Safety and Efficacy of Exosomes Overexpressing CD24 in Two Doses for Patients With Moderate or Severe COVID-19

NCT04902183 | Unknown Phase 2

• 1 other identifier: NS3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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\^10 exosome particles (per dose), to prevent clinical deterioration in patients with Moderate or Severe COVID-19 infection.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• Collection of serious adverse events

  * Incidence of treatment (dose)-related serious adverse events. * Incidence of all adverse events related or unrelated to the study treatment.

  Through study completion, an average of 4 months

• Proportion of patients related with Respiratory rate and SpO2 saturation

  * Proportion of patients with respiratory rate \< 23/min for at least 24 hours, on Day 7. * Proportion of patients with SpO2 saturation \>94%, on room air for at least 24 hours, on Day 7. * Proportion of patients with a decrease by 50% in either CRP/LDH/Fibrinogen/Ferritin/D-dimers from baseline to Day 7.

  Through study completion, an average of 4 months

Secondary Outcomes (23)

• Improvement of COVID19 status from severe to moderate

  Through study completion, an average of 4 months

• Time to recovery

  Through study completion, an average of 4 months

• Death rate

  Through study completion, an average of 4 months

• No need for mechanical ventilation

  Through study completion, an average of 4 months

• Patients status regarding haemodynamic instability

  Through study completion, an average of 4 months

Study Arms (2)

10^9 dose of exosomes overexpressing CD24

EXPERIMENTAL

The patients will receive the dose of 10\^9 exosomes overexpressing CD24

Drug: CovenD24

10^10 dose of exosomes overexpressing CD24

EXPERIMENTAL

The patients will receive the dose of 10\^10 exosomes overexpressing CD24

Drug: CovenD24

Interventions

CovenD24 DRUG

The drug will be administrated once daily for 5 days

Also known as: Exo-CD24

10^10 dose of exosomes overexpressing CD24; 10^9 dose of exosomes overexpressing CD24

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Athens Medical Society: lead
• OBCTCD24 Ltd: collaborator
• Elpen Pharmaceutical Co. Inc.: collaborator

Study Sites (3)

3rd Department of Medicine, "Sotiria" Thoracic Diseases General Hospital of Athens

Athens, Attica, 11527, Greece

NOT YET RECRUITING

7th Respiratory Medicine Department, "Sotiria" Thoracic Diseases General Hospital of Athens

Athens, Attica, 11527, Greece

NOT YET RECRUITING

Attikon University Hospital

Athens, Attica, 12462, Greece

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sotirios Tsiodras, Prof

  Attikon University Hospital, Athens, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sotirios Tsiodras, Prof

CONTACT

0030-210-5831990; stsiodras.office@gmail.com

Nadir Arber, Prof

CONTACT

nadira@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The administrated dose will be unknown to the patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two arms study; one arm will receive 10\^9 dose and the second arm will receive 10\^10 dose of exosomes overexpressing CD24

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 26, 2021
• Study Start: June 9, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3)