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

This is an interventional treatment trial for 2019 Novel Coronavirus Disease focused on measuring COVID-19, COVID, COVID19, SARS-CoV-2 Read More

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