Tolerability and Efficacy of RJX in Patients With COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Respiratory Distress Syndrome
- COVID-19
- Hypoxemia
- Sars Cov 2
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: In Part 1, RJX will be administered daily for 7 days (1 cycle). In Part 2, Placebo or RJX will be administered daily for 7 days for 1 cycle but may receive 2 cycles. Each Cohort is comprised of Part 1, a single site, and Part 2, multiple sites. The 2 Cohorts are: Cohort 1: Hospitalized COVID-19 patients ?18 years without hypoxemia and either not receiving any oxygen therapy OR are receiving supplemental oxygen via mask or nasal prongs (clinical status score 4 or 5 on 8-point ordinal scale). Patients are required to have the following high-risk characteristics Age ?65 years AND type 2 diabetes or hypertension OR Age ?18 years with abnormal blood tests AND CRP >50 mg/L PLUS at least 1 of the following biomarkers abnormal: a. D-dimer, b. Ferritin, c. High sensitivity cardiac troponin, d. LDH Cohort 2: • Hospitalized COVID-19 patients with hypoxemia and without ARDS who are receiving either non-invasive positive pressure ventilation (NIPPV) OR high flow oxygenMasking: Double (Participant, Investigator)Masking Description: Masking the dose administeredPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
For each cohort, there will be an open label Safety Lead-in (Part 1) and a placebo controlled, randomized, double-blind portion (Part 2). In Part 1, RJX will be administered daily for 7 days. In the active treatment arm of Part 2 for both cohorts, RJX will be administered daily for 7 days per cycle ...
For each cohort, there will be an open label Safety Lead-in (Part 1) and a placebo controlled, randomized, double-blind portion (Part 2). In Part 1, RJX will be administered daily for 7 days. In the active treatment arm of Part 2 for both cohorts, RJX will be administered daily for 7 days per cycle and patients may receive up to 2 cycles. As detailed below, patients will be allowed to receive a second 7 day cycle of therapy based on the medical judgment of the Investigator. The total RJX exposure during Part 2 could therefore be up to 14 days. Both cohorts will start and enroll in parallel and independently. A safety follow-up period will begin at Day 14/Discharge, or when treatment is discontinued, and will continue for approximately 60 days post discharge. Part 1 will be conducted at a single site and Part 2 will be conducted at multiple sites. The 2 cohorts in this study are: Cohort 1: Hospitalized COVID-19 patients ?18 years without hypoxemia who are either not receiving any oxygen therapy OR are receiving supplemental oxygen via mask or nasal prongs (namely, clinical status score 4 or 5 on an 8-point ordinal scale). Patients are required to have the following high-risk characteristics Age ?65 years AND type 2 diabetes or hypertension OR Age ?18 years with abnormal blood tests AND CRP >50 mg/L PLUS at least 1 of the following biomarkers: D-dimer >1,000 ng/mL, Ferritin >500 µg/L, High sensitivity cardiac troponin >2 × upper limit of normal (ULN), LDH >245 U/L. Cohort 2: Hospitalized COVID-19 patients with hypoxemia without ARDS who are receiving either non-invasive positive pressure ventilation (NIPPV) OR high flow oxygen (namely, clinical status score 3 on an 8-point ordinal scale).
Tracking Information
- NCT #
- NCT04708340
- Collaborators
- Not Provided
- Investigators
- Not Provided
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