scholarly journals THE THERAPEUTIC POTENTIAL OF IVERMECTIN FOR COVID-19: A SYSTEMATIC REVIEW OF MECHANISMS AND EVIDENCE

2020 ◽  
Author(s):  
Stefanie Kalfas ◽  
Kumar Visvanathan ◽  
Kim Chan ◽  
John Drago
Keyword(s):  
Clinical Trials ◽  
Therapeutic Potential ◽  
Safety Data ◽  
Clinical Severity ◽  
World Health ◽  
Study Results ◽  
Immunomodulatory Action ◽  
Health Organization ◽  
Clinical Trials Registry

ABSTRACTIntroductionIvermectin is a commonly used antihelminthic agent with over 35 years of established safety data in humans. Recent data demonstrates antiviral activity in vitro against SARS-CoV-2, in addition to a range of viruses. In vitro and animal models also provide evidence of immunomodulatory action. These additional modes of action are supported by in silico modelling, which propose a number of viral and host targets that would mediate these effects.ObjectivesThe aim of this study is to systematically review the published and preprint clinical literature and study results that assessed the potential role of ivermectin as a COVID-19 therapeutic and prophylactic agent.MethodsWe conducted a comprehensive review of PubMed, medRxiv, ClinicalTrials.gov, Global Coronavirus COVID-19 Clinical Trial Tracker, World Health Organization International Clinical Trials Registry Platform, EU Clinical Trials Register, ANZ clinical trials registry, and references from relevant articles.ResultsSearch keywords- “COVID-19 (and synonyms) AND ivermectin”- generated 86 articles on PubMed, 48 on medRvix and 37 on clinicaltrials.gov at the time of writing. Twelve of these were listed as completed clinical trials and of these, 8 were included as investigators had released results. Positive mortality benefit, reduced time to clinical recovery, reduced incidence of disease progression and decreased duration of hospital admission were reported in patients across all stages of clinical severity.LimitationsDue to the time-critical nature of the COVID-19 pandemic our review included preprint data, which must be interpreted with caution while it awaits peer review.

scholarly journals A Systematic Review on the Potency and How Safe Chloroquine is for the Treatment of COVID-19

2020 ◽  
Author(s):  
Aborode Abdullahi Tunde
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Safety Data ◽  
In Vitro Study ◽  
Severe Form ◽  
World Health ◽  
Health Concern ◽  
Long Time ◽  
Health Organization

Coronavirus disease 2019(COVID-19) is a global health emergency of serious health concern. However, there is no current medical treatment, although it is much needed for patient contracting the severe form of the disease. This systematic review was to explain the information regarding chloroquine for the treatment of COVID-19 via the data obtain from PubMed and other three trial Registries which were searched for review and the use of chloroquine in patients with COVID-19. Four articles were included (one narrative letter, one in-vitro study, one commentary and one editorial) and review on other 14 ongoing clinical trials in China. Chloroquine seems to have great potential in reducing the replication of SARS-CoV-2 (virus causing COVID-19) in vitro. There is high chance, pre-clinical evidence of effectiveness and information of safety from long-time clinical use for other indications to describe the clinical research on Chloroquine in patients with COVID-19. However, clinical description should either adhere to the Monitored Emergency Use of Unregistered Interventions (MEURI) framework or be ethically approved as a trial as stated by the World Health Organization. Safety data and data from high-quality clinical trials are urgently needed.

scholarly journals Attribution of non-ClinicalTrials.gov registries among WHO International Clinical Trials Registry Platform-registered trials from 2014 to 2018: A protocol for a meta-epidemiological study

2018 ◽  
Author(s):  
Masahiro Banno ◽  
Yasushi Tsujimoto ◽  
Yuki Kataoka
Keyword(s):  
Clinical Trials ◽  
Epidemiological Study ◽  
Medical Information ◽  
University Hospital ◽  
World Health ◽  
Study Phase ◽  
Target Sample Size ◽  
Registration Number ◽  
Health Organization ◽  
Clinical Trials Registry

Background. The attribution of non-ClinicalTrials.gov registries among registered trials of the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) had increased until 2013. However, the attribution after 2013 is unknown. Moreover, no study has investigated the usage of non-ClinicalTrials.gov registries after 2015 or compared the characteristics of trials under non-ClinicalTrials.gov and ClinicalTrials.gov registries. Methods. This will be a meta-epidemiological study. It will include all trials registered on the ICTRP from January 1, 2014, to December 31, 2018. First, we will describe the total attribution of non-ClinicalTrials.gov registries among the ICTRP-registered trials for each year and each registry worldwide. Second, we will compare the recruitment status, target sample size, study type, study design, countries, prospective registration, funding, and study phase of the trials on ClinicalTrials.gov and other registries from 2014 to 2018. Third, we will report on the distribution of primary registries of trials from the top five countries in order of the quantity of registered trials on the ICTRP. Ethics & Dissemination. Ethics approval is not required for this study. This protocol has been registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). The findings will be published in a peer-reviewed journal and may be presented at conferences. Trial Registration Number. UMIN000034401

scholarly journals Therapeutic Effectiveness and Safety of Repurposing Drugs for the Treatment of COVID-19: Position Standing in 2021

2021 ◽  
Vol 12 ◽  
Author(s):  
Safaet Alam ◽  
Taslima Binte Kamal ◽  
Md. Moklesur Rahman Sarker ◽  
Jin-Rong Zhou ◽  
S. M. Abdur Rahman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Case Series ◽  
Basic Knowledge ◽  
World Health ◽  
Current Status ◽  
Drug Candidates ◽  
Health Organization ◽  
Meta Analyses

COVID-19, transmitted by SARS-CoV-2, is one of the most serious pandemic situations in the history of mankind, and has already infected a huge population across the globe. This horrendously contagious viral outbreak was first identified in China and within a very short time it affected the world's health, transport, economic, and academic sectors. Despite the recent approval of a few anti-COVID-19 vaccines, their unavailability and insufficiency along with the lack of other potential therapeutic options are continuing to worsen the situation, with valuable lives continuing to be lost. In this situation, researchers across the globe are focusing on repurposing prospective drugs and prophylaxis such as favipiravir, remdesivir, chloroquine, hydroxychloroquine, ivermectin, lopinavir-ritonavir, azithromycin, doxycycline, ACEIs/ARBs, rivaroxaban, and protease inhibitors, which were preliminarily based on in vitro and in vivo pharmacological and toxicological study reports followed by clinical applications. Based on available preliminary data derived from limited clinical trials, the US National Institute of Health (NIH) and USFDA also recommended a few drugs to be repurposed i.e., hydroxychloroquine, remdesivir, and favipiravir. However, World Health Organization later recommended against the use of chloroquine, hydroxychloroquine, remdesivir, and lopinavir/ritonavir in the treatment of COVID-19 infections. Combining basic knowledge of viral pathogenesis and pharmacodynamics of drug molecules as well as in silico approaches, many drug candidates have been investigated in clinical trials, some of which have been proven to be partially effective against COVID-19, and many of the other drugs are currently under extensive screening. The repurposing of prospective drug candidates from different stages of evaluation can be a handy wellspring in COVID-19 management and treatment along with approved anti-COVID-19 vaccines. This review article combined the information from completed clinical trials, case series, cohort studies, meta-analyses, and retrospective studies to focus on the current status of repurposing drugs in 2021.

scholarly journals Should chloroquine and hydroxychloroquine be used to treat COVID-19? A rapid review

BJGP Open ◽  
2020 ◽  
Vol 4 (2) ◽  
pp. bjgpopen20X101069 ◽  
Author(s):  
Kome Gbinigie ◽  
Kerstin Frie
Keyword(s):  
Clinical Trials ◽  
Relevant Literature ◽  
Safety Data ◽  
World Health ◽  
Rapid Review ◽  
Current Evidence ◽  
Long Term Follow Up

BackgroundOn the 11 March 2020, the World Health Organization (WHO) declared that COVID-19 was a pandemic. To date, there are no medical treatments for COVID-19 with proven effectiveness. Novel treatments and/or vaccines will take time to be developed and distributed to patients. In light of this, there has been growing interest in the use of existing medications, such as chloroquine (CQ) and hydroxychloroquine (HCQ), as potential treatments of this disease.AimTo establish the current evidence for the effectiveness of CQ and HCQ in treating COVID-19.Design & settingA rapid review of the literature was conducted.MethodElectronic searches in PubMed and Google Scholar were conducted on 21 March 2020. A further search was conducted in Google for relevant literature on 28 March 2020.ResultsThere is limited evidence of in vitro activity of CQ/HCQ against SARS-CoV-2. A number of in vivo clinical trials are underway. The empirical data available from two of these trials reveal conflicting results. Both trials are characterised by small numbers of participants (n = 30 and n = 36) and suffer methodological limitations. No medium or long-term follow-up data is available.ConclusionAt present, there is insufficient evidence to determine whether CQ/HCQ are safe and effective treatments for COVID-19. High quality, adequately powered randomised clinical trials in primary and secondary care settings are urgently required to guide policymakers and clinicians. These studies should report medium- and long-term follow-up results, and safety data.

scholarly journals Exclusion of Pregnant Women from Clinical Trials during the Coronavirus Disease 2019 Pandemic: A Review of International Registries

2020 ◽  
Vol 37 (08) ◽  
pp. 792-799 ◽  
Author(s):  
Devin D. Smith ◽  
Jessica L. Pippen ◽  
Adebayo A. Adesomo ◽  
Kara M. Rood ◽  
Mark B. Landon ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pregnant Women ◽  
World Health ◽  
Eligibility Criteria ◽  
Current State ◽  
Key Points ◽  
State Of Research ◽  
Novel Coronavirus ◽  
Health Organization ◽  
Clinical Trials Registry

Objective Pregnant women have been historically excluded from clinical trials for nonobstetric conditions, even during prior epidemics. The objective of this review is to describe the current state of research for pregnant women during the coronavirus disease 2019 (COVID-19) pandemic. Study Design We conducted a search of international trial registries for trials relating to the novel coronavirus. The eligibility criteria for each trial were reviewed for inclusion/exclusion of pregnant women. Relevant data were extracted and descriptive statistics were calculated for individual and combined data. The total number of trials from each registry were compared, as well as the proportions of pregnancy-related trials within each. Results Among 621,370 trials in the World Health Organization International Clinical Trials Registry, 927 (0.15%) were COVID-19 related. Of those, the majority (52%) explicitly excluded pregnancy or failed to address pregnancy at all (46%) and only 16 (1.7%) were pregnancy specific. When categorized by region, 688 (74.2%) of COVID-19 trials were in Asia, followed by 128 (13.8%) in Europe, and 66 (7.2%) in North America. Of the COVID-19 trials which included pregnant women, only three were randomized-controlled drug trials. Conclusion Approximately 1.7% of current COVID-19 research is pregnancy related and the majority of trials either explicitly exclude or fail to address pregnancy. Only three interventional trials worldwide involved pregnant women. The knowledge gap concerning the safety and efficacy of interventions for COVID-19 created by the exclusion of pregnant women may ultimately harm them. While “ethical” concerns about fetal exposure are often cited, it is in fact unethical to habitually exclude pregnant women from research. Key Points

scholarly journals Trialstreamer: A living, automatically updated database of clinical trial reports

2020 ◽  
Vol 27 (12) ◽  
pp. 1903-1912 ◽  
Author(s):  
Iain J Marshall ◽  
Benjamin Nye ◽  
Joël Kuiper ◽  
Anna Noel-Storr ◽  
Rachel Marshall ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Automated System ◽  
World Health ◽  
Free Text ◽  
Medical Subject Headings ◽  
Gold Standard Method ◽  
Structured Information ◽  
Health Organization ◽  
Clinical Queries ◽  
Clinical Trials Registry

Abstract Objective Randomized controlled trials (RCTs) are the gold standard method for evaluating whether a treatment works in health care but can be difficult to find and make use of. We describe the development and evaluation of a system to automatically find and categorize all new RCT reports. Materials and Methods Trialstreamer continuously monitors PubMed and the World Health Organization International Clinical Trials Registry Platform, looking for new RCTs in humans using a validated classifier. We combine machine learning and rule-based methods to extract information from the RCT abstracts, including free-text descriptions of trial PICO (populations, interventions/comparators, and outcomes) elements and map these snippets to normalized MeSH (Medical Subject Headings) vocabulary terms. We additionally identify sample sizes, predict the risk of bias, and extract text conveying key findings. We store all extracted data in a database, which we make freely available for download, and via a search portal, which allows users to enter structured clinical queries. Results are ranked automatically to prioritize larger and higher-quality studies. Results As of early June 2020, we have indexed 673 191 publications of RCTs, of which 22 363 were published in the first 5 months of 2020 (142 per day). We additionally include 304 111 trial registrations from the International Clinical Trials Registry Platform. The median trial sample size was 66. Conclusions We present an automated system for finding and categorizing RCTs. This yields a novel resource: a database of structured information automatically extracted for all published RCTs in humans. We make daily updates of this database available on our website (https://trialstreamer.robotreviewer.net).

scholarly journals Analysis of the Registration Information on Interventions of Acupuncture and Moxibustion Trials in the International Clinical Trials Registry Platform

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Yali Liu ◽  
Wenjie Chen ◽  
Yingxin Tan ◽  
Xingyue Yang ◽  
Jia Liu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sham Acupuncture ◽  
World Health ◽  
Control Group ◽  
Duration Of Treatment ◽  
Acupuncture And Moxibustion ◽  
Health Organization ◽  
Number Of Treatment ◽  
Clinical Trials Registry

Purpose. To analyze and compare the clinical registration information about acupuncture and moxibustion for intervention characteristics. Methods. Clinical trials from the International Clinical Trials Registry Platform of the World Health Organization in acupuncture and moxibustion were comprehensively collected from 2013 to 2015; data were independently screened and extracted by two retrievers, and relevant data involving either basic descriptions or intervention characteristics were analyzed. Results. 425 acupuncture and moxibustion registered clinical trials were included; 88.00% (374/425) were designed as controlled studies, among which 38.59% (164/425) had sham acupuncture as the control group. The most common diseases were pain-related at approximately 19.29% (82/425) of trials. Reports on the intervention information in these acupuncture and moxibustion clinical studies were not sufficiently presented; these reports included the reporting of names of points (39.8%), the method of needle stimulation (32.5%), needle type (29.6%), needle retention time (34.1%), the number of treatment sessions (22.4%), and the frequency and duration of treatment sessions (38.1%). Conclusion. The registration information for the clinical trials of acupuncture and moxibustion was quite low according to this investigational study. Steps should be taken to improve the quality of acupuncture and moxibustion registration information.

scholarly journals Research methodology and characteristics of journal articles with original data, preprint articles and registered clinical trial protocols about COVID-19

2020 ◽  
Author(s):  
Mahir Fidahic ◽  
Danijela Nujic ◽  
Renata Runjic ◽  
Marta Civljak ◽  
Filipa Markotic ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Case Reports ◽  
Original Data ◽  
World Health ◽  
Journal Articles ◽  
Scholarly Journals ◽  
Trial Protocols ◽  
Reported Study ◽  
Health Organization ◽  
Clinical Trials Registry

Abstract Background The research community reacted rapidly to the emergence of COVID-19. We aimed to assess characteristics of journal articles, preprint articles, and registered trial protocols about COVID-19 and its causal agent SARS-CoV-2.Methods We analyzed characteristics of journal articles with original data indexed by March 19, 2020, in World Health Organization (WHO) COVID-19 collection, articles published on preprint servers medRxiv and bioRxiv by April 3, 2010. Additionally, we assessed characteristics of clinical trials indexed in the WHO International Clinical Trials Registry Platform (WHO ICTRP) by April 7, 2020.Results Among the first 2118 articles on COVID-19 published in scholarly journals, 533 (25%) contained original data. The majority was published by authors from China (75%) and funded by Chinese sponsors (75%); a quarter was published in the Chinese language. Among 312 articles that self-reported study design, the most frequent were retrospective studies (N = 88; 28%) and case reports (N = 86; 28%), analyzing patients’ characteristics (38%). Median Journal Impact Factor of journals where articles were published was 5.099.

scholarly journals A systemic review of clinical trials of COVID-19, registered in WHO-ICTRP

2020 ◽  
Vol 7 (3) ◽  
pp. 212
Author(s):  
Suyog Vyas ◽  
Kartiki S. Vyas
Keyword(s):  
Clinical Trials ◽  
Primary Outcome ◽  
World Health ◽  
Systemic Review ◽  
Plasma Therapy ◽  
Global Response ◽  
Treatment And Prevention ◽  
Health Organization ◽  
Study Type ◽  
Clinical Trials Registry

<p class="abstract">In September 2004, International Commission of Medical Journal Editors implemented a dramatic and important policy for the condition of publication of clinical trials. The condition was that clinical trials must be registered in a public trial registry. World Health Organization-International Clinical Trials Registry Platform (WHO-ICTRP) is the globally centralised network composed of primary registries and partner registries along with data providers. COVID-19 is a pandemic and a significant social and economical health burden. In this event numbers of trials have been undertaken by the medical professionals and research workers in every part of the world. Here we have analysed registered clinical trials for the detection, treatment and prevention of COVID-19 to provide a summary of global response w.s.r.to WHO-ITCRP. The objective of this study was to collect the data of registered clinical trials for the therapeutic and preventive measures for COVID-19 which are registered in WHO-ICTRP and analyse global response of COVID-19. WHO-ITCRP database has 20 fields of mapping. Out of these, we have analysed 6 fields of this registry, for this study purpose: public title, scientific title, study type, countries, intervention and primary outcome. Clinical trials are focused on chloroquine, hydroxychloroquine, lopinavir ritonavir combination, Remdesivir, Favipiravir, Tocilizumab and Interferon. Also, it is seen that convalescent plasma therapy is a promising intervention. Observational trials are directed mainly on the clinical features and distinguish COVID-19 from other influenza like illnesses.</p>

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