COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05077969

Brian A Roberts

Not reported

2021-10-14

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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.

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

2

Leidos Life Sciences

18

100

United States

Mild disease at enrollment

1: Mild disease at enrollment

9

Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality).;Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity

None

Phase 2

[{"arm_notes": "", "treatment_id": 1991, "treatment_name": "Celecoxib+famotidine", "treatment_type": "Non-steroidal anti-inflammatory+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]