tetano
Editor, Senior Moderator
J Med Virol
. 2020 Jul 24.
doi: 10.1002/jmv.26338. Online ahead of print.
The mechanistic rationale of drugs, Primary endpoints, Geographical distribution of clinical trials against Severe acute respiratory syndrome-related coronavirus-2: A Systematic Review
Bhanu Prasad Venkatesulu[SUP] 1 [/SUP], Viveksandeep Thoguluva Chandrasekar[SUP] 2 [/SUP], Prashanth Girdhar[SUP] 3 [/SUP], V Pragathee[SUP] 4 [/SUP], Harsh K Patel[SUP] 5 [/SUP], Jacob Manteuffel[SUP] 6 [/SUP]
Affiliations
Abstract
Background: There are numerous ongoing studies assessing treatment options for preventing, treating and managing complications of COVID-19 disease.
Objective: 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.
Methods: ClinicalTrials.gov, World health organization (WHO) International Clinical Trials Registry Platform (ICTRP) and PubMed were assessed till May 11[SUP]th[/SUP] 2020.
Results: 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.
Conclusion: Multiple intervention based clinical studies against SARS-CoV-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. This article is protected by copyright. All rights reserved.
Keywords: COVID-19; Clinical trials; Hydroxychloroquine; Vaccines; systematic review.
. 2020 Jul 24.
doi: 10.1002/jmv.26338. Online ahead of print.
The mechanistic rationale of drugs, Primary endpoints, Geographical distribution of clinical trials against Severe acute respiratory syndrome-related coronavirus-2: A Systematic Review
Bhanu Prasad Venkatesulu[SUP] 1 [/SUP], Viveksandeep Thoguluva Chandrasekar[SUP] 2 [/SUP], Prashanth Girdhar[SUP] 3 [/SUP], V Pragathee[SUP] 4 [/SUP], Harsh K Patel[SUP] 5 [/SUP], Jacob Manteuffel[SUP] 6 [/SUP]
Affiliations
- PMID: 32706390
- DOI: 10.1002/jmv.26338
Abstract
Background: There are numerous ongoing studies assessing treatment options for preventing, treating and managing complications of COVID-19 disease.
Objective: 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.
Methods: ClinicalTrials.gov, World health organization (WHO) International Clinical Trials Registry Platform (ICTRP) and PubMed were assessed till May 11[SUP]th[/SUP] 2020.
Results: 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.
Conclusion: Multiple intervention based clinical studies against SARS-CoV-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. This article is protected by copyright. All rights reserved.
Keywords: COVID-19; Clinical trials; Hydroxychloroquine; Vaccines; systematic review.