Overview

A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 Infection

Status:
Active, not recruiting
Trial end date:
2022-07-11
Target enrollment:
0
Participant gender:
All
Summary
A Phase II Randomized, double-blind, Placebo-controlled Study to Evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration .The study population will include patients with moderate or severe COVID-19 infection and laboratory markers predictive of the cytokine storm from the Corona department of each site, who have provided an informed consent. 155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles (103 patients) or placebo (52 patients).The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days. Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Sprecher, MD
Collaborator:
OBCTCD24 Ltd
Criteria
Inclusion Criteria:

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

2. Age 18-80 years

3. 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 >50% within 24-48
hours or a severe deterioration compared to imaging at admission b. Evidence of an
exacerbated inflammatory process i. LDH score> 450 U/L ii. CRP >50 mg/L iii. Ferritin
>1650 ng/ml iv. Lymphocytes >800 cells/mm3 v. D-dimers >1 mcg/ml

4. Willing and able to sign an informed consent

Exclusion Criteria:

1. Age<18 years or >80 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. Patients with Immunodeficiency (eg, CLL, HIV, rituximab therapy)

6. Unwilling or unable to provide informed consent

7. Participation in any other Interventional study in the last 30 days