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COVID-19 Outpatient Pragmatic Platform Study (COPPS) - Master Protocol

NCT04662086 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2023-06-28

Study results available
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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.

Conditions

  • Covid19

Interventions

DRUG

Acebilustat

100 mg capsule administered orally once daily

DRUG

Camostat

200 mg (2 x 100 mg tablet) administered orally four times daily (800 mg total daily dose).

Sponsors & Collaborators

Principal Investigators

  • Manisha Desai, PhD · Stanford University

  • Upinder Singh, MD · Stanford University

  • Yvonne Maldonado, MD · Stanford University

  • Chaitan Khosla, PhD · Stanford University

  • Haley Hedlin, PhD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-23
Primary Completion
2022-05-03
Completion
2023-02-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04662086 on ClinicalTrials.gov