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Trial record 3 of 3 for:    EXO-CD24

A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 Infection

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ClinicalTrials.gov Identifier: NCT04969172
Recruitment Status : Active, not recruiting
First Posted : July 20, 2021
Last Update Posted : July 20, 2021
Sponsor:
Collaborator:
OBCTCD24 Ltd
Information provided by (Responsible Party):
Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center

Brief Summary:

A Phase II Randomized, double-blind, Placebo-controlled Study to Evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration .The study population will include patients with moderate or severe COVID-19 infection and laboratory markers predictive of the cytokine storm from the Corona department of each site, who have provided an informed consent.

155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles (103 patients) or placebo (52 patients).The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days.

Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.


Condition or disease Intervention/treatment Phase
COVID-19 Disease Drug: Exosomes overexpressing CD24 Phase 2

Detailed Description:

The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days.

Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.

Study treatments will be given as add-on to standard of care. Following the 5 days of treatment, patients will remain in follow-up for 23 additional days. Patients who will be discharged before the end of the 5-day treatment period will continue to receive treatment at home. Treatment administration and the study assessments will be carried out by the research personnel at the home of the patient, implementing the required protective measures.

On Day 28, when the isolation period is completed, these patients will arrive at the study site for the follow-up visit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A Phase II Randomized, double-blind, Placebo-controlled Study to Evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration .The study population will include patients with moderate or severe COVID-19 infection and laboratory markers predictive of the cytokine storm from the Corona department of each site, who have provided an informed consent.
Masking: Double (Participant, Investigator)
Masking Description: 155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles -103 patients, or placebo- 52 patients.
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 Infection
Actual Study Start Date : July 11, 2021
Estimated Primary Completion Date : July 11, 2022
Estimated Study Completion Date : July 11, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1010 Exosome
103 patients will receive either 1010 exosome particles.
Drug: Exosomes overexpressing CD24
The suggested therapeutic agent here is based on an existing therapeutic platform that uses exosomes that were engineered to overexpress CD24 that can directly suppress the cytokine storm. The exosomes will be isolated and purified from human embryonic kidney T-REx™-293 cells that constitutively express high levels of human CD24.

Placebo Comparator: Placebo
52 patients will receive placebo- saline.
Drug: Exosomes overexpressing CD24
The suggested therapeutic agent here is based on an existing therapeutic platform that uses exosomes that were engineered to overexpress CD24 that can directly suppress the cytokine storm. The exosomes will be isolated and purified from human embryonic kidney T-REx™-293 cells that constitutively express high levels of human CD24.




Primary Outcome Measures :
  1. To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease [ Time Frame: One year ]
  2. To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19 disease [ Time Frame: One year ]
  3. To evaluate respiratory failure (defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high-flow oxygen devices) rate. [ Time Frame: One year ]
  4. To evaluate the death rate. [ Time Frame: One year ]
  5. To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower). [ Time Frame: One year ]
  6. To evaluate time from hospitalization to hospital discharge. [ Time Frame: One year ]
  7. To assess the COVID-19-related symptoms using patient-reported outcome measure (PRO) score. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. To evaluate the effect of EXO-CD24 on the respiratory rate. [ Time Frame: One year ]
  2. To evaluate the effect of EXO-CD24 on the change in blood oxygen saturation (SpO2). [ Time Frame: One year ]
  3. To evaluate the effect of EXO-CD24 on the proportion of patients requiring ventilation. [ Time Frame: One year ]
  4. To evaluate the effect of EXO-CD24 on the level of inflammatory markers (eg, CRP, ferritin, fibrinogen, di-dimers, IL-6, LDH, lymphocytes count. [ Time Frame: One year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A COVID-19 diagnosis confirmed with a SARS-coV-2 viral infection positive polymerase chain reaction (PCR) test
  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 >50% within 24-48 hours or a severe deterioration compared to imaging at admission b. Evidence of an exacerbated inflammatory process i. LDH score> 450 U/L ii. CRP >50 mg/L iii. Ferritin >1650 ng/ml iv. Lymphocytes >800 cells/mm3 v. D-dimers >1 mcg/ml

  4. Willing and able to sign an informed consent

Exclusion Criteria:

  1. Age<18 years or >80 years
  2. Any concomitant illness that, based on the judgment of the Investigator is terminal
  3. Ventilated patient
  4. Pregnancy (positive urine pregnancy test [women of childbearing potential only]) or breastfeeding
  5. Patients with Immunodeficiency (eg, CLL, HIV, rituximab therapy)
  6. Unwilling or unable to provide informed consent
  7. Participation in any other Interventional study in the last 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969172


Locations
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Israel
Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Eli Sprecher, MD
OBCTCD24 Ltd
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Responsible Party: Eli Sprecher, MD, Dr. Guy Choshen, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT04969172    
Other Study ID Numbers: 0206-21-TLV
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: July 20, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center:
AE- Adverse event
BUN - Blood urea nitrogen
CI- Confidence Interval
CMP - Clinical monitoring plan
CONSORT- Consolidated Standards of Reporting Trials
CRF - Case Report Form
DAMP- Damage-associated molecular patterns
DMEM- Dulbecco's Modified Eagle's Medium
GCP - Good Clinical Practice
GMP- Good Manufacturing Practice
GVHD- Graft-versus-host disease
HCT - Hematopoietic stem cell transplantation
ICH- International Conference on Harmonization
IDSA- Infectious Diseases Society of America
IRB- Institutional Review Board
ITT- Intend-to-Treat analysis set
mITT- Modified Intent-to-Treat analysis set
NLR - Neutrophil-to-lymphocyte ratio
PCR - Polymerase chain reaction
PI- Principal Investigator
PP- Per-Protocol analysis set
SA- Safety analysis set
SAE- Serious adverse event
SoA- Schedule of Activities
TLR- Toll-like receptors
Additional relevant MeSH terms:
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COVID-19
Clinical Deterioration
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Progression
Disease Attributes
Pathologic Processes