LEAP-CT for Treatment of COVID-19 Patients (Master Protocol)

Purpose

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

Conditions

  • 2019 Novel Coronavirus Disease
  • 2019 Novel Coronavirus Infection
  • 2019-nCoV Disease
  • 2019-nCoV Infection
  • COVID-19 Pandemic
  • COVID-19 Virus Disease
  • COVID-19 Virus Infection
  • Covid19
  • Coronavirus Disease 2019
  • SARS-CoV-2 Infection
  • SARS-CoV-2 Acute Respiratory Disease
  • COVID-19

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.