NCT05077969

Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients

A Virtual 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

• Status: Terminated
• 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 study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib. Each of these agents separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and each of which appear to have separate and complementary mechanisms of action.

Detailed description

Qualifying patients will have been confirmed positive for COVID-19 and have symptoms of World Health Organization (WHO) Ordinal Scale for Clinical Improvement with scores of ≤3 on the 11-point scale and will be randomly assigned, in a 1:1 ratio, to one of two regimens, with 659 participants per group, as follows: Group 1 (study product) participants will receive 80 mg famotidine by mouth (PO) 4 times per day (QID) + 400 mg celecoxib as a first dose, followed by 200 mg celecoxib (PO) 2 times per day (BID), for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days. Group 2 (reference therapy) participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days. Safety and efficacy of famotidine and celecoxib will be evaluated. This is a completely virtual trial and you can participate from your own home. Please call 1-888-370-9330 to speak to someone regarding study participation in your area.

Conditions

• 2019 Novel Coronavirus Disease
• 2019 Novel Coronavirus Infection
• 2019-nCoV Disease
• 2019-nCoV Infection
• COVID-19
• COVID-19 Pandemic
• COVID-19 Virus Disease
• COVID-19 Virus Infection
• Covid19
• Coronavirus Disease 2019
• SARS-CoV2 Infection
• SARS-CoV-2 Acute Respiratory Disease

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
DRUG	Placebo	tablet, QID for 14 days; capsule, BID for 5 days

Timeline

• Start date: 2021-12-29
• Primary completion: 2022-06-28
• Completion: 2022-07-08
• First posted: 2021-10-14
• Last updated: 2024-07-09
• Results posted: 2024-07-09

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study