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

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AVEM HealthCare

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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