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Virus Therapy

Exosome Therapy for COVID-19 (ARDOXSO Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by AVEM HealthCare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with moderate to severe ARDS as defined by Berlin Criteria
Patients who require invasive mechanical ventilation (IMV)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

ARDOXSO Trial Summary

This trial is testing if using an antibody to block the inflammation will help people with coronavirus.

Who is the study for?
Adults over 18 needing mechanical breathing support due to severe lung damage from COVID-19, with confirmed infection and specific breathing difficulties. Excluded are those with other active infections, on certain long-term drugs, pregnant or nursing women, and anyone too ill to likely survive a day after joining.Check my eligibility
What is being tested?
The trial tests MSC-exosome therapy for severe respiratory issues from COVID-19. Patients receive exosomes intravenously every other day in different dosages: either the same dose each time or escalating doses to see which is more effective.See study design
What are the potential side effects?
Potential side effects of MSC-exosome treatment could include reactions at the infusion site, immune system responses like fever or fatigue, and possible allergic reactions if there's a history of sensitivity to similar treatments.

ARDOXSO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with moderate to severe ARDS.
Select...
I need a machine to help me breathe.
Select...
I am 18 years old or older.
Select...
My lung scans show widespread shadowing in both lungs.

ARDOXSO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure and report the number of participants with treatment-related-adverse events as assessed by CTCAE v4.0; for patients receiving ARDOXSO™, perinatal MSC-derived exosome therapy.
Tabulate and report the number of IMV days for patients receiving ARDOXSO™ perinatal MSC-derived exosome therapy.
Secondary outcome measures
Analyze and report organ failure, associated with ICU mortality in participants confirmed with SARS-CoV2 infection, receiving ARDOXSO™ as an interventional exosome therapy.
Record and analyze respiratory measures (Berlin Score/PEEP) following treatment regime.

ARDOXSO Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Escalating Dose Third CohortExperimental Treatment1 Intervention
Five patients will receive a treatment dose of 8 X 10^9 exosomes every other day for a period of 5 days, with a minimum of 24 hours between doses recorded.
Group II: Escalating Dose Second CohortExperimental Treatment1 Intervention
Second Cohort: Five patients will receive an escalating dose every other day for a period of 5 days, with a minimum of 24 hours between doses recorded. Dose escalation will begin at 4 x 10^9 exosomes.
Group III: Escalating Dose First CohortExperimental Treatment1 Intervention
First Cohort: Five patients will receive an escalating dose every other day for a period of 5 days, with a minimum of 24 hours between doses recorded. Dose escalation will begin at 2 x 10^9 exosomes
Group IV: Treatment Dose Fourth Cohort Randomized control ratio 1:3Placebo Group1 Intervention
Fourth Cohort: Randomized Cohort Up to 40 patients may be enrolled in this phase of the trial. For those receiving the placebo (~25%), 3 doses will be given over the 5 day period, dispensed from identical vials with physician and patient blinded. The full dose of 8 X 10^9 exosomes will be given to 75% of the patients in 3 doses over the course of 5 days, with one dose occurring every other day.

Find a Location

Who is running the clinical trial?

AVEM HealthCareLead Sponsor

Media Library

Coronavirus Clinical Trial 2023: MSC-exosomes Highlights & Side Effects. Trial Name: NCT04798716 — Phase 1 & 2
MSC-exosomes (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04798716 — Phase 1 & 2

Frequently Asked Questions

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

Are there any available positions for people who want to participate in this research?

"The clinical trial in question was last updated over a year ago, leading us to believe that it is no longer active. However, there are nearly 3000 other trials that patients can participate in."

Answered by AI
Recent research and studies
~23 spots leftby Sep 2024