Safety and Efficacy of Exosomes Overexpressing CD24 in Two Doses for Patients With Moderate or Severe COVID-19
Covid19
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- A COVID-19 diagnosis confirmed with a SARS-CoV-2 infection positive polymerase chain reaction (PCR) within 30 days of screening.
- Age 18-80 years.
Severity of disease according to the following criteria (at least one clinical parameter and one laboratory parameter are required):
a. Clinical and Imaging-based evaluation i. Respiratory rate > 23/min and < 30/min ii. SpO2 at room air ≤94% and ≥90% iii. Bilateral pulmonary infiltrates >25% within 24-48 hours or a severe deterioration compared to imaging at admission.
b. Evidence of an exacerbated inflammatory process i. LDH > 300 U/L or what is the upper limit for normal per age ii. CRP >25 mg/L iii. Ferritin >500 ng/ml iv. Lymphocytes <800 cells/mm3 v. D-dimers > 500ng/ml
- Willing and able to sign an informed consent.
Exclusion Criteria:
- Any concomitant illness that, based on the judgment of the Investigator might affect the interpretation or the results of the study (i.e., immunodeficiency).
- Mechanically-ventilated patient or patient who will probably require ICU admission or mechanical ventilation within 24 hours from enrolment, according to the Investigator's judgment.
- Previous complete or partial vaccination for SARS-CoV-2.
- Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding.
- Participation in any other Interventional study in the last 30 days
- Active cancer.
Sites / Locations
- 3rd Department of Medicine, "Sotiria" Thoracic Diseases General Hospital of Athens
- Attikon University HospitalRecruiting
- 7th Respiratory Medicine Department, "Sotiria" Thoracic Diseases General Hospital of Athens
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
10^9 dose of exosomes overexpressing CD24
10^10 dose of exosomes overexpressing CD24
The patients will receive the dose of 10^9 exosomes overexpressing CD24
The patients will receive the dose of 10^10 exosomes overexpressing CD24