COVID-19 DiseasePhase 2NCT04969172
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
A Phase 2 study testing Exosomes overexpressing CD24 in people with COVID-19 Disease, run by Eli Sprecher, MD at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Disease
- What is being tested?
- Exosomes overexpressing CD24
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Jul 2021to 11 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COVID-19 Disease
- Being tested
- Exosomes overexpressing CD24
- 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
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exosomes overexpressing CD24Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1010 Exosome | Active comparator | 103 patients will receive either 1010 exosome particles. Receives: Drug: Exosomes overexpressing CD24 |
| Placebo | Placebo comparator | 52 patients will receive placebo- saline. Receives: Drug: Exosomes overexpressing CD24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease
Measured: One year
To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19 disease
Measured: One year
To evaluate respiratory failure (defined as the need for mechanical ventilation, ECMO, non-invasive ventilation, or high-flow oxygen devices) rate.
Measured: One year
To evaluate the death rate.
Measured: One year
To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower).
Measured: One year
To evaluate time from hospitalization to hospital discharge.
Measured: One year
To assess the COVID-19-related symptoms using patient-reported outcome measure (PRO) score.
Measured: One year
Secondary outcomes (4)
To evaluate the effect of EXO-CD24 on the respiratory rate.
Measured: One year
To evaluate the effect of EXO-CD24 on the change in blood oxygen saturation (SpO2).
Measured: One year
To evaluate the effect of EXO-CD24 on the proportion of patients requiring ventilation.
Measured: One year
To evaluate the effect of EXO-CD24 on the level of inflammatory markers (eg, CRP, ferritin, fibrinogen, di-dimers, IL-6, LDH, lymphocytes count.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start11 Jul 2021
- Primary completion11 Jul 2022 (estimated)
- Study completion11 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Sprecher, MD
- Sponsor type
- Other government
- Collaborators
- OBCTCD24 Ltd
- Responsible party
- Sponsor-investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969172
- Sponsor's protocol ID
- 0206-21-TLV
- Status last verified
- Jul 2021
- First submitted
- 18 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pala M, Yilmaz SG. Circular RNAs, miRNAs, and Exosomes: Their Roles and Importance in Amyloid-Beta and Tau Pathologies in Alzheimer's Disease. Neural Plast. 2025 Apr 8;2025:9581369. doi: 10.1155/np/9581369. eCollection 2025.
PubMed 40235521
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04969172
- Acronym / sponsor ID
- 0206-21-TLV
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Eli Sprecher, MDOther government
- Collaborators
- OBCTCD24 Ltd
- Study start
- 11 Jul 2021 (actual)
- Primary completion
- 11 Jul 2022 (estimated)
- Study completion
- 11 Jul 2022 (estimated)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 1010 Exosome | Active comparator | Drug: Exosomes overexpressing CD24103 patients will receive either 1010 exosome particles. |
| Placebo | Placebo comparator | Drug: Exosomes overexpressing CD2452 patients will receive placebo- saline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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):
- Willing and able to sign an informed consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exosomes overexpressing CD24The 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. | Drug | 1010 Exosome, Placebo |
Primary outcome
To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease
Time frame: One year
To assess the efficacy of EXO-CD24 in the clinical improvement of COVID-19 disease
Time frame: One year
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
To evaluate the death rate.
Time frame: One year
To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower).
Time frame: One year
To evaluate time from hospitalization to hospital discharge.
Time frame: One year
To assess the COVID-19-related symptoms using patient-reported outcome measure (PRO) score.
Time frame: One year
4 secondary outcomes
To evaluate the effect of EXO-CD24 on the respiratory rate.
Time frame: One year
To evaluate the effect of EXO-CD24 on the change in blood oxygen saturation (SpO2).
Time frame: One year
To evaluate the effect of EXO-CD24 on the proportion of patients requiring ventilation.
Time frame: One year
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Derived from this study: PubMed 40235521Pala M, Yilmaz SG. Circular RNAs, miRNAs, and Exosomes: Their Roles and Importance in Amyloid-Beta and Tau Pathologies in Alzheimer's Disease. Neural Plast. 2025 Apr 8;2025:9581369. doi: 10.1155/np/9581369. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exosomes overexpressing CD24 in people with COVID-19 Disease, run by Eli Sprecher, MD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease (time frame: One year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04969172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.