The mechanistic rationale of drugs, primary endpoints, geographical distribution of clinical trials against severe acute respiratory syndrome‐related coronavirus‐2: A systematic review
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Abstract
There are numerous ongoing studies assessing treatment options for preventing, treating, and managing complications of coronavirus disease‐2019 disease. The objective of this study was to do a systematic review and critical appraisal of the ongoing clinical trials with an aim to provide insight into the various interventions tested, clinical rationale, geographical distribution of the trials as well as the endpoints assessed in the studies. ClinicalTrials.gov , World Health Organization International Clinical Trials Registry Platform, and PubMed were assessed till 11 May 2020. The search resulted in 3242 ongoing studies of which 829 studies were included. There are 134 different drug‐based interventions being assessed in 463 clinical trials as treatment options China accounts for 35% of all ongoing clinical studies followed by USA 23% and other countries together account for 42%. Amongst the 463 studies assessing drug‐based treatment options, studies that are funded by federal and academic institutions are 79.6%, pharmaceutical company‐funded studies are 15.11%, and no funding information is available in 5.10%. The definitive outcomes like mortality are being assessed as primary outcome in 22.8% of the studies only and need for ventilator in 6.2% of the studies. Amongst the pharmaceutical company‐funded drug‐based studies, only 20% of the studies had mortality as the primary outcome. Only 5.5% of the ongoing clinical trials are specifically designed to assess the most vulnerable population like elderly, patients with comorbidities and cancer. Multiple intervention‐based clinical studies against severe acute respiratory syndrome‐related coronavirus‐2 are being performed throughout the world with a high concentration of clinical trials in the developed world with concern that of elderly and patients with comorbidities are being underrepresented and definite endpoints like mortality are being assessed in only one‐fifth of the studies.
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SciScore for 10.1101/2020.05.24.20112169: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources (Supplementary data) Search strategy: ClinicalTrials.gov, World health organization (WHO) International Clinical Trials Registry Platform (ICTRP) and Cochrane COVID registries were assessed up to May 11th with the search terms coronavirus, SARS-CoV-2 by two independent investigators (BV, VT). Cochrane COVIDsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog…
SciScore for 10.1101/2020.05.24.20112169: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources (Supplementary data) Search strategy: ClinicalTrials.gov, World health organization (WHO) International Clinical Trials Registry Platform (ICTRP) and Cochrane COVID registries were assessed up to May 11th with the search terms coronavirus, SARS-CoV-2 by two independent investigators (BV, VT). Cochrane COVIDsuggested: NoneResults from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Limitations: Newer clinicals are being rapidly initiated and enrolled into the clinical trial registries which makes it difficult for the review to be uptodate. Information regarding the status of clinical trials if they are active or have been terminated or completed is not clearly available from the databases. Though the review accounted for the most of the clinical trial registries, despite our best attempt, it may not be exhaustive enough to account for retrospective registration of all studies. Implications for practice: The majority of ongoing clinical trials seek to enroll patients that may not be representative of the actual population who are at risk of death and morbidity from COVID-19. There needs to be an emphasis on the rationality of the primary endpoints with need for all-cause mortality as the primary endpoint and other patient-related outcomes like need for mechanical ventilation and decreasing length of ICU stay as main secondary outcomes. There needs to be a higher rate of inclusion of patients with co-morbidities in clinical trials to reflect real world scenario for outcomes. Majority of ingoing studies are in the developed world and middle- and low-income countries are at a risk of grossly being underrepresented in the clinical trials.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04292899 Completed Study to Evaluate the Safety and Antiviral Activity of Remde… NCT04322682 Completed Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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