Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection
SARS-CoV-2
About this trial
This is an interventional treatment trial for SARS-CoV-2 focused on measuring SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, COVID-19, Exosomes, ARDS, CD24, CD-24 exosomes
Eligibility Criteria
- A COVID-19 diagnosis confirmed with a SARS-CoV-2 viral infection positive polymerase chain reaction (PCR) test
Disease severity: Moderate/severe according to the following criteria (at least one clinical parameter and one laboratory parameter are required):
Clinical and Imaging-based evaluation
- Respiratory rate > 23/ min and < 30/min
- SpO2 at room air ≤94% and ≥90%
- Bilateral pulmonary infiltrates >50% within 24-48 hours or a severe deterioration compared to imaging at admission
Evidence of an exacerbated inflammatory process
- LDH score > 450 u/L
- CRP >100 u/L
- Ferritin >1650 ng/ml
- Lymphopenia <800 cells/mm3 v. D-dimers>1
- Willing and able to sign an informed consent
Exclusion Criteria:
- Age<18 years or >85 years
- Any concomitant illness that, based on the judgment of the Investigator is terminal
- Ventilated patient
- Pregnancy (positive urine pregnancy test [women of childbearing potential only]) or breastfeeding
- Unwilling or unable to provide informed consent
- Participation in any other study in the last 30 days
Sites / Locations
- Tel Aviv Medical CenterRecruiting
Arms of the Study
Arm 1
Other
EXO-CD24 exosome treatment
Group 1, 5 patients are treated with 1x10^8 exosome particles per 2 ml saline. Group 2: 5 patients are treated with 5x10^8 exosome particles per 2 ml saline. Group 3: 20 patients are treated with 1x10^9 exosomes particles per 2 ml saline. Group 4: 5 patients are treated with 1x10^10 exosomes particles per 2 ml saline. The drug is aerosolized in normal saline for inhalation and administered via a standard hospital-grade inhalation device, QD for 5 days. Study treatment is given as an add-on to the standard of care.