Skip to main content
OpenTrials
Completed

NCT Number: NCT05077332

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

This master protocol serves as a common reference for the inpatient and outpatient clinical studies that share common elements.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

2019 Novel Coronavirus Disease 2019 Novel Coronavirus Infection 2019-nCoV Disease 2019-nCoV Infection COVID-19 COVID-19 Pandemic COVID-19 Virus Disease COVID-19 Virus Infection Coronaviridae Infections Coronavirus Disease 2019 Coronavirus Infections Covid19 Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV-2 Acute Respiratory Disease Sars-CoV-2 Infection Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

US02-04: Integrated Health Solutions

Miami, Florida, 33126, United States

About this study

There are currently two addenda to this master protocol:

Addendum 1, Study LDOS-21-001-01, is a Phase 2, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of the combination of famotidine and celecoxib as a treatment in moderate-to-severe patients hospitalized for COVID-19.

Addendum 2, Study LDOS-21-001-02, is a Phase 2 randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of the combination of famotidine and celecoxib as a post-exposure prophylaxis (PEP) for newly infected COVID-19 patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • For eligibility criteria specific to the protocol, see:
  • Addendum #1 (LDOS-21-001-01) or
  • Addendum #2 (LDOS-21-001-02)

Treatment and study plan

Famotidine

Drug

80 mg tablet, QID for 14 days

Other names: Pepcid

Celecoxib

Drug

400 mg (initial dose) then 200 mg capsule, BID for 5 days

Other names: Celebrex

Placebo

Other

tablet, QID for 14 days; capsule, BID for 5 days

Primary outcomes

  1. (LDOS-21-001-01) Time-to-event to achieve WHO level ≤3

    Time frame: 30 days

    Evaluation of the time-to-event to achieve a WHO level score ≤3

  2. (LDOS-21-001-01) All-Cause Mortality rate

    Time frame: 30 days

    Measured in whole numbers by participants removed from the study with reason of "death" in the electronic data capture system

  3. (LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity

    Time frame: 30 days

    Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" each time, in the electronic data capture system for all study participants

  4. (LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality)

    Time frame: 30 days

    Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" in the electronic data capture system for all study participants.

Sponsors and collaborators

Lead sponsor

Leidos Life Sciences

Industry

Collaborators

  • United States Department of Defense

Registry information

Official study title

Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) to Evaluate the Safety and Efficacy of Drug Combinations in COVID-19 Patients

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 14, 2021
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.