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

Phase 2

Active, not recruiting

• Conditions: 2019-nCoV Disease; SARS-CoV-2 Infection; SARS-CoV-2 Acute Respiratory Disease; 2019-nCoV Infection; Coronavirus Disease 2019; 2019 Novel Coronavirus Disease; COVID-19 Virus Infection; COVID-19; 2019 Novel Coronavirus Infection; COVID-19 Pandemic
• Interventions: Drug: Famotidine; Other: Placebo; Drug: Celecoxib

• Registration Number: NCT05077332
• Lead Sponsor: Leidos Life Sciences

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-10-07
• Study First Submitted QC: 2021-10-12
• Study First Posted: 2021-10-14
• Study Start: 2021-12-29
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Study Product)	Famotidine	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.
Group 2 (Reference Therapy)	Placebo	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.
Group 1 (Study Product)	Celecoxib	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.

Primary Outcome Measures

Name	Time	Method
(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-21-001-01) Time-to-event to achieve WHO level ≤3	30 days	Evaluation of the time-to-event to achieve a WHO level score ≤3
(LDOS-21-001-02) 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.

Trial Locations

Locations (1)

US02-04: Integrated Health Solutions; 🇺🇸 Miami, Florida, United States