deltatrials
Completed PHASE2 INTERVENTIONAL 3-arm NCT04493242

Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS (EXIT-COVID19)

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): A Phase II Clinical Trial

Sponsor: Direct Biologics, LLC

Conditions ARDS COVID-19
Interventions ExoFlo Intravenous normal saline
Updated 10 times since 2020 Last updated: Feb 9, 2024 Started: Sep 24, 2020 Primary completion: May 1, 2021 Completion: May 22, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on ARDS and COVID-19, this trial is completed. The trial is conducted by Direct Biologics, LLC and has accumulated 10 data snapshots since 2020. Infectious disease trials contribute critical data for public health response and treatment development.

Status Flow

~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshotNot Yet Recruiting~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotNot Yet Recruiting~Sep 2021 – ~Jan 2022 · 4 months · monthly snapshotCompleted~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshotCompleted~Feb 2022 – ~Feb 2023 · 12 months · monthly snapshotCompleted~Feb 2023 – ~May 2023 · 3 months · monthly snapshotCompleted~May 2023 – ~Mar 2024 · 10 months · monthly snapshotCompleted~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

10 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Mar 2024 — Jul 2024 [monthly]

    Completed PHASE2

  4. May 2023 — Mar 2024 [monthly]

    Completed PHASE2

  5. Feb 2023 — May 2023 [monthly]

    Completed PHASE2

▶ Show 5 earlier versions

  1. Feb 2022 — Feb 2023 [monthly]

    Completed PHASE2

  2. Jan 2022 — Feb 2022 [monthly]

    Completed PHASE2

  3. Sep 2021 — Jan 2022 [monthly]

    Completed PHASE2

    Status: Not Yet Recruiting → Completed

  4. Jan 2021 — Sep 2021 [monthly]

    Not Yet Recruiting PHASE2

  5. Aug 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Direct Biologics, LLC
Data source: Direct Biologics, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations