Study Stopped
Low recruitment
Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients
A Virtual 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
1 other identifier
interventional
4
1 country
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2021
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2021
CompletedFirst Posted
Study publicly available on registry
October 14, 2021
CompletedStudy Start
First participant enrolled
December 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2022
CompletedResults Posted
Study results publicly available
July 9, 2024
CompletedJuly 9, 2024
July 1, 2024
6 months
October 7, 2021
May 22, 2024
July 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Increased COVID-19 Symptom Severity
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.
Through Day 30
Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Death (All-cause Mortality).
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.
Through Day 30
Secondary Outcomes (2)
Number of Participants With Treatment-Emergent Serious Adverse Events (SAE) as Assessed by Participant Withdrawal
90 days
Incidence of Death
90 days
Study Arms (2)
Group 1 (Study Product)
EXPERIMENTALParticipants 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 2 (Reference Therapy)
PLACEBO COMPARATORParticipants 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.
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 SARS-CoV-2 polymerase chain reaction (PCR) positive patient within 5 days of enrollment, as shown by medical history and reported PCR test result.
- Reports having one or more symptoms consistent with SARS-CoV-2, as defined in Master Protocol Appendix 3 Table 4.
- COVID-19 diagnosis must be WHO grade ≤3.
- Contraceptive use by men or women should be consistent with Appendix 4 of the Master protocol (LDOS-21-001).
- Reliable access to the Internet via a browser installed on personal device or computer.
- Capable of understanding and providing signed informed consent.
You may not qualify if:
- Pregnancy or breastfeeding
- Ongoing antiviral or antiretroviral treatment
- Known history of HIV
- Ongoing anti-inflammatory treatment that cannot be temporarily discontinued during the study. This includes nonsteroidal anti-inflammatory drugs (NSAIDs), and corticosteroids - including Dexamethasone (dexamethasone administration restricted to recommended standard of care use per NIH COVID-19 Guidelines)
- 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 treatment that cannot be temporarily discontinued during the study, with: antimalarials, antiarrhythmics, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta
- Ongoing famotidine or celecoxib or other COVID-19 clinical investigational treatment(s) within the past 30 days, or current participation in another investigational clinical trial
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs
- History of immunosuppression
- Rejection of participation by Principal Investigator or Sponsor
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leidos Life Scienceslead
- United States Department of Defensecollaborator
Study Sites (15)
Integrated Therapeutic Solutions USA, Inc.
Newport Beach, California, 92603, United States
Integrated Therapeutic Solutions USA, Inc.
Miami, Florida, 33126, United States
Integrated Health Solutions USA, Inc.
Atlanta, Georgia, 30363, United States
Integrated Therapeutic Solutions USA, Inc
Hazlehurst, Georgia, 31539, United States
Integrated Therapeutic Solutions USA, Inc.
Chicago, Illinois, 60611, United States
Integrated Therapeutic Solutions USA, Inc
Prospect, Kentucky, 40059, United States
Integrated Therapeutic Solutions USA, Inc
Frederick, Maryland, 21702, United States
Integrated Therapeutic Solutions USA, Inc
Gaithersburg, Maryland, 20878, United States
Integrated Therapeutic Solutions USA, Inc
Rockville, Maryland, 20850, United States
Integrated Therapeutic Solutions USA, Inc
Dearborn, Michigan, 48120, United States
Integrated Therapeutic Solutions USA, Inc.
Newark, New Jersey, 07102, United States
Integrated Therapeutic Solutions USA, Inc.
New York, New York, 10005, United States
Integrated Therapeutic Solutions USA, Inc.
Huntingdon, Pennsylvania, 16652, United States
Integrated Therapeutic Solutions USA, Inc.
Charleston, South Carolina, 29414, United States
Integrated Therapeutic Solutions USA, Inc.
Dallas, Texas, 75219, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was not able to enroll the requisite number of patients to evaluate the prespecified endpoints. As a result the study was halted prematurely.
Results Point of Contact
- Title
- Tilly Lawrence
- Organization
- Leidos, Inc.
Study Officials
- STUDY DIRECTOR
Brian A Roberts, MS, PMP
Leidos, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2021
First Posted
October 14, 2021
Study Start
December 29, 2021
Primary Completion
June 28, 2022
Study Completion
July 8, 2022
Last Updated
July 9, 2024
Results First Posted
July 9, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share
It is not yet known if there will be a plan to make individual participant data (IPD) available.