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

Sponsor

Leidos Life Sciences (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05077332

Collaborator

United States Department of Defense (U.S. Fed)

2,000

Enrollment

Location

Arms

29.1

Anticipated Duration (Months)

68.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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	Drug: Famotidine Drug: Celecoxib Other: Placebo	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Subjects randomized 1:1, study drug:placeboSubjects randomized 1:1, study drug:placebo

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Only the participant is blinded in LDOS-21-001-01 (Addendum #1; inpatient study); All are blinded in LDOS-21-001-02 (Addendum #2; outpatient study).

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 29, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

(LDOS-21-001-01) Time-to-event to achieve WHO level ≤3 [30 days]
Evaluation of the time-to-event to achieve a WHO level score ≤3
(LDOS-21-001-01) All-Cause Mortality rate [30 days]
Measured in whole numbers by participants removed from the study with reason of "death" in the electronic data capture system
(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity [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
(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality) [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.