Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT05077969
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05077969
Study Brief:
Protocol Section:
NCT05077969