Status:
UNKNOWN
Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Conditions:
SARS-CoV-2
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief 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 inf...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 25 2021
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04747574
Start Date
September 25 2020
End Date
March 25 2021
Last Update
March 4 2021
Active Locations (1)
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1
Tel Aviv Medical Center
Tel Aviv, Israel