LEAP-CT for Treatment of COVID-19 Patients (Master Protocol)
NCT05077332 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2025-12-16
Summary
This master protocol serves as a common reference for the inpatient and outpatient clinical studies that share common elements.
Conditions
- 2019 Novel Coronavirus Disease
- 2019 Novel Coronavirus Infection
- 2019-nCoV Disease
- 2019-nCoV Infection
- COVID-19 Pandemic
- COVID-19 Virus Disease
- COVID-19 Virus Infection
- Covid19
- Coronavirus Disease 2019
- SARS-CoV-2 Infection
- SARS-CoV-2 Acute Respiratory Disease
- COVID-19
Interventions
- DRUG
-
Famotidine
80 mg tablet, QID for 14 days
- DRUG
-
Celecoxib
400 mg (initial dose) then 200 mg capsule, BID for 5 days
- OTHER
-
Placebo
tablet, QID for 14 days; capsule, BID for 5 days
Sponsors & Collaborators
-
United States Department of Defense
collaborator FED -
Leidos Life Sciences
lead INDUSTRY
Principal Investigators
-
Brian A Roberts, MS, PMP · Leidos, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-29
- Primary Completion
- 2025-11-10
- Completion
- 2025-11-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
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