Back to resultsA 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
Primary Purpose
COVID-19 Disease
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Exosomes overexpressing CD24
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Disease focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- A COVID-19 diagnosis confirmed with a SARS-coV-2 viral infection positive polymerase chain reaction (PCR) test
- 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 >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
- Willing and able to sign an informed consent
Exclusion Criteria:
- Age<18 years or >80 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
- Patients with Immunodeficiency (eg, CLL, HIV, rituximab therapy)
- Unwilling or unable to provide informed consent
- Participation in any other Interventional study in the last 30 days
Sites / Locations
- Tel-Aviv Sourasky Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1010 Exosome
Placebo
Arm Description
103 patients will receive either 1010 exosome particles.
52 patients will receive placebo- saline.
Outcomes
Primary Outcome Measures
To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease
To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19 disease
To evaluate respiratory failure (defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high-flow oxygen devices) rate.
To evaluate the death rate.
To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower).
To evaluate time from hospitalization to hospital discharge.
To assess the COVID-19-related symptoms using patient-reported outcome measure (PRO) score.
Secondary Outcome Measures
To evaluate the effect of EXO-CD24 on the respiratory rate.
To evaluate the effect of EXO-CD24 on the change in blood oxygen saturation (SpO2).
To evaluate the effect of EXO-CD24 on the proportion of patients requiring ventilation.
To evaluate the effect of EXO-CD24 on the level of inflammatory markers (eg, CRP, ferritin, fibrinogen, di-dimers, IL-6, LDH, lymphocytes count.
Full Information
NCT ID
NCT04969172
First Posted
July 18, 2021
Last Updated
July 18, 2021
Sponsor
Eli Sprecher, MD
Collaborators
OBCTCD24 Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04969172
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 11, 2021 (Actual)
Primary Completion Date
July 11, 2022 (Anticipated)
Study Completion Date
July 11, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Eli Sprecher, MD
Collaborators
OBCTCD24 Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Disease
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles -103 patients, or placebo- 52 patients.
Allocation
Randomized
Enrollment
155 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1010 Exosome
Arm Type
Active Comparator
Arm Description
103 patients will receive either 1010 exosome particles.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
52 patients will receive placebo- saline.
Intervention Type
Drug
Intervention Name(s)
Exosomes overexpressing CD24
Intervention Description
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 Measure Information:
Title
To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease
Time Frame
One year
Title
To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19 disease
Time Frame
One year
Title
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
Title
To evaluate the death rate.
Time Frame
One year
Title
To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower).
Time Frame
One year
Title
To evaluate time from hospitalization to hospital discharge.
Time Frame
One year
Title
To assess the COVID-19-related symptoms using patient-reported outcome measure (PRO) score.
Time Frame
One year
Secondary Outcome Measure Information:
Title
To evaluate the effect of EXO-CD24 on the respiratory rate.
Time Frame
One year
Title
To evaluate the effect of EXO-CD24 on the change in blood oxygen saturation (SpO2).
Time Frame
One year
Title
To evaluate the effect of EXO-CD24 on the proportion of patients requiring ventilation.
Time Frame
One year
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A COVID-19 diagnosis confirmed with a SARS-coV-2 viral infection positive polymerase chain reaction (PCR) test
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 >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
Willing and able to sign an informed consent
Exclusion Criteria:
Age<18 years or >80 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
Patients with Immunodeficiency (eg, CLL, HIV, rituximab therapy)
Unwilling or unable to provide informed consent
Participation in any other Interventional study in the last 30 days
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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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