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

Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) to Evaluate the Safety and Efficacy of Drug Combinations in COVID-19 Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05077332

Enrollment

Registered

2021-10-14

Start date

2021-12-29

Completion date

2025-11-10

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

COVID-19, COVID, COVID19, SARS-CoV-2

Brief summary

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

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.

Interventions

DRUGFamotidine

80 mg tablet, QID for 14 days

DRUGCelecoxib

400 mg (initial dose) then 200 mg capsule, BID for 5 days

OTHERPlacebo

tablet, QID for 14 days; capsule, BID for 5 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, 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).

Intervention model description

Subjects randomized 1:1, study drug:placebo

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
(LDOS-21-001-01) Time-to-event to achieve WHO level ≤3	30 days	Evaluation of the time-to-event to achieve a WHO level score ≤3
(LDOS-21-001-01) All-Cause Mortality rate	30 days	Measured in whole numbers by participants removed from the study with reason of death in the electronic data capture system
(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity	30 days	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
(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality)	30 days	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026