Multi-site Adaptive Trials for COVID-19
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Coronavirus, Famotidine
Eligibility Criteria
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).
Exclusion Criteria:
- 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
Sites / Locations
- Southside Hospital
- North Shore University Hospital
- Northern Westchester Hospital
- Lenox Hill Hospital
- Long Island Jewish Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
SOC/Famotidine
SOC/Placebo
Subjects in this study arm will receive a combination of Standard of Care (SOC) treatment and intravenous famotidine. Famotidine Injection, 10mg/mL mixed with Normal Saline is given intravenously at 120mg (30% of 400 mg oral dose). The total daily dose proposed is 360mg/day famotidine IV for a maximum of 14 days, or hospital discharge, whichever comes first. SOC will be administered as per the current clinical protocol for COVID-19.
Subjects in this arm will receive the current Standard of Care treatment for COVID-19; plus placebo infusion three times daily.