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A Two-part, Two-cohort, Double-blind, Randomized, Placebo-controlled, Multicenter Phase 1/2 Study to Evaluate the Safety, Tolerability and Efficacy of REJUVEINIX (RJX) in Patients With COVID-19
This study is designed as a 2-part, 2-cohort, double-blind, randomized, placebo controlled, multicenter Phase 1/2 study to evaluate the safety, tolerability and efficacy of RJX in patients with COVID-19.
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 1. Age ≥65 years AND type 2 diabetes or hypertension OR 2. Age ≥18 years with abnormal blood tests AND CRP \>50 mg/L PLUS at least 1 of the following biomarkers: 1. D-dimer \>1,000 ng/mL, 2. Ferritin \>500 µg/L, 3. High sensitivity cardiac troponin \>2 × upper limit of normal (ULN), 4. 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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States
Memorial Hermann Southeast Hospital
Houston, Texas, United States
Christus Santa Rosa Hospital
New Braunfels, Texas, United States
Start Date
March 25, 2021
Primary Completion Date
October 1, 2022
Completion Date
February 1, 2023
Last Updated
March 15, 2022
237
ESTIMATED participants
Rejuveinix (RJX) Active Comparator
DRUG
Placebo Comparator
DRUG
Lead Sponsor
Reven Pharmaceuticals, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06631287