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The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19

NCT04798716 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-03-11

No results posted yet for this study

Summary

Novel coronavirus pneumonia (NCP) and acute respiratory distress syndrome (ARDS) are both associated with the prevailing upper respiratory tract infections caused by the RNA-containing SARS-CoV2 virus of the genius Betacoronavirus of the Coronaviridae family. As both the viral infiltration and infection progress, the host immune system response can be one of a rapidly developing fatal cytokine storm. In the ARDS or NCP ensuing progression, the patient often succumbs to the effects of the hyper pro-inflammatory response, hence contributing to the associated increased mortality as a result of the cytokine storm and associated pathogenesis.

Conditions

  • Covid19
  • Novel Coronavirus Pneumonia
  • Acute Respiratory Distress Syndrome

Interventions

DRUG

MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8)

Escalating dose 2 X 10\^9, 4 X 10\^9, 8 X 10\^9/mL

DRUG

MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8)

Escalating dose 8 X 10\^9, 4 X 10\^9, 8 X 10\^9 mL

DRUG

MSC-exosomes delivered intravenously every other day (8:8:8)

Dosed 8 X 10\^9, 8 X 10\^9, 8 X 10\^9 mL

Sponsors & Collaborators

  • AVEM HealthCare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-09-30
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04798716 on ClinicalTrials.gov