Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients
Purpose
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.
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants randomized 1:1, study drug:placebo
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- Double-blind
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Placebo Comparator 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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT05077969
- Status
- Terminated
- Sponsor
- Leidos Life Sciences
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.