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Nonsteroidal Anti-inflammatory Drug

Famotidine for Coronavirus Disease

Phase 2
Waitlist Available
Research Sponsored by Leidos Life Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This study is evaluating whether a combination of two drugs might be more effective than either drug alone in treating COVID-19.

Eligible Conditions
  • COVID-19
  • Coronavirus Disease
  • Coronavirus
  • Coronavirus Pandemic

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality).
Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity
Secondary outcome measures
Incidence of Treatment-Emergent Serious Adverse Events (SAE) as assessed by participant withdrawal
Incidence of death

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1 (Study Product)Experimental Treatment2 Interventions
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.
Group II: Group 2 (Reference Therapy)Placebo Group1 Intervention
Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
2019
Completed Phase 4
~1740
Famotidine
2005
Completed Phase 4
~1700

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
865 Previous Clinical Trials
327,690 Total Patients Enrolled
Leidos Life SciencesLead Sponsor
2 Previous Clinical Trials
2,000 Total Patients Enrolled
Brian A Roberts, MS, PMPStudy DirectorLeidos, Inc.
2 Previous Clinical Trials
2,000 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Integrated Therapeutic Solutions USA, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2)
2021. "Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05077969.
~3 spots leftby Apr 2025
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