Study Stopped
COVID environment, lack of site confidence to enroll subjects, sites not suited to study procedures, decline of potential inpatient subjects at site
Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) in Hospitalized Patients With COVID-19 (Addendum 1)
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
1 other identifier
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
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Started Feb 2023
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2021
CompletedFirst Posted
Study publicly available on registry
October 20, 2021
CompletedStudy Start
First participant enrolled
February 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 7, 2023
CompletedOctober 10, 2023
October 1, 2023
Same day
October 7, 2021
October 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time-to-event to achieve WHO level ≤3
Evaluation of the time-to-event to achieve a WHO level score ≤3
30 days
Death rate
Evaluation of the time-to-event where all-cause mortality occurs
30 days
Secondary Outcomes (4)
Hospital discharge to chronic palliative care
30 days
Hospital discharge with no additional medical care
30 days
Related adverse events (AEs) and serious adverse events (SAEs)
90 days
Study discontinuation due to related AEs or SAEs
90 days
Other Outcomes (9)
Pharmacokinetic (PK) endpoint-Assess area under the curve
14 days
Pharmacokinetic (PK) endpoint-Assess time to maximum plasma concentration
14 days
Pharmacokinetic (PK) endpoint-Assess maximum serum concentration
14 days
- +6 more other outcomes
Study Arms (2)
Group 1 (Study Product)
EXPERIMENTALSubjects 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, subjects will continue their famotidine treatment for an additional 9 days.
Group 2 (Reference Therapy)
PLACEBO COMPARATORSubjects 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.
Interventions
400 mg (initial dose), then 200 mg capsule, BID for 5 days
Eligibility Criteria
You may qualify if:
- Male or female participants must be at least 18 years of age, inclusive, at the time of signing the informed consent form.
- Confirmed COVID-19 or symptom onset within 7 days of hospitalization, as shown by medical history, physical exam, and laboratory tests (PCR), and who have been hospitalized for COVID-19 at WHO Grade 4-5.
- Contraceptive use by men or women should be consistent with Appendix 4 of the Master Protocol (LDOS-21-001).
- Capable of understanding and providing a signed informed consent form.
- Reliable access to the internet.
You may not qualify if:
- Participants are excluded from the study if any of the following criteria apply:
- Pregnant or breastfeeding
- History of HIV
- Ongoing treatment that cannot be temporarily discontinued during the study: anti-inflammatory treatment (nonsteroidal anti-inflammatory drugs \[NSAIDS\]);corticosteroids; antimalarials; antiarrhythmics; tricyclic antidepressants; natalizumab; quinolones; macrolides; and agalsidase alfa and beta
- drugs dependent on gastric pH for absorption, e.g., dasatinib, delavirdine, mesylate, cefditoren, and fosamprenavir;
- tizanidine (CYP1A2) substrate;
- drugs that interfere with hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors \[SSRIs\]/serotonin norepinephrine reuptake inhibitors \[SNRIs\]);
- angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), or beta-blockers;
- diuretics;
- digoxin
- Ongoing famotidine, celecoxib, or other COVID-19 clinical investigational treatment(s) within the past 30 days or current participation in another investigational clinical trial
- History of immunosuppression
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
- Rejection of participation at the discretion of the Principal Investigator or Sponsor
- Any contraindication for famotidine or celecoxib treatment:
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leidos Life Scienceslead
- United States Department of Defensecollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tilly Lawrence, BSN, RN
Leidos, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Single-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2021
First Posted
October 20, 2021
Study Start
February 7, 2023
Primary Completion
February 7, 2023
Study Completion
February 7, 2023
Last Updated
October 10, 2023
Record last verified: 2023-10