COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04511650

Ashley Best, PhD

A.Best1@medpace.com

2020-08-13

Terminated

RCT

Randomized

Sequential assignment

Blind label

multi-center

Treatment

inclusion criteria: ability to understand and provide informed consent; males and non-pregnant females 18 years of age or older at the time of screening; laboratory-confirmed active sars-cov-2 infection within 72 hours prior to randomization, or (if testing results cannot be obtained) by evidence of progressive disease suggestive of ongoing sars-cov-2 infection; females of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception through day 28; and have a negative urine pregnancy test during screening; currently hospitalized, receiving standard of care therapy for covid-19, and meets the criteria for moderate or severe covid-19, as follows: moderate = symptoms of moderate illness with covid-19, which could include any symptom of mild illness or shortness of breath with exertion and with respiratory rate at 20 or greater breaths/min, peripheral capillary oxygen saturation (spo2) >93% on room air at sea level, or heart rate at 90 or greater beats/min; severe = symptoms suggestive of severe systemic illness with covid-19, which could include any symptom of moderate illness, shortness of breath at rest, or respiratory distress, and respiratory rate at 30 or greater breaths/min, heart rate at 125 or greater beats/min, or spo2 >93% on room air at sea level or (partial pressure of oxygen:fraction of inspired oxygen (pao2:fio2) <300.

inability to initiate study drug within 12 hours after randomization; female of childbearing potential who is unable or unwilling to forego breastfeeding through day 28; systolic blood pressure <100 mmhg; in shock or requiring pressor support; respiratory failure, defined as subjects who are on mechanical ventilation; are receiving oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 l/min with fraction of delivered oxygen of 0.5 or greater), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ecmo); or have a clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation); alanine aminotransferase (alt) or aspartate aminotransferase (ast) >3 × the upper limit of normal (uln); total bilirubin >2 × uln; estimated glomerular filtration rate <30 ml/min or receiving hemodialysis or hemofiltration; moribund subject not expected to survive 24 hours in the opinion of the treating clinical team; any concurrent serious medical condition (eg, active malignancies on chemotherapy, post organ transplant, end stage congestive heart failure) or not likely to respond to treatment; decision to withhold life-sustaining treatment; note: in the event of cardiac arrest, the decision to withhold cardiopulmonary resuscitation only does not fulfill this exclusion criterion. use of cytochrome p450 (cyp) 2 subfamily c, polypeptide 8 (2c8) substrates (eg, repaglinide, paclitaxel, or cerivastatin) or cyp3a4 substrates (eg, amlodipine, budesonide, dasabuvir, enzalutamide, imatinib, lopinavir, loperamide, saquinavir, sildenafil, midazolam, or montelukast); use of cyp2c8 inhibitors (eg, gemfibrozil, fluvoxamine, or ketoconazole); participation in another investigational study during the present study through the last visit (day 28); or previous randomization in this study.

3

EyePoint Pharmaceuticals, Inc.

18

100

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

31

Number and Percent of Subjects Who Were Alive and Free of Respiratory Failure Prior to Day 7 and Day 28

None

Phase 2

[{"arm_notes": "10 mg", "treatment_id": 1068, "treatment_name": "Razuprotafib", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "20 mg", "treatment_id": 1068, "treatment_name": "Razuprotafib", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]