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

Leidos

Status and phase: Active, not recruiting; Phase 2

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

Treatments: Drug: Celecoxib; Drug: Famotidine; Other: Placebo

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT05077332

LDOS-21-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• For eligibility criteria specific to the protocol, see:
• Addendum #1 (LDOS-21-001-01) or
• Addendum #2 (LDOS-21-001-02)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2,000 participants in 2 patient groups, including a placebo group

Group 1 (Study Product)

Experimental group

Description:

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.

Treatment:

Drug: Famotidine

Drug: Celecoxib

Group 2 (Reference Therapy)

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo