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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)

Must not have

Suspected active uncontrolled bacterial, fungal, or viral (besides SARS-CoV-2) infection

Currently receiving ECMO, nitric oxide therapy, or high-frequency oscillatory ventilation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

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.

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.

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.

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.

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I need a machine to help me breathe.

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My lung scans show widespread shadowing in both lungs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any suspected active uncontrolled infections.

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I am currently on ECMO, nitric oxide therapy, or high-frequency ventilation.

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I am on long-term medication to suppress my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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.

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.

0 / 6Eligibility criteria met