Tolerability and Efficacy of RJX in Patients With COVID-19
NCT04708340 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 237
Last updated 2022-03-15
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.
Conditions
- COVID-19
- Acute Respiratory Distress Syndrome
- SARS-CoV-2
- Hypoxemia
Interventions
- DRUG
-
Rejuveinix (RJX) Active Comparator
Active drug comprised of: ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine, riboflavin 5' phosphate, niacinamide, pyridoxine, calcium d-pantothenate, and sodium bicarbonate.
- DRUG
-
Placebo Comparator
0.9% Sodium Chloride in Water for Injection a.k.a. Normal Saline for injection
Sponsors & Collaborators
-
Reven Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-25
- Primary Completion
- 2022-10-31
- Completion
- 2023-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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