Treatment Arm 2 for Respiratory Distress Syndrome, Newborn

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
PRX Research, Mesquite, TX
Respiratory Distress Syndrome, Newborn+5 More
EXOFLO - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Extracellular Vesicle Infusion as Early Goal Directed Therapy for COVID-19 related ARDS (EXTINGuish COVID-19) is a multicenter, double-blinded, placebo-controlled, randomized clinical trial to evaluate the efficacy of ExoFlo in treating moderate to severe ARDS caused by COVID-19.

Eligible Conditions

  • Respiratory Distress Syndrome, Newborn
  • COVID-19 Acute Respiratory Distress Syndrome

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 60 days

60 days
Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles as Early Goal Directed Therapy for COVID-19 Related Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS): A Phase III Clinical Trial.
The primary efficacy endpoint is overall 60-day mortality (due to any cause).

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Treatment Arm 2
1 of 2
Treatment Arm 1
1 of 2
Experimental Treatment
Non-Treatment Group

400 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment Arm 2 · Has Placebo Group · Phase 3

Treatment Arm 2
Drug
Experimental Group · 1 Intervention: EXOFLO · Intervention Types: Drug
Treatment Arm 1
Drug
PlaceboComparator Group · 1 Intervention: EXOFLO · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 days
Closest Location: PRX Research · Mesquite, TX
2021First Recorded Clinical Trial
1 TrialsResearching Respiratory Distress Syndrome, Newborn
1 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have severe or critical COVID-19.
You are positive for SARS-CoV-2.
You have symptoms suggestive of COVID-19 infection.
You provide informed consent prior to the initiation of any study procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.