LEAP-CT for Treatment of COVID-19 Patients (Master Protocol)

NCT05077332 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-12-16

No results posted yet for this study

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

More Related Trials

Entities

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 NCT05077332 on ClinicalTrials.gov