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Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients

NCT05077969 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-07-09

Study results available
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Summary

This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib. Each of these agents separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and each of which appear to have separate and complementary mechanisms of action.

Conditions

  • 2019 Novel Coronavirus Disease
  • 2019 Novel Coronavirus Infection
  • 2019-nCoV Disease
  • 2019-nCoV Infection
  • COVID-19
  • COVID-19 Pandemic
  • COVID-19 Virus Disease
  • COVID-19 Virus Infection
  • Covid19
  • Coronavirus Disease 2019
  • SARS-CoV2 Infection
  • SARS-CoV-2 Acute Respiratory Disease

Interventions

DRUG

Famotidine

80 mg tablet, QID for 14 days

DRUG

Celecoxib

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

DRUG

Placebo

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Leidos Life Sciences

    lead INDUSTRY

Principal Investigators

  • Brian A Roberts, MS, PMP · Leidos, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-29
Primary Completion
2022-06-28
Completion
2022-07-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077969 on ClinicalTrials.gov