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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT05077969

Run by

Leidos Life Sciences

People needed

4

Starts

2021-12-29

Expected to finish

2022-07-08

Last updated by the study team

2024-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Any contraindication for famotidine or celecoxib treatment:
• Famotidine or celecoxib hypersensitivity
• Retinopathy, visual field or visual acuity disturbances
• History of cardiovascular disease, such as congestive heart failure, QT prolongation, myocardial infarction, bradycardia (<50 bpm), ventricular tachycardia, other arrhythmias
• Myasthenia gravis
• Psoriasis or porphyria
• History of renal failure/dialysis or a glomerular clearance <60 mL/min
• History of severe hypoglycemia
• Moderate or severe hepatic impairment, e.g., Child-Pugh Class B or C
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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