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Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1)

NCT05085574 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-10-10

No results posted yet for this study

Summary

This study is designed to test the efficacy and safety of combinations of two well-understood agents - famotidine and celecoxib in patients hospitalized with moderate-to-severe COVID-19 (based on World Health Organization \[WHO\] Ordinal Scale for Clinical Improvement). Both famotidine and celecoxib separately demonstrate clinical activity in mitigating COVID-19 disease symptoms or severity, and 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 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

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

  • Tilly Lawrence, BSN, RN · Leidos, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2023-02-07
Completion
2023-02-07
FDA Drug
Yes

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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 NCT05085574 on ClinicalTrials.gov