Status:
UNKNOWN
The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19
Lead Sponsor:
AVEM HealthCare
Conditions:
Covid19
Novel Coronavirus Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
In December of 2019, in Wuhan, China, a novel coronavirus outbreak began. Globally this disease referred to as COVID-19, is the result of a novel SARS-CoV2 virus which predominantly targets Type II lu...
Eligibility Criteria
Inclusion
- Informed Consent given
- Male and female patients age 18 years or older
- Patients with coronavirus (SARS-CoV-2) infection confirmed prior to enrollment by any test with local regulatory approval
- Patients who require intensive care as determined by the following objective criteria:
- Respiratory rate\>25/minute
- Oxygen saturation \<93% on room air; or the
- Use of high flow oxygen by nasal cannula at a rate ≥ 4L/minute.
- Patients with lung imaging demonstrating bilateral or diffuse pulmonary infiltrates on chest X-ray or CT scan.
- Patients with moderate to severe ARDS as defined by Berlin Criteria
- Patients who require invasive mechanical ventilation (IMV)
Exclusion
- Patients will be excluded from the study if ONE of the following applies:
- History of hypersensitivity to any drugs of similar classes to exosomes
- Suspected active uncontrolled bacterial, fungal, or viral (besides SARS-CoV-2) infection
- Currently receiving ECMO, nitric oxide therapy, or high-frequency oscillatory ventilation
- In the option of the investigator, the patient is unlikely to survive for more than 24 hours post-enrollment
- Patients who are on long-term use of select oral or injectable anti-rejection or immunomodulatory drugs
- Pregnant or nursing (lacking) women
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04798716
Start Date
September 1 2023
End Date
December 1 2024
Last Update
March 11 2022
Active Locations (1)
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1
Mission Community Hospital
Panorama City, California, United States, 91402