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Arm A: RJX for 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
Awards & highlights

RJX Trial Summary

This trial is testing if a new drug called RJX is safe and effective for treating patients with COVID-19.

Eligible Conditions
  • COVID-19
  • Low Oxygen Levels
  • Coronavirus
  • Acute Respiratory Distress Syndrome

RJX Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Evaluate Change in Plasma ascorbic acid Concentration
Evaluate Change in Serum C3 Concentration
Evaluate Change in Serum C5 Concentration
+11 more

RJX Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Arm A: RJXActive Control1 Intervention
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. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment). 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
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. Standard of care (current antiviral and/or supportive care treatment currently in place at the institution for COVID-19 treatment). Patients in Part 1 will not receive placebo. 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other similar research projects to Arm A: RJX?

"There are currently one hundred and eight clinical trials underway for Arm A: RJX, with thirty of them being Phase 3 studies. Although a few of these research projects are based in Philadelphia, Pennsylvania, there are three hundred and eighty-four locations worldwide where trials for Arm A: RJX are taking place."

Answered by AI

Are patients currently being signed up for this research project?

"The clinical trial mentioned is not recruiting patients at this time. This is according to the most recent update on clinicaltrials.gov, which was edited on 3/14/2022. It's worth mentioning that there are 1577 other trials currently searching for participants."

Answered by AI

How many individuals are being asked to participate in this research project?

"Unfortunately, this particular clinical trial is no longer looking for new patients. The study was first posted on 3/25/2021 and had its last update on 3/14/202. On the bright side, there are other ongoing studies that might be a better fit; as of now, 1469 trials concerning covid-19 are actively recruiting patients while 108 trials in Arm A: RJX specifically are also open for recruitment."

Answered by AI

What are the aims of this particular clinical trial?

"The aim of this clinical trial is to evaluate the tolerability and efficacy of the medication, as measured by progression of disease through an ordinal scale, over a period of up to 60 days after enrollment. Secondary objectives include assessing the efficacy of the medication, as measured by time to coming off supplemental oxygen on Days 7 and 14, and hospitalization days on Days 7 and 14. Safety and tolerability will also be monitored throughout the study."

Answered by AI

What condition does Arm A: RJX target?

"Arm A: RJX can be used to treat common conditions such as diarrhea, a runny nose, and inflammation of the nasal mucosa."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Memorial Hermann Memorial City Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

To help others.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Tolerability and Efficacy of RJX in Patients With COVID-19
2021. "Tolerability and Efficacy of RJX in Patients With COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04708340.
~59 spots leftby Apr 2025
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