Status:
COMPLETED
Multi-site Adaptive Trials for COVID-19
Lead Sponsor:
Northwell Health
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The overall objective of the study is to evaluate the clinical efficacy of COVID-19 treatments consisting of standard of care (SOC), vs SOC with high dose famotidine in patients hospitalized and meeti...
Detailed Description
In December 2019, the Wuhan Municipal Health Committee identified an outbreak of viral pneumonia cases of unknown cause. Coronavirus RNA was quickly identified in these patients. This novel coronaviru...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2020
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT04370262
Start Date
April 7 2020
End Date
September 7 2020
Last Update
December 11 2020
Active Locations (5)
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1
Southside Hospital
Bay Shore, New York, United States, 11706
2
North Shore University Hospital
Manhasset, New York, United States, 11030
3
Northern Westchester Hospital
Mount Kisco, New York, United States, 10549
4
Lenox Hill Hospital
New York, New York, United States, 10075