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LEAP-CT in Hospitalized Patients with COVID-19

Title 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
Therapeutic Area Covid-19
Principal Investigator Brian Chow, MD
Min Age 18 Years
Gender Any
Contact Rebecca Badore
617-636-4714
rbadore@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT05085574

Overview

This study is looking at the use of famotidine (known as Pepcid AC, an antiulcer medication) and celecoxib (known as CeleBREX, an arthritis medication) as a treatment to help to reduce the symptoms of COVID-19. Participants will be randomly assigned to one of two groups. One group will be given the medications while the other group will be given a placebo with no medical effect.

Study Details

Inclusion Criteria

1. Male or female above the age of 18 years old
2. Diagnosed with COVID-19 or have had symptoms start in the last 7 days of being in the hospital
3. Access to the internet

Exclusion Criteria

1. Pregnant or breastfeeding
2. History of HIV
3. History of immunosuppression, asthma, or other allergic-type reactions after taking aspirin or other NSAIDs

Study Requirements

The study is conducted for 90 days after first taking the study drugs or placebo which will be taken by mouth. This includes the days hospitalized and then 3 follow-up visits conducted at 30, 60 and 90 days after discharge on-site. Daily blood draws and and one ECG will be done while hospitalized. A PCR test for COVID-19 will be done upon discharge from the hospital and CT Scans on the chest will be done on the 30 and 90 follow-up visits.