Lead Investigator: Min-Gul Kim, Jeonbuk National University Hospital
Title of Proposal Research: COVID-19 clinical trial data utilization to develop external control datasets in COVID-19 therapeutics development
Vivli Data Request: 7501
Funding Source: None
Potential Conflicts of Interest: None.
Summary of the Proposed Research:
We are requesting access to the dataset for the purpose of conducting the COVID-19 (coronavirus disease 2019) clinical trial data utilization to develop external control datasets in COVID-19 therapeutics development study. Such investigation is necessary to expedite the development of novel therapeutics against COVID-19. In our study, we tried to create an external control group through propensity score matching from previous COVID-19 clinical studies. Propensity score matching (PSM) is a experimental method in which the researcher uses statistical techniques to construct an artificial control group by matching each treated unit with a non-treated unit of similar characteristics. Using these matches, the researcher can estimate the impact of an intervention. If an external control group is created and evaluated through this study, when developing a COVID-19 treatment using external control group in the future, the time and cost of research for developing a COVID-19 treatment can be reduced and accelerated.
Requested Studies:
Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoC-2 Virus Infection (COVID-19). A Pilot, Randomized, Simple Blind, Placebo-controlled, Parallel-group Study
Data Contributor: Hospital Universitario Austral
Study ID: NCT04463264
Sponsor ID: NTZ-COVID ARG1
Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)
Data Contributor: Montreal Heart Institute
Study ID: NCT04322682
Sponsor ID: MHIPS-2020-001
Randomized Controlled Trial of Losartan for Patients With COVID-19 Requiring Hospitalization
Data Contributor: University of Minnesota
Study ID: NCT04312009
Sponsor ID: SURG-2020-28675
Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization
Data Contributor: University of Minnesota
Study ID: NCT04311177
Sponsor ID: SURG-2020-28683
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients With COVID-19 Infection
Data Contributor: Lilly
Study ID: NCT04421027
Sponsor ID: 17830
A Phase III, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir Plus Tocilizumab Compared With Remdesivir Plus Placebo in Hospitalized Patients With Severe COVID-19 Pneumonia
Data Contributor: Roche
Study ID: NCT04409262
Sponsor ID: WA42511
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MSTT1041A or UTTR1147A in Patients With Severe COVID-19 Pneumonia
Data Contributor: Roche
Study ID: NCT04386616
Sponsor ID: GA42469
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Patients With COVID-19 Pneumonia
Data Contributor: Roche
Study ID: NCT04372186
Sponsor ID: ML42528
An Open-label, Randomized Controlled Trial of Hydroxychloroquine and Azithromycin for COVID-19 Infection on Hospitalized, Noncritical Patients
Data Contributor: HCor Research Institute
Study ID: NCT04322123
Sponsor ID: Brazil COVID Coalition I Trial
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia
Data Contributor: Roche
Study ID: NCT04320615
Sponsor ID: WA42380