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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2021-09-01

Brief Summary

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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.

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Detailed Description

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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 randomized in a 1:1 ratio to receive either 109 exosome particles (45 patients) or 1010 exosome particles (45 patients).

The exosomes will be diluted in normal saline for inhalation via mouthpiece nebulization, administered once daily (QD) for 5 days.

Study treatments will be given as an add-on to the standard of care. Following the 5 days of treatment, patients will remain in follow-up for 23 additional days. In case of hospital discharge before the full follow-up planned, the patient will be required to return to the site for completion of all study assessments.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The administrated dose will be unknown to the patients

Study Groups

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10^9 dose of exosomes overexpressing CD24

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

Group Type EXPERIMENTAL

CovenD24

Intervention Type DRUG

The drug will be administrated once daily for 5 days

10^10 dose of exosomes overexpressing CD24

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

Group Type EXPERIMENTAL

CovenD24

Intervention Type DRUG

The drug will be administrated once daily for 5 days

Interventions

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CovenD24

The drug will be administrated once daily for 5 days

Intervention Type DRUG

Other Intervention Names

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Exo-CD24

Eligibility Criteria

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Inclusion Criteria

1. A COVID-19 diagnosis confirmed with a SARS-CoV-2 infection positive polymerase chain reaction (PCR) within 30 days of screening.
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 \>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
4. Willing and able to sign an informed consent.

Exclusion Criteria

1. Any concomitant illness that, based on the judgment of the Investigator might affect the interpretation or the results of the study (i.e., immunodeficiency).
2. 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.
3. Previous complete or partial vaccination for SARS-CoV-2.
4. Pregnancy \[positive urine pregnancy test (women of childbearing potential only)\] or breastfeeding.
5. Participation in any other Interventional study in the last 30 days
6. Active cancer.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No