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

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

Detailed Description
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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.

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

Conditions
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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

Intervention / Treatment
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* Drug: Famotidine
* Drug: Celecoxib
* Other: Placebo


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects randomized 1:1, study drug:placebo
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Study Product)<br>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<br>* 80 mg tablet, QID for 14 days<br>* Other names: Pepcid;Drug: Celecoxib<br>* 400 mg (initial dose) then 200 mg capsule, BID for 5 days<br>* Other names: Celebrex;|
| Placebo Comparator: Group 2 (Reference Therapy)<br>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<br>* tablet, QID for 14 days; capsule, BID for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (LDOS-21-001-01) Time-to-event to achieve WHO level ≤3 | Evaluation of the time-to-event to achieve a WHO level score ≤3 | 30 days | 
| (LDOS-21-001-01) All-Cause Mortality rate | 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 | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, COVID-19, COVID19, SARS-CoV-2