Reconvalescent Plasma/Camostat Mesylate Early in SARS-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to
evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control
or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe
COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of
convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease
progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of
moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative
number of individuals who progressed to or beyond category 4b on the modified WHO (World
Health Organization) COVID-19 ordinal scale within 28 days after randomization.
Phase:
Phase 2
Details
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborator:
The Federal Ministry of Health, Germany (Bundesministerium für Gesundheit, BMG)