NCT05077332

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Leidos Life Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Famotidine	80 mg tablet, QID for 14 days
DRUG	Celecoxib	400 mg (initial dose) then 200 mg capsule, BID for 5 days
OTHER	Placebo	tablet, QID for 14 days; capsule, BID for 5 days

Timeline

• Start date: 2021-12-29
• Primary completion: 2025-11-10
• Completion: 2025-11-10
• First posted: 2021-10-14
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study