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

NCT04747574 | Unknown Phase 1 DMC

• 1 other identifier: 0254-20-TLV
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 infection and factors predictive of a cytokine storm are recruited from the Corona department of the Tel Aviv Sourasky Medical Center (TASMC), who have provided informed consent are being recruited in four dose groups who will receive the exosome treatment as an add-on treatment to standard treatment.

Conditions

SARS-CoV-2

Keywords

SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; COVID-19; Exosomes; ARDS; CD24; CD-24 exosomes

Outcome Measures

Primary Outcomes (1)

• Primary safety endpoint: Adverse events

  Number of adverse events, and adverse events leading to premature study termination.

  35 days

Secondary Outcomes (10)

• Exploratory Endpoint: Alive at Day 5 without bronchospasms, unexpected infections, or clinical deterioration

  5 days

• Exploratory Endpoint: Proportion of patients with respiratory rate ≤ 23/min for 24 hours

  5 days

• Exploratory endpoint: Change in respiratory rate from baseline to Day 5

  5 days

• Exploratory endpoint: Proportion of patients with SpO2 saturation ≥94% for at least 24 hours

  5 days

• Exploratory endpoint: Change in SpO2 saturation from baseline to Day 5

  5 days

Study Arms (1)

EXO-CD24 exosome treatment

OTHER

Group 1, 5 patients are treated with 1x10\^8 exosome particles per 2 ml saline. Group 2: 5 patients are treated with 5x10\^8 exosome particles per 2 ml saline. Group 3: 20 patients are treated with 1x10\^9 exosomes particles per 2 ml saline. Group 4: 5 patients are treated with 1x10\^10 exosomes particles per 2 ml saline. The drug is aerosolized in normal saline for inhalation and administered via a standard hospital-grade inhalation device, QD for 5 days. Study treatment is given as an add-on to the standard of care.

Drug: EXO-CD24

Interventions

EXO-CD24 DRUG

The study active treatment is EXO-CD24 -exosomes (natural nano-sized vesicles secreted by human cells) that were engineered to overexpress CD24, aerosolized in normal saline for inhalation via a standard hospital-grade inhalation device, QD for 5 days.

EXO-CD24 exosome treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

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

• Nadir Arber, Prof.

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadir Arber, Prof. MD MHA

CONTACT

972524266595; nadira@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nadir Arber MD, MSc, MHA Professor of Medicine and Gastroenterology. Head of the Health Promotion Center and the Integrated Cancer Prevention Center Tel-Aviv Sourasky Medical Center

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 10, 2021
• Study Start: September 25, 2020
• Primary Completion: February 25, 2021
• Study Completion: March 25, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)