scholarly journals How robust are the results of one of the first positive trials exploring hydroxychloroquine for treatment of COVID-19?

2020 ◽  
Author(s):  
Ronald Chow ◽  
Sameer Elsayed ◽  
Michael Lock
Keyword(s):  
Antiviral Agents ◽  
World Health ◽  
Rt Pcr ◽  
Open Label ◽  
Study Results ◽  
Minimum Number ◽  
Potential Activity ◽  
Coronavirus Infection ◽  
Open Label Trial ◽  
Health Organization

AbstractAn outbreak of a novel human coronavirus infection emerged in Wuhan, China in December 2019. Two months later, the World Health Organization (WHO) announced SARS-CoV-2 as the name for the new virus and COVID-19 for the associated illness. On March 12, 2020, the WHO officially declared COVID-19 as a pandemic. The scientific community has raced to find effective therapeutic agents against the virus. Gautret et al 2020 is among one of the first purportedly positive trials of hydroxychloroquine for the treatment of COVID-19. However, it is imperative that a thorough analysis and understanding of trial data be undertaken prior to making claims about safety and efficacy. Our group assessed the statistical robustness of the trial using the Fragility Index (FI). The FI provides a numerical quantification of a clinical trial’s conclusions. The index is based on iterative statistical calculations to determine the minimum number of events within a trial that would theoretically need to change from positive to negative in order for the trial’s endpoint to convert from significant to non-significant; the higher the index, the more statistically robust the study results. For the Gautret et al trial, one endpoint had an FI of 1, two had indices of 2, and another had an index of 4. The primary endpoint of viral clearance on day 6 had an FI of 4. This indicates that if 4 events were to change from positive to negative, the conclusion of the trial would become mathematically non-significant. This index is comparable to many other published trials of established agents; the median FI across the reported literature appears to be 2. In conclusion, the trial results reported by Gautret et al are statistically robust, assuming that data quality is not compromised; however, the study was an open-label trial with non-homogenous groups, with analysis conducted per-protocol. Additionally, SARS-CoV-2 Reverse Transcriptase-PCR (RT-PCR) testing was not conducted in a systematic way amongst the two groups. Further analyses of this trial and future trials of antiviral agents with potential activity against SARS-CoV-2 should be performed with complementary epidemiologic and statistical techniques to determine whether the trial’s results are clinically important and/or should be explored in depth. Given the statistically robust results reported by Gautret et al, despite the study’s inherent methodological and analytical flaws, hydroxychloroquine should be studied as a potential agent against COVID-19 in larger clinical trials.

scholarly journals Multisystem inflammatory syndrome in children - a clinical example in pediatrics

2021 ◽  
Vol 25 (2) ◽  
pp. 258-260
Author(s):  
V. M. Dudnyk ◽  
V. Н. Furman ◽  
I. I. Andrikevych ◽  
N. O. Buglova ◽  
O. V. Кutsak ◽  
...  
Keyword(s):  
Serological Test ◽  
World Health ◽  
Rt Pcr ◽  
The Us ◽  
Control And Prevention ◽  
Coronavirus Infection ◽  
Polymerase Chain ◽  
Health Organization ◽  
Inflammatory Syndrome

Annotation. Peculiarities of clinical course and differential diagnosis of multisystem inflammatory syndrome (MIS-C) in children with coronavirus infection are described. The main features of this disease are long-term fever, multiorgan dysfunction, laboratory signs of inflammation and positive tests for SARS-CoV-2 (polymerase chain reaction using reverse transcription (RT-PCR), antigen test or positive serological test). The criteria of the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC) are used to confirm the MIS-C diagnosis.

Screening for active tuberculosis before isoniazid preventive therapy among HIV-infected West African adults

2017 ◽  
Vol 21 (12) ◽  
pp. 1237-1244 ◽  
Author(s):  
R. Moh ◽  
A. Badjé ◽  
J-B. N'takpé ◽  
G. M. Kouamé ◽  
D. Gabillard ◽  
...  
Keyword(s):  
Preventive Therapy ◽  
Isoniazid Preventive Therapy ◽  
World Health ◽  
Open Label ◽  
Clinical Algorithm ◽  
Related Risk ◽  
Immunodeficiency Virus ◽  
Chest X Ray ◽  
Open Label Trial ◽  
Health Organization

SETTING: TEMPRANO was a multicentre, open-label trial in which human immunodeficiency virus (HIV) infected adults with high CD4 counts were randomised into early or deferred antiretroviral therapy (ART) arms with or without 6-month isoniazid preventive therapy (IPT) in a setting where the World Health Organization (WHO) recommends IPT in HIV-infected patients. Despite the WHO recommendation, IPT coverage remains low due to fear of the presence of undiagnosed active TB before prescribing IPT, and the related risk of drug resistance.OBJECTIVE: To report the frequency of undiagnosed TB in patients enrolled for IPT and describe the results of a 1-month buffer period to avoid prescribing IPT for active TB cases.DESIGN: Patients were screened using a clinical algorithm and chest X-ray at Day 0 and started on isoniazid at Month 1 if no sign/symptom suggestive of TB appeared between Day 0 and Month 1.RESULTS: Of 1030 patients randomised into IPT arms. 10% never started IPT at Month 1. Of these, 23 had active TB, including 16 with prevalent TB. Among the 927 patients who started IPT, 6 had active TB, including 1 with prevalent TB. Only 1 patient with active TB received IPT due to the 1-month buffer period between Day 0 and IPT initiation.CONCLUSION: In this study, 1.6% of adults considered free of active TB based on clinical screening at pre-inclusion actually had active TB.

RT-PCR Status and Antibody Response in Patients with Coronavirus Disease 2019

2020 ◽  
Author(s):  
Lan Chen ◽  
Xiao-Bin Zhang ◽  
Zhen-Yu Zhang ◽  
Su-Zhen Zhang ◽  
Qiu-Ying Han ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Peak Level ◽  
World Health ◽  
Rt Pcr ◽  
Igg Antibody ◽  
Open Label ◽  
Potential Biomarker ◽  
Novel Coronavirus ◽  
Health Organization ◽  
High Level

Abstract Background: Novel coronavirus (COVID-19) is a new viral species that causes pneumonia. Currently, RT-PCR and IgM/IgG antibody assays have been recommended for the diagnosis of COVID-19 infection. However, the correlation between RT-PCR status and antibody (IgG, IgM) response remains unknown. Methods: Consecutive COVID-19 patients admitted to our department between February 10, 2020 and March 10, 2020, were diagnosed by guidelines issued by the World Health Organization (WHO) and included in this study. RT-PCR and antibody (IgM/IgG) assays for COVID-19 infection were performed for all patients according to the manufactures’ protocols. Other data, such as demographic, clinical, laboratory, as well as treatment and outcome, were collected using data collection tables from electronic medical records.Results: During the study period, a total of 103 patients were diagnosed as having a moderate type of COVID-19 at our department, including 55 males and 48 females, with an average age of 57.53 ± 1.65 years old (range 23 to 90 years old). The peak level of SARS-CoV-2 IgM antibody (243.10 ± 89.84 AU/ml) was reported 4 days after the negative RT-PCR (-) (all P < 0.05). Subsequently, the IgM decreased to 42.69 ± 22.39 AU/ml 21 days after RT-PCR (-). However, the IgG was maintained at a high level 4 days before RT-PCR (-) and later. The lymphocyte count was at the lowest level on day7 before the RT-PCR(-) result (P<0.05), and then elevated after RT-PCR conversion (viral clearance).Conclusions: SARS-CoV-2 IgM/IgG levels did not correlate with RT-PCR status in our study sample. We found that SARS-CoV-2 IgM/IgG could be a potential biomarker to monitor clinical course, determine discharge, and assess recovery of those infected patients with the novel coronavirus. Trial registration: A prospective, open label, randomized, control trial for chloroquine or hydroxychloroquine in patients with mild and common novel coronavirus pulmonary (COVIP-19). ChiCTR2000030054. Registered 18 Feb,2020. http://www.chictr.org.cn/edit.aspx?pid=49869&htm=4

scholarly journals An evidence-based systematic review on emerging therapeutic and preventive strategies to treat novel coronavirus (SARS-CoV-2) during an outbreak scenario

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Anupama M. Gudadappanavar ◽  
Jyoti Benni
Keyword(s):  
Antiviral Drug ◽  
Drug Repurposing ◽  
Respiratory Illness ◽  
World Health ◽  
Recombinant Vaccines ◽  
Subunit Vaccines ◽  
Coronavirus Infection ◽  
Novel Coronavirus ◽  
Health Organization ◽  
Full Length Genome

AbstractA novel coronavirus infection coronavirus disease 2019 (COVID-19) emerged from Wuhan, Hubei Province of China, in December 2019 caused by SARS-CoV-2 is believed to be originated from bats in the local wet markets. Later, animal to human and human-to-human transmission of the virus began and resulting in widespread respiratory illness worldwide to around more than 180 countries. The World Health Organization declared this disease as a pandemic in March 2020. There is no clinically approved antiviral drug or vaccine available to be used against COVID-19. Nevertheless, few broad-spectrum antiviral drugs have been studied against COVID-19 in clinical trials with clinical recovery. In the current review, we summarize the morphology and pathogenesis of COVID-19 infection. A strong rational groundwork was made keeping the focus on current development of therapeutic agents and vaccines for SARS-CoV-2. Among the proposed therapeutic regimen, hydroxychloroquine, chloroquine, remdisevir, azithromycin, toclizumab and cromostat mesylate have shown promising results, and limited benefit was seen with lopinavir–ritonavir treatment in hospitalized adult patients with severe COVID-19. Early development of SARS-CoV-2 vaccine started based on the full-length genome analysis of severe acute respiratory syndrome coronavirus. Several subunit vaccines, peptides, nucleic acids, plant-derived, recombinant vaccines are under pipeline. This article concludes and highlights ongoing advances in drug repurposing, therapeutics and vaccines to counter COVID-19, which collectively could enable efforts to halt the pandemic virus infection.

scholarly journals Occupational health risk among healthcare workers during COVID-19 pandemic: actions to limit the risk

2021 ◽  
Vol 96 (1) ◽  
Author(s):  
Eman Casper
Keyword(s):  
Occupational Health ◽  
Health Risk ◽  
Healthcare Workers ◽  
World Health ◽  
High Morbidity ◽  
Wuhan City ◽  
Coronavirus Infection ◽  
Health Organization ◽  
Respiratory Droplets ◽  
Very High

AbstractThe World Health Organization declared coronavirus infection 2019 (COVID-19) as a pandemic in March 2020. The infection with coronavirus started in Wuhan city, China, in December 2019. As of October 2020, the disease was reported in 235 countries. The coronavirus infection 2019 (COVID-19) is a disease with high morbidity and mortality. As of February 2021, the number of confirmed cases of COVID-19 globally is 102,942,987 and 2,232,233 deaths according to WHO report. This infection is caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), which is a ribonucleic acid (RNA) β-coronavirus. The infection is mainly transmitted through respiratory droplets.Healthcare workers (HCWs) play an essential role at the front lines, providing care for patients infected with this highly transmittable disease. They are exposed to very high occupational health risk as they frequently contact the infective persons. In order to limit the number of infected cases and deaths among healthcare workers, it is crucial to have better awareness, optimistic attitude, efficient PPE, and adequate health practices about COVID-19.

scholarly journals The health effects of quarantine during the COVID-19 pandemic

Work ◽  
2020 ◽  
Vol 67 (3) ◽  
pp. 523-527
Author(s):  
Maryam Feiz Arefi ◽  
Amin Babaei-Pouya ◽  
Mohsen Poursadeqiyan
Keyword(s):  
Health Effects ◽  
World Health ◽  
Economic Activities ◽  
Negative Effects ◽  
Social Hygiene ◽  
Social Communications ◽  
Study Results ◽  
Control And Prevention ◽  
Health Organization ◽  
Made In

BACKGROUND: Quarantine is considered as an effective solution in the early stages of an epidemic. In the case of the coronavirus epidemic, quarantine was also recommended and implemented as a significant guideline to prevent the disease. However, despite the benefits of quarantine, there are also complications and problems. OBJECTIVE: The present study aimed to investigate the health effects of quarantine during the COVID-19 pandemic. METHODS: This study was conducted as a literature review through searching the databases Google Scholar, PubMed, and Science Direct for papers published before July 2020. The research was conducted based on the keywords “Coronavirus,” “COVID-19,” and “quarantine.” The references of the papers were also reviewed to find the ones not found in the databases. The guidelines published by reputable organizations such as the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) were used in this study. RESULTS: Although quarantine is applied as an important and primary solution in the outbreak of epidemics, in cases of pandemics, it may not be free of negative effects on individuals and public health. However, because of the need to reopen and restart social and economic activities, some changes should be made in lifestyles and work activities. Using cyberspace and telework can be helpful. As the findings showed, COVID-19 bubbles can be used to restore social communications. CONCLUSION: Using masks, avoiding unnecessary gatherings, complying with personal and social hygiene, and respecting social distancing can be valuable solutions that, if implemented properly, can decrease the rate of the disease significantly. It is also emphasized that quarantine is still necessary and important as the best solution for sick people and individuals who are suspected carriers of the disease.

scholarly journals Immunochromatographic assays for COVID-19 epidemiological screening: our experience

2020 ◽  
Author(s):  
Andrea Bartolini ◽  
Margherita Scapaticci ◽  
Marina Bioli ◽  
Tiziana Lazzarotto ◽  
Maria Carla Re ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
World Health ◽  
Rt Pcr ◽  
Serological Screening ◽  
Rapid Assays ◽  
In Vitro Diagnostic ◽  
Biomedical Prevention ◽  
Health Organization ◽  
Performance Validation

In March 2020, the World Health Organization (WHO) declared a pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Due to the absence of effective treatment or biomedical prevention, understanding potential post infection immunity has important implications for epidemiologic assessments. For this reason, increasing number of in vitro diagnostic companies are developing serological assays to detect antibodies against SARS-CoV-2, but most of them lack the validation by third parties in relation to their quality, limiting their usefulness. We submitted to serological screening by two different immunochromatographic (IC) rapid testing for detection of IgG and IgM against SARS-CoV-2, 151 asymptomatic or minimally symptomatic healthcare workers previously tested positive for SARS-CoV-2 RT-PCR in order to evaluate the performance of rapid assays. Results showed discrepancies between molecular and IC results, and an inconsistency of immunoglobulins positivity patterns when compared to ELISA/CLIA results, highlighting the absolute necessity of assays performance validation before their marketing and use, in order to avoid errors in the results evaluation at both clinical and epidemiological level.

scholarly journals Novel Antiviral Activities of Obatoclax, Emetine, Niclosamide, Brequinar, and Homoharringtonine

2019 ◽  
Author(s):  
Petter I. Andersen ◽  
Klara Krpina ◽  
Aleksandr Ianevski ◽  
Nastassia Shtaida ◽  
Eunji Jo ◽  
...  
Keyword(s):  
Influenza A ◽  
Rift Valley Fever Virus ◽  
Antiviral Agents ◽  
Viral Disease ◽  
World Health ◽  
Valley Fever ◽  
The World ◽  
Health Organization ◽  
Hiv 1

Viruses are the major causes of acute and chronic infectious diseases in the world. According to the World Health Organization, there is an urgent need for better control of viral diseases. Re-purposing existing antiviral agents from one viral disease to another could play a pivotal role in this process. Here we identified novel activities of obatoclax and emetine against herpes simplex virus type 2 (HSV-2), human immunodeficiency virus 1 (HIV-1), echovirus 1 (EV1), human metapneumovirus (HMPV) and Rift Valley fever virus (RVFV) in cell cultures. Moreover, we demonstrated novel activities of emetine against influenza A virus (FluAV), niclosamide against HSV-2, brequinar against HIV-1, and homoharringtonine against EV1. Our findings may expand the spectrum of indications of these safe-in-man agents and reinforce the arsenal of available antiviral therapeutics pending the results of further in vivo tests.

scholarly journals Drug use as a coping style to social isolation by COVID-19 pandemic and its effects on the adherence to safety guidelines in Mexico

2021 ◽  
Vol 7 (1) ◽  
pp. 25-32
Author(s):  
Diana Mejía ◽  
Alejandro Gutierrez-Trejo ◽  
Laurent Avila-Chauvet ◽  
Lynette Bonin
Keyword(s):  
Drug Use ◽  
Social Isolation ◽  
World Health ◽  
Safety Behavior ◽  
Study Results ◽  
Stress Experience ◽  
Behavior Scale ◽  
Health Organization ◽  
The Relationship ◽  
Safety Guidelines

Introduction: in response to the pandemic originated by COVID-19, governments placed in practice a series of safety guidelines recommended by the World Health Organization (WHO). In Mexico, one of the decisive actions to prevent the disease's spread was social isolation or lockdown. These rigorous proceedings could increase stress experience or other mental health disorders. One of the coping mechanisms used to avoid stress includes drug use. Objective: the study's goal was to evaluate the relationship between drug use (alcohol, tobacco, and cannabis) and adherence to safety guidelines. Method: the association between the variables was assessed with a series of surveys indicating adherence to safety guidelines and drug use, 475 Mexican participants (56.5% females and 43.4% males) completed the study. Results: the results suggest that most participants had low drug abuse levels before and during social isolation. There was a significant decrease in tobacco, alcohol, and cannabis use in both females and males. Upon analyzing guideline adherence, low alcohol use correlated with the safety behavior scale, while tobacco and cannabis correlated with the preventive behavior scale. Discussion: the current Mexican sample had not used drugs to cope during social isolation.

scholarly journals Development and Validation of Emotion Regulation Strategies in Germophobia Questionnaire in Iran

2020 ◽  
Vol 8 (4) ◽  
pp. 307-316
Author(s):  
Seyed Mohammadreza Alavizadeh ◽  
◽  
Mojgan Sepahmansour ◽  
Somaye Entezari ◽  
Mohammadreza Seirafi ◽  
...  
Keyword(s):  
Emotion Regulation ◽  
World Health ◽  
Snowball Sampling ◽  
Emotion Regulation Strategies ◽  
Study Results ◽  
The World ◽  
Valid Instrument ◽  
Regulation Strategies ◽  
Health Organization ◽  
Study Participants

Objective: The Coronavirus Disease-2019 (COVID-19) has recently been identified as a pandemic by the World Health Organization. The outbreak of the disease has caused numerous individuals around the world to become extremely frightened and subsequently present the signs of phobia. Fear is the basic emotion of anxiety disorders and individuals cope with their emotions by different strategies. The present study aimed at developing and validating Emotion Regulation Strategies for Germophobia Questionnaire (ERS-GPQ). Methods: The study participants were 99 individuals (74 females) of the Iranian population with concerns about germs who were selected with the snowball sampling method. They completed the ERS-GPQ and GPQ in the Google Forms platform. Results: The present study results illustrated that the ERS-GPQ has acceptable internal consistency with Cronbach’s alpha coefficient (a=0.61), reliability coefficients with split-half (0.70), and one-week test-retest (0.92); the ERS-GPQ also presented a moderate positive correlation with the contamination obsessions checklist of GPQ (r=0.44) as the convergent coefficient. Besides, the confirmatory factor analysis indicated 2 factors of the ERS-GPQ. Finally, the ERS-GPQ has 2 components with good convergent and discriminate validities and composite reliability. Conclusion: Based on the current research findings, the ERS-GPQ has acceptable and good psychometric properties; researchers can use the ERS-GPQ as a reliable and valid instrument for assessing ER strategies concerning germophobia. Furthermore, it has some considerations for practitioners in epidemic and pandemic crises, like COVID-19.

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