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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
4
80 mg tablet, QID for 14 days
400 mg (initial dose), then 200 mg capsule, BID for 5 days
tablet, QID for 14 days; capsule, BID for 5 days
Integrated Therapeutic Solutions USA, Inc.
Newport Beach, California, United States
Integrated Therapeutic Solutions USA, Inc.
Miami, Florida, United States
Integrated Health Solutions USA, Inc.
Atlanta, Georgia, United States
Integrated Therapeutic Solutions USA, Inc
Hazlehurst, Georgia, United States
Integrated Therapeutic Solutions USA, Inc.
Chicago, Illinois, United States
Integrated Therapeutic Solutions USA, Inc
Prospect, Kentucky, United States
Integrated Therapeutic Solutions USA, Inc
Frederick, Maryland, United States
Integrated Therapeutic Solutions USA, Inc
Gaithersburg, Maryland, United States
Integrated Therapeutic Solutions USA, Inc
Rockville, Maryland, United States
Integrated Therapeutic Solutions USA, Inc
Dearborn, Michigan, United States
...and 5 more locations
Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Increased COVID-19 Symptom Severity
Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" each time, in the electronic data capture system for all study participants.
Time frame: Through Day 30
Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Death (All-cause Mortality).
Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" in the electronic data capture system for all study participants.
Time frame: Through Day 30
Number of Participants With Treatment-Emergent Serious Adverse Events (SAE) as Assessed by Participant Withdrawal
Study discontinuation will be measured in whole units, by number of participants who are removed with the reason of "SAE" and captured by the electronic data capture system.
Time frame: 90 days
Incidence of Death
Deaths will be captured by whole numbers, by number of participants who are removed from the study with reason as "death" in the electronic data capture system.
Time frame: 90 days
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