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Purpose

This master protocol serves as a common reference for the inpatient and outpatient clinical studies that share common elements.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

- For eligibility criteria specific to the protocol, see:

- Addendum #1 (LDOS-21-001-01) or

- Addendum #2 (LDOS-21-001-02)

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Subjects randomized 1:1, study drug:placebo
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
Only the participant is blinded in LDOS-21-001-01 (Addendum #1; inpatient study); All are blinded in LDOS-21-001-02 (Addendum #2; outpatient study).

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1 (Study Product) 		Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.
  • Drug: Famotidine
    80 mg tablet, QID for 14 days
    Other names:
    • Pepcid
  • Drug: Celecoxib
    400 mg (initial dose) then 200 mg capsule, BID for 5 days
    Other names:
    • Celebrex
Placebo Comparator
Group 2 (Reference Therapy) 		Participants 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.
  • Other: Placebo
    tablet, QID for 14 days; capsule, BID for 5 days

Recruiting Locations

More Details

NCT ID
NCT05077332
Status
Active, not recruiting
Sponsor
Leidos Life Sciences

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.