NCT05085574

Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1)

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (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 in patients hospitalized with moderate-to-severe COVID-19 (based on World Health Organization \[WHO\] Ordinal Scale for Clinical Improvement). Both famotidine and celecoxib separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and appear to have separate and complementary mechanisms of action.

Detailed description

Participants will be randomly assigned, in a 1:1 ratio, to one of two regimens, with 202 subjects per group as follows: Group 1 (study product) subjects 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, subjects will continue their famotidine treatment for an additional 9 days. Group 2 (reference therapy) subjects 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. Safety, efficacy and pharmacokinetics of famotidine and celecoxib will be evaluated. All participants will receive the standard of care (SOC), which typically consists of remdesivir, decadron (dexamethasone), lovenox, tociluzimab, and convalescent plasma. At the discretion of the investigator, study treatment can be stopped and dexamethasone initiated in study participants who require supplemental oxygen (WHO 5) as outlined in the NIH COVID-19 Treatment Guidelines. Investigators are required to stop study treatment and initiate dexamethasone, as indicated in participants who require high-flow oxygen (WHO 6), non-invasive ventilation (NIV; WHO 6), invasive mechanical ventilation (WHO 7-8) or extracorporeal membrane oxygenation (ECMO; WHO 9), in accordance with the NIH COVID-19 Treatment Guidelines. The NIH COVID-19 Treatment Guidelines recommend against the use of dexamethasone only in hospitalized patients not requiring supplemental oxygen (WHO 4).

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

Timeline

• Start date: 2023-02-07
• Primary completion: 2023-02-07
• Completion: 2023-02-07
• First posted: 2021-10-20
• Last updated: 2023-10-10

Regulatory

• FDA-regulated drug study