Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2)

  • STATUS
    Not Recruiting
  • End date
    Nov 16, 2022
  • participants needed
    1465
  • sponsor
    Leidos Life Sciences
Updated on 8 August 2022

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.

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.

Details
Condition 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
Treatment Placebo, Celecoxib, Famotidine
Clinical Study IdentifierNCT05077969
SponsorLeidos Life Sciences
Last Modified on8 August 2022

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