Status:
UNKNOWN
Safety and Efficacy of Exosomes Overexpressing CD24 in Two Doses for Patients With Moderate or Severe COVID-19
Lead Sponsor:
Athens Medical Society
Collaborating Sponsors:
OBCTCD24 Ltd
Elpen Pharmaceutical Co. Inc.
Conditions:
Covid19
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a phase II randomized, single-blind dose study to evaluate the safety and efficacy of exosomes overexpressing CD24 of two doses, Dose 1 - 10\^9 exosome particles (per dose) versus Dose 2 - 10\...
Detailed Description
The study population will include patients with moderate or severe COVID-19 and laboratory markers predictive of the cytokine storm, who have provided an informed consent. 90 patients will be randomi...
Eligibility Criteria
Inclusion
- A COVID-19 diagnosis confirmed with a SARS-CoV-2 infection positive polymerase chain reaction (PCR) within 30 days of screening.
- Age 18-80 years.
- 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 \>25% within 24-48 hours or a severe deterioration compared to imaging at admission.
- b. Evidence of an exacerbated inflammatory process i. LDH \> 300 U/L or what is the upper limit for normal per age ii. CRP \>25 mg/L iii. Ferritin \>500 ng/ml iv. Lymphocytes \<800 cells/mm3 v. D-dimers \> 500ng/ml
- Willing and able to sign an informed consent.
Exclusion
- Any concomitant illness that, based on the judgment of the Investigator might affect the interpretation or the results of the study (i.e., immunodeficiency).
- Mechanically-ventilated patient or patient who will probably require ICU admission or mechanical ventilation within 24 hours from enrolment, according to the Investigator's judgment.
- Previous complete or partial vaccination for SARS-CoV-2.
- Pregnancy \[positive urine pregnancy test (women of childbearing potential only)\] or breastfeeding.
- Participation in any other Interventional study in the last 30 days
- Active cancer.
Key Trial Info
Start Date :
June 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04902183
Start Date
June 9 2021
End Date
September 1 2021
Last Update
June 15 2021
Active Locations (3)
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1
3rd Department of Medicine, "Sotiria" Thoracic Diseases General Hospital of Athens
Athens, Attica, Greece, 11527
2
7th Respiratory Medicine Department, "Sotiria" Thoracic Diseases General Hospital of Athens
Athens, Attica, Greece, 11527
3
Attikon University Hospital
Athens, Attica, Greece, 12462