COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04370262

Joseph Conigliaro, MD

Julie DiGregorio, jdigregori@northwell.edu (PI email not reported)

2020-04-30

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. understands and agrees to comply with planned study procedures. male or non-pregnant female adult ≥18 years of age at time of enrollment. subject consents to randomization within 36 hours of hospital admission. has radiographic confirmed covid-19 disease < 72 hours prior to randomization. illness of any duration, and at least one of the following: radiographic infiltrates by imaging (chest x-ray, ct scan, etc.), or clinical assessment (evidence of rales/crackles on exam) and spo2 ≤ 94% on room air, or requiring mechanical ventilation and/or supplemental oxygen. subjects do not require laboratory confirmation of the corona virus sars-cov-2 to determine eligibility women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (acceptable methods will be determined by the site).

mild covid-19 disease (minor clinical symptoms, imaging does not show signs of lung inflammation) recent history of or any in-hospital exposure to investigational medications targeting covid-19, or concurrent participation in a clinical trial targeting covid-19 alt/ast > 5 times the upper limit of normal. moderate renal insufficiency (creatinine clearance 30-50 ml/min) or stage 4 severe chronic kidney disease or requiring dialysis (i.e. creatinine clearance <30 ml/min) history of or evidence of qt prolongation on ecg examination history of psoriasis or porphyria absolute neutrophil count (anc) is < 2000 mm3 pregnancy history of hepatic disease, hepatitis c infection, or alcoholism history of g-6-pd (glucose-6-phosphate dehydrogenase) deficiency concomitant use of the following medications: atazanavir, dasatinib, neratinib, ozanimod, pazopanib, rilpivirine, siponimod, and/or tizanidine. anticipated transfer to another hospital which is not a study site within 72 hours. allergy to any study medication known to be immunocompromised by disease or treatment for existing disease

2

Northwell Health

18

None

United States

Severe disease at enrollment

6: Severe disease at enrollment

233

Mortality

None

Phase 3

[{"arm_notes": "", "treatment_id": 503, "treatment_name": "Famotidine", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]