRACT

Researchers have developed new ways to use the extremely versatile material graphene, and a company is now building on that work to manufacture an air-filtration device that kills bacteria and viruses-including the virus responsible for coronavirus disease 2019 (COVID-19)-on contact.


Subject(s)
Air Filters , Air Microbiology , COVID-19/prevention & control , Pandemics , SARS-CoV-2 , Biomedical Engineering , COVID-19/transmission , COVID-19/virology , Equipment Design , Exhalation , Graphite , Humans
8.
J Virol Methods ; 290: 114070, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1046238

ABSTRACT

Viral infections are one of the main cause of diseases worldwide due to the rising trends of migration, urbanization and global mobility of humans. The outbreak of corona virus diseases caused by SARS-CoV (year 2003), MERS-CoV (year 2012) and SARS-CoV-2 (year 2019) raised global health concerns. The side effects associated with the conventional drugs and increase in cases of anti-microbial resistance have led the researchers to switch to natural sources, especially plants, as they have immense potential to be used as antiviral agents. The aim of the article is to summarize the evidences of the bioactive phytocompounds from different plants as an effective alternative for the treatment of infections caused by coronaviruses. However, the use of most plant compounds succumbs to limitations due to lack of experimental evidences and safety studies. Therefore, further research and studies are required to validate their therapeutic uses for wide application of plant-based medicine, including anti-virals.


Subject(s)
Antiviral Agents/pharmacology , Coronavirus Infections/virology , Coronavirus/drug effects , Phytochemicals/pharmacology , Antiviral Agents/chemistry , Antiviral Agents/therapeutic use , Coronavirus/classification , Coronavirus/physiology , Coronavirus Infections/diagnosis , Coronavirus Infections/drug therapy , Genome, Viral , Humans , Phytochemicals/chemistry , Phytochemicals/therapeutic use , Plants, Medicinal/chemistry , Viral Proteins/antagonists & inhibitors , Viral Proteins/metabolism
9.
Probl Endokrinol (Mosk) ; 66(4): 77-81, 2020 10 01.
Article in Russian | MEDLINE | ID: covidwho-994561

ABSTRACT

The WHO has declared a SARS-CoV-2 pandemic. During a pandemic, the researches aimed at finding the new treatments for SARS-CoV-2 become relevant. The review focuses on studies of androgens and antiandrogens in this disease. Since the beginning of the COVID-19 epidemic, it has been noted that men have more severe forms of infection and higher mortality. The main cause of both the severity of the disease and the high mortality of men from COVID-19 are associated with androgens. It was found that patients receiving androgen deprivation are less likely to become infected and easily tolerate COVID-19. The researchers explain the effect of the therapy by the effect on the TMPRSS2 protein. It was found that both TMPRSS2 expression and a more severe course of coronavirus infection are observed in men with hyperandrogenism - androgenic alopecia, acne, excessive facial hair growth and increased skin oiliness. In this regard, some researchers suggest to use androgen deprivation for men at high risk of developing COVID-19. Steroid and non-steroidal antiandrogens are used for androgen deprivation. At the same time, obtaned scientific data on the relationship of severe forms and mortality of COVID-19 with low testosterone levels leads to a hypothesis about the possibility of a positive effect not of androgen devrivation therapy but of androgen replacement therapy in case of hypogonadism have diagnosed. These studies have not been completed recently, and data on the effectiveness and safety of antiandrogens and androgens in the treatment of a new coronavirus infection require clarification.


Subject(s)
Androgens/genetics , COVID-19/genetics , Hyperandrogenism/epidemiology , Serine Endopeptidases/genetics , Androgen Antagonists/therapeutic use , COVID-19/complications , COVID-19/drug therapy , COVID-19/virology , Humans , Hyperandrogenism/complications , Hyperandrogenism/drug therapy , Hyperandrogenism/virology , Male , Pandemics , SARS-CoV-2/pathogenicity
10.
Cytotherapy ; 23(6): 471-482, 2021 06.
Article in English | MEDLINE | ID: covidwho-952449

ABSTRACT

The end of 2019 saw the beginning of the coronavirus disease 2019 (COVID-19) pandemic that soared in 2020, affecting 215 countries worldwide, with no signs of abating. In an effort to contain the spread of the disease and treat the infected, researchers are racing against several odds to find an effective solution. The unavailability of timely and affordable or definitive treatment has caused significant morbidity and mortality. Acute respiratory distress syndrome (ARDS) caused by an unregulated host inflammatory response toward the viral infection, followed by multi-organ dysfunction or failure, is one of the primary causes of death in severe cases of COVID-19 infection. Currently, empirical management of respiratory and hematological manifestations along with anti-viral agents is being used to treat the infection. The quest is on for both a vaccine and a more definitive management protocol to curtail the spread. Researchers and clinicians are also exploring the possibility of using cell therapy for severe cases of COVID-19 with ARDS. Mesenchymal stromal cells are known to have immunomodulatory properties and have previously been used to treat viral infections. This review explores the potential of mesenchymal stromal cells as cell therapy for ARDS.


Subject(s)
COVID-19/epidemiology , COVID-19/surgery , Mesenchymal Stem Cell Transplantation/methods , Pandemics , Respiratory Distress Syndrome/epidemiology , Respiratory Distress Syndrome/surgery , SARS-CoV-2 , Animals , COVID-19/virology , Clinical Trials as Topic , Comorbidity , Humans , Immunomodulation , Mesenchymal Stem Cells/immunology , Respiratory Distress Syndrome/virology , Treatment Outcome
11.
Lancet ; 396(10267): 1979-1993, 2021 12 19.
Article in English | MEDLINE | ID: covidwho-933547

ABSTRACT

BACKGROUND: Older adults (aged ≥70 years) are at increased risk of severe disease and death if they develop COVID-19 and are therefore a priority for immunisation should an efficacious vaccine be developed. Immunogenicity of vaccines is often worse in older adults as a result of immunosenescence. We have reported the immunogenicity of a novel chimpanzee adenovirus-vectored vaccine, ChAdOx1 nCoV-19 (AZD1222), in young adults, and now describe the safety and immunogenicity of this vaccine in a wider range of participants, including adults aged 70 years and older. METHODS: In this report of the phase 2 component of a single-blind, randomised, controlled, phase 2/3 trial (COV002), healthy adults aged 18 years and older were enrolled at two UK clinical research facilities, in an age-escalation manner, into 18-55 years, 56-69 years, and 70 years and older immunogenicity subgroups. Participants were eligible if they did not have severe or uncontrolled medical comorbidities or a high frailty score (if aged ≥65 years). First, participants were recruited to a low-dose cohort, and within each age group, participants were randomly assigned to receive either intramuscular ChAdOx1 nCoV-19 (2·2 × 1010 virus particles) or a control vaccine, MenACWY, using block randomisation and stratified by age and dose group and study site, using the following ratios: in the 18-55 years group, 1:1 to either two doses of ChAdOx1 nCoV-19 or two doses of MenACWY; in the 56-69 years group, 3:1:3:1 to one dose of ChAdOx1 nCoV-19, one dose of MenACWY, two doses of ChAdOx1 nCoV-19, or two doses of MenACWY; and in the 70 years and older, 5:1:5:1 to one dose of ChAdOx1 nCoV-19, one dose of MenACWY, two doses of ChAdOx1 nCoV-19, or two doses of MenACWY. Prime-booster regimens were given 28 days apart. Participants were then recruited to the standard-dose cohort (3·5-6·5 × 1010 virus particles of ChAdOx1 nCoV-19) and the same randomisation procedures were followed, except the 18-55 years group was assigned in a 5:1 ratio to two doses of ChAdOx1 nCoV-19 or two doses of MenACWY. Participants and investigators, but not staff administering the vaccine, were masked to vaccine allocation. The specific objectives of this report were to assess the safety and humoral and cellular immunogenicity of a single-dose and two-dose schedule in adults older than 55 years. Humoral responses at baseline and after each vaccination until 1 year after the booster were assessed using an in-house standardised ELISA, a multiplex immunoassay, and a live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) microneutralisation assay (MNA80). Cellular responses were assessed using an ex-vivo IFN-γ enzyme-linked immunospot assay. The coprimary outcomes of the trial were efficacy, as measured by the number of cases of symptomatic, virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events. Analyses were by group allocation in participants who received the vaccine. Here, we report the preliminary findings on safety, reactogenicity, and cellular and humoral immune responses. This study is ongoing and is registered with ClinicalTrials.gov, NCT04400838, and ISRCTN, 15281137. FINDINGS: Between May 30 and Aug 8, 2020, 560 participants were enrolled: 160 aged 18-55 years (100 assigned to ChAdOx1 nCoV-19, 60 assigned to MenACWY), 160 aged 56-69 years (120 assigned to ChAdOx1 nCoV-19: 40 assigned to MenACWY), and 240 aged 70 years and older (200 assigned to ChAdOx1 nCoV-19: 40 assigned to MenACWY). Seven participants did not receive the boost dose of their assigned two-dose regimen, one participant received the incorrect vaccine, and three were excluded from immunogenicity analyses due to incorrectly labelled samples. 280 (50%) of 552 analysable participants were female. Local and systemic reactions were more common in participants given ChAdOx1 nCoV-19 than in those given the control vaccine, and similar in nature to those previously reported (injection-site pain, feeling feverish, muscle ache, headache), but were less common in older adults (aged ≥56 years) than younger adults. In those receiving two standard doses of ChAdOx1 nCoV-19, after the prime vaccination local reactions were reported in 43 (88%) of 49 participants in the 18-55 years group, 22 (73%) of 30 in the 56-69 years group, and 30 (61%) of 49 in the 70 years and older group, and systemic reactions in 42 (86%) participants in the 18-55 years group, 23 (77%) in the 56-69 years group, and 32 (65%) in the 70 years and older group. As of Oct 26, 2020, 13 serious adverse events occurred during the study period, none of which were considered to be related to either study vaccine. In participants who received two doses of vaccine, median anti-spike SARS-CoV-2 IgG responses 28 days after the boost dose were similar across the three age cohorts (standard-dose groups: 18-55 years, 20 713 arbitrary units [AU]/mL [IQR 13 898-33 550], n=39; 56-69 years, 16 170 AU/mL [10 233-40 353], n=26; and ≥70 years 17 561 AU/mL [9705-37 796], n=47; p=0·68). Neutralising antibody titres after a boost dose were similar across all age groups (median MNA80 at day 42 in the standard-dose groups: 18-55 years, 193 [IQR 113-238], n=39; 56-69 years, 144 [119-347], n=20; and ≥70 years, 161 [73-323], n=47; p=0·40). By 14 days after the boost dose, 208 (>99%) of 209 boosted participants had neutralising antibody responses. T-cell responses peaked at day 14 after a single standard dose of ChAdOx1 nCoV-19 (18-55 years: median 1187 spot-forming cells [SFCs] per million peripheral blood mononuclear cells [IQR 841-2428], n=24; 56-69 years: 797 SFCs [383-1817], n=29; and ≥70 years: 977 SFCs [458-1914], n=48). INTERPRETATION: ChAdOx1 nCoV-19 appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose. Further assessment of the efficacy of this vaccine is warranted in all age groups and individuals with comorbidities. FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midlands NIHR Clinical Research Network, and AstraZeneca.


Subject(s)
COVID-19 Vaccines/administration & dosage , Immunogenicity, Vaccine , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/pharmacology , Female , Humans , Immunization, Secondary/adverse effects , Immunoglobulin G/blood , Immunoglobulin G/drug effects , Male , Middle Aged , SARS-CoV-2/drug effects , Single-Blind Method , Young Adult
12.
Risk Manag Healthc Policy ; 13: 1999-2010, 2020.
Article in English | MEDLINE | ID: covidwho-858664

ABSTRACT

Novel Coronavirus, also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in December 2019 in China and spread rapidly all around the world infecting many people. To date, no specific vaccines and drugs have been developed for this disease. Also, due to the COVID-19 pandemic and high prevalence of the infected patients, the drugs and the therapies of other past viral epidemics have been used for this disease. Many studies have been performed on the specific treatments to find whether or not they are effective on COVID-19 patients. In this review, we collected information about the most widely used drugs to treat COVID-19 (coronavirus disease 2019) belonging to groups of antivirals, antibiotics, immune modulators, and anticoagulants. Some of these compounds and drugs were used directly by inpatients, so researchers have examined others in laboratory conditions. This study considered the pros and cons of using these treatments separately and together and compared their results. By studying this review, we hope to provide useful information for researchers.

13.
Front Public Health ; 8: 554247, 2020.
Article in English | MEDLINE | ID: covidwho-801346

ABSTRACT

Background: Research collaboration of registered clinical trials for Coronavirus Disease 2019 (COVID-19) remains unclear. This study aimed to analyze research collaboration and distribution of outcome measures in registered interventional clinical trials (ICTs) of COVID-19 conducted in China. Methods: The International Clinical Trials Registry Platform, China Clinical Trials Registry, and Clinicaltrials.gov were searched to obtain COVID-19-registered ICTs up to May 25, 2020. Excel 2016 was used to perform a descriptive statistical analysis of the extracted information. VOSviewer 1.6.14 software was used to generate network maps for provinces and institutions and create density maps for outcomes. Results: A total of 390 ICTs were included, and the number of daily registrations fluctuated greatly. From 29 provinces in China, 430 institutions contributed to the registration of ICTs. The top three productive provinces were Hubei (160/390, 41.03%), Shanghai (60/390, 15.38%), and Beijing (59/390, 15.13%). The top three productive institutions were Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology (30/390, 7.69%), Zhongnan Hospital of Wuhan University (18/390, 4.62%), and Wuhan Jinyintan Hospital (18/390, 4.62%). Collaborations between provinces and institutions were not close enough. There were many interventions, but many trials did not provide specific drugs and their dosage and treatment duration. The most frequently used primary outcome was Chest/lung CT (53/390, 13.59%), and the most frequently used secondary outcome was hospital stay (33/390, 8.46%). There was a large difference in the number of outcomes, the expression of some outcomes was not standardized, the measurement time and tools for some outcomes were not clear, and there was a lack of special outcomes for trials of traditional Chinese medicine. Conclusions: Although there were some collaborations between provinces and institutions of the current COVID-19 ICT protocols in China, cooperation between regions should be further strengthened. The identified deficiencies in interventions and outcome measures should be given more attention by future researchers of COVID-19.


Subject(s)
COVID-19 , Beijing , China , Humans , Outcome Assessment, Health Care , SARS-CoV-2
14.
Trials ; 21(1): 481, 2020 Jun 05.
Article in English | MEDLINE | ID: covidwho-548062

ABSTRACT

OBJECTIVES: The objectives of these two separate trials are: (1) to reduce health care workers (HCWs) absenteeism; and (2) to reduce hospital admission among the elderly during the COVID-19 pandemic through BCG vaccination. TRIAL DESIGN: Two separate multi-centre placebo-controlled parallel group randomized trials PARTICIPANTS: (1) Health care personnel working in the hospital or ambulance service where they will take care of patients with the COVID-19 infection and (2) elderly ≥60 years. The HCW trial is being undertaken in 9 hospitals. The elderly trial is being undertaken in locations in the community in Nijmegen, Utrecht, and Veghel, in the Netherlands, using senior citizen organisations to facilitate recruitment. INTERVENTION AND COMPARATOR: For both trials the intervention group will be randomized to vaccination with 0.1 ml of the licensed BCG vaccine (Danish strain 1331, SSI, Denmark, equivalent to 0.075 mg attenuated M. bovis). The placebo group consists of 0.1 ml 0.9% NaCl, which is the same amount, and has the same colour and appearance as the suspended BCG vaccine. MAIN OUTCOMES: (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19. RANDOMISATION: Participants will be randomized to BCG vaccine or placebo (1;1) centrally using a computer- based system, stratified by study centre. BLINDING (MASKING): Subjects, investigators, physicians and outcome assessors are blinded for the intervention. Only the pharmacist assistant that prepares- and research personnel that administers- study medicines are unblinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): (1) The sample size for the first trial is N=1500 HCWs randomised 1:1 to either BCG vaccine (n=750) and placebo (n=750) and (2) The sample size for the second trial is N=1600 elderly persons randomised to BCG vaccine (n=800) and the placebo group (n=800). TRIAL STATUS: HCW: version 4.0, 24-04-2020. Recruitment began 25-03-2020 and was completed on the 23-04-2020. Elderly: version 3.0, 04-04-2020. Recruitment began 16-04- 2020 and is ongoing. TRIAL REGISTRATION: The HCWs trial was registered 31-03-2020 at clinicaltrials.gov (identifier: NCT04328441) and registered 20-03-2020 at the Dutch Trial Registry (trialregister.nl, identifier Trial NL8477). The elderly trial was registered 22-04-2020 at the Dutch trial registry with number NL8547. FULL PROTOCOL: The full protocols will be attached as additional files, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Absenteeism , BCG Vaccine/immunology , Betacoronavirus , Coronavirus Infections/prevention & control , Health Personnel , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Randomized Controlled Trials as Topic , Vaccination , Adult , Aged , Aged, 80 and over , COVID-19 , Female , Hospitalization , Humans , Male , Middle Aged , Multicenter Studies as Topic , SARS-CoV-2
15.
Arch Acad Emerg Med ; 8(1): e45, 2020.
Article in English | MEDLINE | ID: covidwho-100344

ABSTRACT

BACKGROUND: The purpose of the current systematic review is to evaluate the efficacy of antiviral therapies in treatment of COVID-19. In addition, clinical trials on the efficacy of antiviral therapies in the management of Severe Acute Respiratory Syndrome coronavirus (SARS-Cov) or Middle East Respiratory Syndrome coronavirus (MERS-CoV) have also been reviewed, in order to identify potential treatment options for COVID-19. METHOD: An extensive search was performed in Medline, Embase, Scopus, Web of Science and CENTRAL databases until the end of March 15, 2020. Two independent researchers performed the screening, and finally the related studies were included. RESULTS: Only one clinical trial on the efficacy of antiviral therapy in management of COVID-19 was found. The results depicted that adding Lopinavir-Ritonavir to the standard treatment regimen of patients with severe COVID-19 has no benefits. Moreover, 21 case-series and case-report studies reported the prescription of antiviral agents in COVID-19, none of which can be used to determine the efficacy of antiviral therapies in confronting COVID-19. In addition, no clinical trials were found to be performed on the efficacy of antiviral agents in the management of SARS-CoV and MERS-CoV. CONCLUSION: The current evidence impede researchers from proposing an appropriate antiviral therapy against COVID-19, making the current situation a serious concern for international organizations such as World Health Organization (WHO). In the time of the current pandemic and future epidemics, organizations such as WHO should pursue more proactive actions and plan well-designed clinical trials so that their results can be used in managing future epidemics.

16.
Curr Cardiol Rep ; 22(5): 31, 2020 04 14.
Article in English | MEDLINE | ID: covidwho-46694

ABSTRACT

PURPOSE OF REVIEW: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus responsible for the aggressive coronavirus disease (COVID-19) pandemic. Recently, investigators have stipulated that COVID-19 patients receiving angiotensin-converting-enzyme inhibitors (ACEI) may be subject to poorer outcomes. This editorial presents the available evidence to guide treatment practices during this pandemic. RECENT FINDINGS: Recent studies from Wuhan cohorts provide valuable information about COVID-19. A cohort with 52 critically ill patients revealed cardiac injury in 12% of patients. Worse outcomes appear to be more prevalent in patients with hypertension and diabetes mellitus (DM), possibly due to overexpression of angiotensin-converting enzyme 2 (ACE2) receptor in airway alveolar epithelial cells. Investigators suspect that SARS-CoV-2 uses the ACE2 receptor to enter the lungs in a mechanism similar to SARS-CoV. Several hypotheses have been proposed to date regarding the net effect of ACEI/ARB on COVID-19 infections. Positive effects include ACE2 receptor blockade, disabling viral entry into the heart and lungs, and an overall decrease in inflammation secondary to ACEI/ARB. Negative effects include a possible retrograde feedback mechanism, by which ACE2 receptors are upregulated. Even though physiological models of SARS-CoV infection show a theoretical benefit of ACEI/ARB, these findings cannot be extrapolated to SARS-CoV-2 causing COVID-19. Major cardiology scientific associations, including ACC, HFSA, AHA, and ESC Hypertension Council, have rejected these correlation hypotheses. After an extensive literature review, we conclude that there is no significant evidence to support an association for now, but given the rapid evolvement of this pandemic, findings may change.


Subject(s)
Alveolar Epithelial Cells/metabolism , Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , Coronavirus Infections/drug therapy , Coronavirus/isolation & purification , Pneumonia, Viral/drug therapy , Practice Guidelines as Topic , Angiotensin Receptor Antagonists/adverse effects , Angiotensin-Converting Enzyme 2 , Angiotensin-Converting Enzyme Inhibitors/adverse effects , Betacoronavirus , COVID-19 , Comorbidity , Coronavirus/drug effects , Coronavirus Infections/epidemiology , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/epidemiology , Humans , Hypertension/complications , Hypertension/epidemiology , Pandemics , Peptidyl-Dipeptidase A/adverse effects , Peptidyl-Dipeptidase A/therapeutic use , Pneumonia, Viral/epidemiology , SARS-CoV-2
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