Status:
TERMINATED
Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019
Lead Sponsor:
EyePoint Pharmaceuticals, Inc.
Conditions:
COVID-19
Acute Respiratory Distress Syndrome (ARDS)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose escalation and proof-of-concept study to evaluate the safety and efficacy of razuprotafib, administe...
Detailed Description
Part 1 was to be a 2-step dose escalation that included approximately 60 subjects. Part 1, Step 1 was to include 30 subjects, and Part 1, Step 2 was to include 30 subjects. Part 1 was designed to prim...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04511650
Start Date
October 21 2020
End Date
February 26 2021
Last Update
June 8 2023
Active Locations (7)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
University of California- Irvine Medical Center
Orange, California, United States, 92868
3
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
4
Snake River Research
Idaho Falls, Idaho, United States, 83404