Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (Addendum 2)

• Status: Not yet recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leidos Life Sciences
• Collaborator: United States Department of Defense
• Treatments: Celecoxib; Famotidine

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