Covid19 Clinical Trial
— ARDOXSOOfficial title:
Mesenchymal Stem Cell Exosomes for the Treatment of COVID-19 Positive Patients With Acute Respiratory Distress Syndrome and/or Novel Coronavirus Pneumonia
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.
Status | Not yet recruiting |
Enrollment | 55 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mission Community Hospital | Panorama City | California |
Lead Sponsor | Collaborator |
---|---|
AVEM HealthCare |
United States,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Quantify safety of ARDOXSO™, an interventional exosome therapy in COVID-19 in participants confirmed with SARS-CoV-2 infection who receive ARDOXSO™ as an intervention. | 90 Days | |
Primary | Tabulate and report the number of IMV days for patients receiving ARDOXSO™ perinatal MSC-derived exosome therapy. | Quantify efficacy of ARDOXSO™, an interventional exosome therapy in COVID-19 in participants confirmed with SARS-CoV-2 infection who receive ARDOXSO™ as an intervention. | 90 Days | |
Secondary | Analyze and report organ failure, associated with ICU mortality in participants confirmed with SARS-CoV2 infection, receiving ARDOXSO™ as an interventional exosome therapy. | Correlate and analyze the Sequential Organ Failure Assessment (SOFA) score in participants confirmed with SARS-CoV2 infection, receiving ARDOXSO™, an interventional exosome therapy in COVID-19 patients. An increased SOFA score is predictive of increased mortality. | 90 Days from last dose | |
Secondary | Record and analyze respiratory measures (Berlin Score/PEEP) following treatment regime. | Berlin Score is a validated measure of Acute Respiratory Distress Syndrome diagnosis, which is common in COVID-19 patients, before and after receiving the interventional exosome therapy, ARDOXSO™. | 90 Days from last dose |
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