Tolerability and Efficacy of RJX in Patients With COVID-19 — RJX  

COVID-19 Clinical Trial

Official title: 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

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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 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). ;

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• Hypoxemia
• Hypoxia
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• SARS-CoV-2

• NCT number: NCT04708340
• Study type: Interventional
• Source: Reven Pharmaceuticals, Inc.
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: March 25, 2021
• Completion date: February 2023