This master protocol serves as a common reference for the inpatient and outpatient clinical studies that share common elements.
There are currently two addenda to this master protocol: Addendum 1, Study LDOS-21-001-01, is 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. Addendum 2, Study LDOS-21-001-02, is a 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.
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
US02-04: Integrated Health Solutions
Miami, Florida, United States
(LDOS-21-001-01) Time-to-event to achieve WHO level ≤3
Evaluation of the time-to-event to achieve a WHO level score ≤3
Time frame: 30 days
(LDOS-21-001-01) All-Cause Mortality rate
Measured in whole numbers by participants removed from the study with reason of "death" in the electronic data capture system
Time frame: 30 days
(LDOS-21-001-02) 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: 30 days
(LDOS-21-001-02) 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: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.