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

October 5, 2023 updated by: Leidos Life Sciences

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33126
        • US02-04: Integrated Health Solutions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (Study Product)
Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.
Drug: Famotidine
80 mg tablet, QID for 14 days
Other Names:
  • Pepcid
Drug: Celecoxib
400 mg (initial dose) then 200 mg capsule, BID for 5 days
Other Names:
  • Celebrex
Placebo Comparator: Group 2 (Reference Therapy)
Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, subjects will continue to receive matching famotidine placebo, QID, for an additional 9 days.
Other: Placebo
tablet, QID for 14 days; capsule, BID for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(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
30 days
(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
30 days
(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
30 days
(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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leidos Life Sciences

Collaborators

United States Department of Defense

Investigators

  • Study Director: Brian A Roberts, MS, PMP, Leidos, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2021

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LDOS-21-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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