Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection

• Status: Recruiting
• Trial end date: 2021-03-25
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label Phase I study, four dose escalation groups, to evaluate the safety of CD24-exosomes in patients with moderate/severe COVID-19 disease.

Patients with moderate/severe COVID-19 infection and factors predictive of a cytokine storm are recruited from the Corona department of the Tel Aviv Sourasky Medical Center (TASMC), who have provided informed consent are being recruited in four dose groups who will receive the exosome treatment as an add-on treatment to standard treatment.

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

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Criteria

1. A COVID-19 diagnosis confirmed with a SARS-CoV-2 viral infection positive polymerase chain reaction (PCR) test

2. Disease severity: Moderate/severe according to the following criteria (at least one clinical parameter and one laboratory parameter are required):

1. 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

2. 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

3. Willing and able to sign an informed consent

Exclusion Criteria:

1. Age<18 years or >85 years

2. Any concomitant illness that, based on the judgment of the Investigator is terminal

3. Ventilated patient

4. Pregnancy (positive urine pregnancy test [women of childbearing potential only]) or breastfeeding

5. Unwilling or unable to provide informed consent

6. Participation in any other study in the last 30 days