Your session is about to expire
← Back to Search
Other
Tolerability and Efficacy of RJX in Patients With COVID-19 (RJX Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Reven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60-days post enrollment
Summary
This trial tests RJX, a treatment for hospitalized COVID-19 patients with mild to moderate breathing issues. RJX is given daily to see if it helps patients recover faster and avoid severe complications.
Eligible Conditions
- Coronavirus
- Low Oxygen Levels
- Acute Respiratory Distress Syndrome
- COVID-19
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60-days post enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60-days post enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy measured by time to resolution of respiratory failure
Safety as measured by DLTs and drug related SAE's
Tolerability and Efficacy measured by progression of disease through an ordinal scale.
Secondary study objectives
Efficacy as measured by day of ICU care.
Efficacy measured by mean change in baseline clinical status on Days 7 and 14.
Efficacy measured by mean change in hospitalization days on Days 7 and 14.
+3 moreOther study objectives
Evaluate Change in Plasma ascorbic acid Concentration
Evaluate Change in Serum C3 Concentration
Evaluate Change in Serum C5 Concentration
+11 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Arm A: RJXActive Control1 Intervention
1. RJX 20 mL (10 mL of Vial A plus 10 mL of Vial B) mixed in normal saline, total volume 120 mL, administered by IV infusion over a period of 40 minutes +/- 10 minutes once daily.
2. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment).
3. Patients in Part 1 are allowed to receive only one 7-day cycle of RJX while patients in Part 2 may be treated daily for up to 14 days.
Group II: Arm B: PlaceboPlacebo Group1 Intervention
1. Placebo (total of 20 mL normal saline) mixed in normal saline IV, total volume 120 mL of normal saline IV, administered by IV infusion over a period of 40 minutes +/- 10 minutes once daily.
2. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment).
3. Patients in Part 1 will not receive placebo.
4. Patients in Part 2 may be treated daily for up to 14 days.
Find a Location
Who is running the clinical trial?
Reven Pharmaceuticals, Inc.Lead Sponsor
2 Previous Clinical Trials
396 Total Patients Enrolled