scholarly journals Therapeutic Application of Chloroquine and Hydroxychloroquine in Clinical Trials for COVID-19: A systematic review

2020 ◽  
Author(s):  
Divya RSJB Rana ◽  
Santosh Dulal
Keyword(s):  
Public Health ◽  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Virus Disease ◽  
Global Public Health ◽  
Therapeutic Application ◽  
Clinical Trial Registries ◽  
Corona Virus

AbstractThe corona virus disease -2019 (COVID-19) pandemic has caused a massive global public health havoc. Recent published clinical trials show conflicting data for use of chloroquine/hydroxychloroquine for COVID-19. This study meticulously evaluated the various dosages of chloroquine and hydroxychloroquine utilized in clinical trials registered in Chinese and US clinical trial registries for the treatment of pneumonia caused by SARS-CoV-2. Moreover, the results of published clinical trials and in vitro studies using chloroquine and hydroxychloroquine relevant to the disease are discussed.

scholarly journals Rare use of patient-reported outcomes in childhood cancer clinical trials – a systematic review of clinical trial registries

2021 ◽  
Vol 152 ◽  
pp. 90-99
Author(s):  
David Riedl ◽  
Maria Rothmund ◽  
Anne-Sophie Darlington ◽  
Samantha Sodergren ◽  
Roman Crazzolara ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Childhood Cancer ◽  
Patient Reported Outcomes ◽  
Cancer Clinical Trials ◽  
Clinical Trial Registries ◽  
Patient Reported

scholarly journals Recent Updates in Experimental Research and Clinical Evaluation on Drugs for COVID-19 Treatment

2021 ◽  
Vol 12 ◽  
Author(s):  
Houwen Zou ◽  
Yuqi Yang ◽  
Huiqiang Dai ◽  
Yunchuang Xiong ◽  
Jing-Quan Wang ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Experimental Research ◽  
Clinical Evaluation ◽  
Clinical Studies ◽  
Virus Disease ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Global Public Health ◽  
The World

Since the outbreak of corona virus disease 2019 (COVID-19) in Wuhan (China) in December 2019, the epidemic has rapidly spread to many countries around the world, posing a huge threat to global public health. In response to the pandemic, a number of clinical studies have been initiated to evaluate the effect of various treatments against COVID-19, combining medical strategies and clinical trial data from around the globe. Herein, we summarize the clinical evaluation about the drugs mentioned in this review for COVID-19 treatment. This review discusses the recent data regarding the efficacy of various treatments in COVID-19 patients, to control and prevent the outbreak.

COVID – 19 and Gravid Mothers

2020 ◽  
Vol 11 (SPL1) ◽  
pp. 1171-1174
Author(s):  
Shruti Sadavarte ◽  
Bhagyashri Vijay Chaudhari
Keyword(s):  
Public Health ◽  
World Health Organization ◽  
Virus Disease ◽  
Fetal Distress ◽  
Relevant Information ◽  
Perinatal Transmission ◽  
World Health ◽  
Global Public Health ◽  
Corona Virus ◽  
Health Organization

Human history is observing a very horrible and strange situation fighting a very small enemy. The Novel COVID-19 corona virus. On 11 feb 2020 world health organization has declared a name for covid disorder and has said covid as a global public health diease and also as a pandemic due to its worldwide spread. It started as an outbreak in december with its birth place in wuhan people of china has came out as a global public health exigency of worldwide trouble. Corona virus are the group of virus with non segmented, single stranded and positive sence RNA genome. In this narrative review article, reference was taken from different article published in various database. Maximum article including the information of pregnancy and covid-19 were reviewed. A review of 11article with world health organization site information it is found that the symptoms of corona virus disease in non-pregnant occurred indistinguishable to that of gravid mother. There is no information regarding perinatal transmission in parturiency. It has been disclosed that corona virus can cause distress in gravid mother, miscarriage and also fetal distress. In general due to lack of relevant information regarding the effect of corona virus disease on gravidity it is obligatory to have more and more studies in this area.

The Analysis of Global COVID-19 Clinical Trials Registries

2021 ◽  
Vol 104 (5) ◽  
pp. 825-833
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Real World ◽  
Virus Disease ◽  
Healthcare Personnel ◽  
Controlled Trials ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Clinical Trial Registries ◽  
Population Type

Background: Corona Virus Disease 2019 (COVID-19) is a pandemic-associated health emergency. Multiple preventive strategies have been implemented to try to prevent its transmission, and no drugs have proven to be highly effective yet. There are many ongoing clinical studies of COVID-19 and the information is scattered in each country’s own database. Objective: To provide the insight of the ongoing COVID-19 studies and present the database information to researchers. Healthcare provider can follow these COVID-19 studies and prepare for the upcoming second wave. Materials and Methods: The authors’ searched all COVID-19 studies that were listed in clinical trial registries worldwide and extracted information from each study. The authors’ reported these studies including study population, type of study, country of origin, treatment assigned in controlled clinical trials, and matched the date of registration to the real-world cases. Results: Two thousand nine hundred forty-nine studies from 18 registries were found. Over 2,000 (2,224) studies (75.4%) targeted symptomatic COVID-19 patients, 387 studies (13.1%) targeted non-infected general population, and 237 studies (8.1%) included healthcare personnel. Clinical controlled trials were found in 1,491 studies (50.6%) and 1,346 studies (45.6%) were observational studies. ClinicalTrials.gov was the most prevalent registry, followed by Chinese Clinical Trial Registry (ChiCTR). China also had the highest number of registered trials. Antimalarials and antivirals were the most frequently used treatments in the controlled trials. The number of trials registered increased in parallel to the total number of real-world cases. Conclusion: The number of ongoing COVID-19 clinical trials are steadily increasing. The present study provides an overview of registered studies from worldwide databases, which researchers can use to plan and conduct future studies. Keywords: COVID-19, Clinical trial registry, Global trend

scholarly journals Review of Current Evidence of Hydroxychloroquine in Pharmacotherapy of COVID-19

2020 ◽  
Author(s):  
Umesh Devappa Suranagi ◽  
Harmeet Singh Rehan ◽  
Nitesh Goyal
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
In Vitro Study ◽  
Human Studies ◽  
Current Evidence ◽  
Viral Inhibition ◽  
Open Label ◽  
Clinical Trial Registries ◽  
The World

ABSTRACTImportanceThe COVID-19 Pandemic has literally left the world breathless in the chase for pharmacotherapy. With vaccine and novel drug development in early clinical trials, repurposing of existing drugs takes the center stage.ObjectiveA potential drug discussed in global scientific community is hydroxychloroquine. We intend to systematically explore, analyze, rate the existing evidence of hydroxychloroquine in the light of published, unpublished and clinical trial data.Evidence reviewPubMed Ovid MEDLINE, EMBASE, Google scholar databases, pre-proof article repositories, clinical trial registries were comprehensively searched with focused question of use of hydroxychloroquine in COVID-19 patients. The literature was systematically explored as per PRISMA guidelines.FindingsTotal 139 articles were available as of 25th April 2020; of which 10 articles of relevance were analyzed. Three in-vitro studies were reviewed. Two open label non-randomized trials, two open label randomized control trials, one follow-up study and two retrospective cohort studies were systematically analyzed and rated by oxford CEBM and GRADE framework for quality and strength of evidence. Also 27 clinical trials registered in three clinical trial registries were analyzed and summarized. Hydroxychloroquine seems to be efficient in inhibiting SARS-CoV-2 in in-vitro cell lines. However, there is lack of strong evidence from human studies. It was found that overall quality of available evidence ranges from ‘very low’ to ‘low’.Conclusions and relevanceThe in-vitro cell culture based data of viral inhibition does not suffice for the use of hydroxychloroquine in the patients with COVID-19. Current literature shows inadequate, low level evidence in human studies. Scarcity of safety and efficacy data warrants medical communities, health care agencies and governments across the world against the widespread use of hydroxychloroquine in COVID-19 prophylaxis and treatment, until robust evidence becomes available.KEY POINTSQuestionWhat is the current evidence for use of Hydroxychloroquine in pharmacotherapy of COVID-19?FindingsWe electronically explored various databases and clinical trial registries and identified 10 publications and 27 clinical trials with active recruitment. The in-vitro study data demonstrates the viral inhibition by hydroxychloroquine. The clinical studies are weakly designed and conducted with insufficient reporting and significant limitations. Well designed robust clinical trials are being conducted all over the world and results of few such robust studies are expected shortly.MeaningCurrent evidence stands inadequate to support the use of hydroxychloroquine in pharmacotherapy of COVID-19.

Repurposed Antiviral Drugs for the Treatment of COVID-19: Syntheses, Mechanism of Infection and Clinical Trials

2020 ◽  
Vol 21 ◽  
Author(s):  
Subha Sankar Paul ◽  
Goutam Biswas
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Small Molecule ◽  
Mode Of Action ◽  
Antiviral Drugs ◽  
Public Health Emergency ◽  
Advanced Stage ◽  
Clinical Trial Results

: COVID-19 is a public health emergency of international concern. Although, considerable knowledge has been acquired with time about the viral mechanism of infection and mode of replication, yet no specific drugs or vaccines have been discovered against SARS-CoV-2, till date. There are few small molecule antiviral drugs like Remdesivir and Favipiravir which have shown promising results in different advanced stage of clinical trials. Chloroquinine, Hydroxychloroquine, and Lopinavir-Ritonavir combination, although initially was hypothesized to be effective against SARS-CoV-2, are now discontinued from the solidarity clinical trials. This review provides a brief description of their chemical syntheses along with their mode of action and clinical trial results available in Google and different peer reviewed journals till 24th October 2020.

scholarly journals Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review

BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Asger S. Paludan-Müller ◽  
Perrine Créquit ◽  
Isabelle Boutron
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Study ◽  
Primary Source ◽  
European Medicines Agency ◽  
Clinical Trial Registries ◽  
Number Of Patients ◽  
Journal Publications ◽  
Clinical Study Reports ◽  
Completeness Of Reporting

Abstract Background An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm data reported, and the delay to access results of oncological clinical trials between three sources: clinical study reports (CSRs), clinical trial registries and journal publications. Methods We used the EMA clinical data website to identify all trials submitted to the EMA between 2015 and 2018. We retrieved all CSRs and included all phase II, II/III or III randomised controlled trials (RCTs) assessing targeted therapy and immunotherapy for cancer. We then identified related records in clinical trial registries and journals. We extracted harms data for eight pre-specified variables and determined the completeness of reporting of harm data in each of the three sources. Results We identified 42 RCTs evaluating 13 different drugs. Results were available on the EMA website in CSRs for 37 (88%) RCTs, ClinicalTrials.gov for 36 (86%), the European Clinical Trials Register (EUCTR) for 20 (48%) and in journal publications for 32 (76%). Harms reporting was more complete in CSRs than other sources. We identified marked discrepancies in harms data between sources, e.g. the number of patients discontinuing due to adverse events differed in CSRs and clinical trial registers for 88% of trials with data in both sources. For CSRs and publications, the corresponding number was 90%. The median (interquartile range) delay between the primary trial completion date and access to results was 4.34 (3.09–7.22) years for CSRs, 2.94 (1.16–4.52) years for ClinicalTrials.gov, 5.39 (4.18–7.33) years for EUCTR and 2.15 (0.64–5.04) years for publications. Conclusions Harms of recently approved oncological drugs were reported more frequently and in more detail in CSRs than in trial registries and journal publications. Systematic reviews seeking to address harms of oncological treatments should ideally use CSRs as the primary source of data; however, due to problems with access, this is currently not feasible.

scholarly journals Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis

BMJ ◽  
2018 ◽  
pp. k4738 ◽  
Author(s):  
Joanna C Crocker ◽  
Ignacio Ricci-Cabello ◽  
Adwoa Parker ◽  
Jennifer A Hirst ◽  
Alan Chant ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Lived Experience ◽  
Odds Ratio ◽  
Public Involvement ◽  
Meta Analysis ◽  
Patient And Public Involvement ◽  
Retention Rates ◽  
The Impact

AbstractObjectiveTo investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.DesignSystematic review and meta-analysis.Data sourcesTen electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteriaExperimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysisTwo independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14v1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis).ConclusionsThese findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registrationPROSPERO CRD42016043808.

scholarly journals MERS-CoV Accessory ORFs Play Key Role for Infection and Pathogenesis

mBio ◽  
2017 ◽  
Vol 8 (4) ◽  
Author(s):  
Vineet D. Menachery ◽  
Hugh D. Mitchell ◽  
Adam S. Cockrell ◽  
Lisa E. Gralinski ◽  
Boyd L. Yount ◽  
...  
Keyword(s):  
Public Health ◽  
Viral Replication ◽  
Rapid Response ◽  
Mutant Virus ◽  
Global Public Health ◽  
Vaccine Platform ◽  
Zoonotic Pathogens ◽  
Related Group

ABSTRACT While dispensable for viral replication, coronavirus (CoV) accessory open reading frame (ORF) proteins often play critical roles during infection and pathogenesis. Utilizing a previously generated mutant, we demonstrate that the absence of all four Middle East respiratory syndrome CoV (MERS-CoV) accessory ORFs (deletion of ORF3, -4a, -4b, and -5 [dORF3-5]) has major implications for viral replication and pathogenesis. Importantly, attenuation of the dORF3-5 mutant is primarily driven by dysregulated host responses, including disrupted cell processes, augmented interferon (IFN) pathway activation, and robust inflammation. In vitro replication attenuation also extends to in vivo models, allowing use of dORF3-5 as a live attenuated vaccine platform. Finally, examination of ORF5 implicates a partial role in modulation of NF-κB-mediated inflammation. Together, the results demonstrate the importance of MERS-CoV accessory ORFs for pathogenesis and highlight them as potential targets for surveillance and therapeutic treatments moving forward. IMPORTANCE The initial emergence and periodic outbreaks of MERS-CoV highlight a continuing threat posed by zoonotic pathogens to global public health. In these studies, mutant virus generation demonstrates the necessity of accessory ORFs in regard to MERS-CoV infection and pathogenesis. With this in mind, accessory ORF functions can be targeted for both therapeutic and vaccine treatments in response to MERS-CoV and related group 2C coronaviruses. In addition, disruption of accessory ORFs in parallel may offer a rapid response platform to attenuation of future emergent strains based on both SARS- and MERS-CoV accessory ORF mutants. IMPORTANCE The initial emergence and periodic outbreaks of MERS-CoV highlight a continuing threat posed by zoonotic pathogens to global public health. In these studies, mutant virus generation demonstrates the necessity of accessory ORFs in regard to MERS-CoV infection and pathogenesis. With this in mind, accessory ORF functions can be targeted for both therapeutic and vaccine treatments in response to MERS-CoV and related group 2C coronaviruses. In addition, disruption of accessory ORFs in parallel may offer a rapid response platform to attenuation of future emergent strains based on both SARS- and MERS-CoV accessory ORF mutants.

scholarly journals Results availability and timeliness of registered COVID-19 clinical trials: interim cross-sectional results from the DIRECCT study

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e053096
Author(s):  
Maia Salholz-Hillel ◽  
Peter Grabitz ◽  
Molly Pugh-Jones ◽  
Daniel Strech ◽  
Nicholas J DeVito
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Journal Article ◽  
Cross Sectional Study ◽  
Sensitivity Analyses ◽  
Cross Sectional ◽  
Registration Data ◽  
Clinical Trial Registries ◽  
Treatment And Prevention

ObjectiveTo examine how and when the results of COVID-19 clinical trials are disseminated.DesignCross-sectional study.SettingThe COVID-19 clinical trial landscape.Participants285 registered interventional clinical trials for the treatment and prevention of COVID-19 completed by 30 June 2020.Main outcome measuresOverall reporting and reporting by dissemination route (ie, by journal article, preprint or results on a registry); time to reporting by dissemination route.ResultsFollowing automated and manual searches of the COVID-19 literature, we located 41 trials (14%) with results spread across 47 individual results publications published by 15 August 2020. The most common dissemination route was preprints (n=25) followed by journal articles (n=18), and results on a registry (n=2). Of these, four trials were available as both a preprint and journal publication. The cumulative incidence of any reporting surpassed 20% at 119 days from completion. Sensitivity analyses using alternate dates and definitions of results did not appreciably change the reporting percentage. Expanding minimum follow-up time to 3 months increased the overall reporting percentage to 19%.ConclusionCOVID-19 trials completed during the first 6 months of the pandemic did not consistently yield rapid results in the literature or on clinical trial registries. Our findings suggest that the COVID-19 response may be seeing quicker results disclosure compared with non-emergency conditions. Issues with the reliability and timeliness of trial registration data may impact our estimates. Ensuring registry data are accurate should be a priority for the research community during a pandemic. Data collection is underway for the next phase of the DIssemination of REgistered COVID-19 Clinical Trials study expanding both our trial population and follow-up time.

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