COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
The overall objective of this study is to efficiently evaluate the clinical efficacy and
safety of different investigational therapeutics among adults who have COVID-19 but are not
yet sick enough to require hospitalization. The overall hypothesis is that through an
adaptive trial design, potential effective therapies (single and combination) may be
identified for this group of patients.
COVID-19 Outpatient Pragmatic Platform Study (COPPS) is a pragmatic platform protocol
designed to evaluate COVID-19 treatments by assessing their ability to reduce viral shedding
(Viral Domain) or improve clinical outcomes (Clinical Domain). To be included into the
platform, every investigational product will collect data for both Domain primary endpoints.
Individual treatments to be evaluated in the platform will be described in separate
sub-protocols.