Arm A: RJX for Coronavirus (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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60-days post enrollment for reporting.

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 more

Other study objectives

Evaluate Change in Plasma ascorbic acid Concentration

Evaluate Change in Serum C3 Concentration

Evaluate Change in Serum C5 Concentration

+11 more

Trial 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.

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