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

NCT ID: NCT05077969

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-29
• Study Completion Date: 2022-07-08

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.

Detailed Description

Qualifying patients will have been confirmed positive for COVID-19 and have symptoms of World Health Organization (WHO) Ordinal Scale for Clinical Improvement with scores of ≤3 on the 11-point scale and will be randomly assigned, in a 1:1 ratio, to one of two regimens, with 659 participants per group, as follows:

Group 1 (study product) participants will receive 80 mg famotidine by mouth (PO) 4 times per day (QID) + 400 mg celecoxib as a first dose, followed by 200 mg celecoxib (PO) 2 times per day (BID), for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.

Group 2 (reference therapy) 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.

Safety and efficacy of famotidine and celecoxib will be evaluated.

This is a completely virtual trial and you can participate from your own home. Please call 1-888-370-9330 to speak to someone regarding study participation in your area.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1 (Study Product)

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 Type: EXPERIMENTAL

Famotidine

Intervention Type: DRUG

80 mg tablet, QID for 14 days

Celecoxib

Intervention Type: DRUG

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

Group 2 (Reference Therapy)

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Famotidine

80 mg tablet, QID for 14 days

Intervention Type: DRUG

Celecoxib

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Pepcid; Celebrex

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

1. drugs dependent on gastric pH for absorption, e.g., dasatinib, delavirdine, mesylate, cefditoren, and fosamprenavir;

2. tizanidine (CYP1A2) substrate;

3. drugs that interfere with hemostasis (e.g., warfarin, aspirin, selective serotonin reuptake inhibitors [SSRIs]/serotonin norepinephrine reuptake inhibitors (SNRIs]);

4. angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARB), or beta-blockers;

5. diuretics;

6. 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
• Any contraindication for famotidine or celecoxib treatment:

1. Famotidine or celecoxib hypersensitivity

2. Retinopathy, visual field or visual acuity disturbances

3. History of cardiovascular disease, such as congestive heart failure, QT prolongation, myocardial infarction, bradycardia (<50 bpm), ventricular tachycardia, other arrhythmias

4. Myasthenia gravis

5. Psoriasis or porphyria

6. History of renal failure/dialysis or a glomerular clearance <60 mL/min

7. History of severe hypoglycemia

8. Moderate or severe hepatic impairment, e.g., Child-Pugh Class B or C

9. Known or suspected to be poor CYP2C9 metabolizers based on genotype or previous history or experience with other CYP2C9 substrates, such as warfarin and phenytoin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Leidos Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian A Roberts, MS, PMP

Role: STUDY_DIRECTOR

Leidos, Inc.

Locations

Integrated Therapeutic Solutions USA, Inc.

Newport Beach, California, United States

Integrated Therapeutic Solutions USA, Inc.

Miami, Florida, United States

Integrated Health Solutions USA, Inc.

Atlanta, Georgia, United States

Integrated Therapeutic Solutions USA, Inc

Hazlehurst, Georgia, United States

Integrated Therapeutic Solutions USA, Inc.

Chicago, Illinois, United States

Integrated Therapeutic Solutions USA, Inc

Prospect, Kentucky, United States

Integrated Therapeutic Solutions USA, Inc

Frederick, Maryland, United States

Integrated Therapeutic Solutions USA, Inc

Gaithersburg, Maryland, United States

Integrated Therapeutic Solutions USA, Inc

Rockville, Maryland, United States

Integrated Therapeutic Solutions USA, Inc

Dearborn, Michigan, United States

Integrated Therapeutic Solutions USA, Inc.

Newark, New Jersey, United States

Integrated Therapeutic Solutions USA, Inc.

New York, New York, United States

Integrated Therapeutic Solutions USA, Inc.

Huntingdon, Pennsylvania, United States

Integrated Therapeutic Solutions USA, Inc.

Charleston, South Carolina, United States

Integrated Therapeutic Solutions USA, Inc.

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

LDOS-21-001-02

Identifier Type: -

Identifier Source: org_study_id