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

Launched by TEL-AVIV SOURASKY MEDICAL CENTER · Feb 9, 2021

Keywords

ClinConnect Summary

Coronavirus disease 2019 (COVID-19) is a highly transmissible disease in the community. The main cause of clinical deterioration that leads to death is the cytokine storm in the lung.

CD24 is a small heavily glycosylated GPI-anchored protein. CD24 is a key player in the vast majority of human cancers and also plays an important role in controlling the homeostatic proliferation of T cells. Hence, CD24 can negatively regulate inflammation.

The treatment is a biologic therapeutic agent based on exosomes carrying CD24. The rationale for this treatment is that exosomes overexpressing CD24, iso...

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Eligibility 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