SARS-CoV-2Phase 1NCT04747574
Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection
A Phase 1 study testing EXO-CD24 in people with SARS-CoV-2, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- EXO-CD24
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Sep 2020to 25 Mar 2021
- Phase
- Phase 1
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Medical Center
Tel Aviv
Nadir Arber, Prof., nadira@tlvmc.gov.il
About this study
Official title: A Phase I Feasibility Study to Evaluate the Safety of CD24-Exosomes in Patients With Moderate/Severe COVID-19 Infection
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.
Read the detailed description
Coronavirus disease 2019 (COVID-19) is a highly transmissible disease in the community. The main cause of clinical deterioration that leads to death is the cytokine storm in the lung.
CD24 is a small heavily glycosylated GPI-anchored protein. CD24 is a key player in the vast majority of human cancers and also plays an important role in controlling the homeostatic proliferation of T cells. Hence, CD24 can negatively regulate inflammation.
The treatment is a biologic therapeutic agent based on exosomes carrying CD24. The rationale for this treatment is that exosomes overexpressing CD24, isolated and purified from T-REx™-293 cells engineered to express CD24 at high levels, can suppress the cytokine storm and are delivered directly to the target organ using exosomes as a highly body-compatible delivery vehicle. This enables a strong reduction of the required dose (as opposed to systemic administration), and reduces the risk for adverse events.
- Conditions
- SARS-CoV-2
- Being tested
- EXO-CD24
- Keywords
- SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, COVID-19, Exosomes, ARDS, CD24, CD-24 exosomes
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXO-CD24Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: EXO-CD24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary safety endpoint: Adverse events
Number of adverse events, and adverse events leading to premature study termination.
Measured: 35 days
Secondary outcomes (10)
Exploratory Endpoint: Alive at Day 5 without bronchospasms, unexpected infections, or clinical deterioration
A composite endpoint comprised of alive at Day 5 without bronchospasms, unexpected infections, or a significant clinical deterioration compared to Baseline
Measured: 5 days
Exploratory Endpoint: Proportion of patients with respiratory rate ≤ 23/min for 24 hours
Proportion of patients with respiratory rate ≤ 23/min for 24 hours
Measured: 5 days
Exploratory endpoint: Change in respiratory rate from baseline to Day 5
Change in respiratory rate from baseline to Day 5
Measured: 5 days
Exploratory endpoint: Proportion of patients with SpO2 saturation ≥94% for at least 24 hours
Proportion of patients with SpO2 saturation ≥94% for at least 24 hours
Measured: 5 days
Exploratory endpoint: Change in SpO2 saturation from baseline to Day 5
Change in SpO2 saturation from baseline to Day 5
Measured: 5 days
Exploratory endpoint: Proportion of patients with no artificial ventilation after 5 days of treatment
Proportion of patients with no artificial ventilation after 5 days of treatment
Measured: 5 days
Exploratory endpoint: Proportion of patients with a change in absolute lymphocyte count, sustained for ≥48 hours after 5 days of treatment
Proportion of patients with a change in the absolute lymphocyte count, sustained for ≥48 hours after 5 days of treatment
Measured: 7 days
Exploratory endpoint: Change in the absolute lymphocyte count from baseline to Day 5
Change in the absolute lymphocyte count from baseline to Day 5
Measured: 5 days
Exploratory endpoint: Change in neutrophil-to-lymphocyte ratio (NLR), sustained for ≥48 hours after 5 days of treatment
Proportion of patients with a change in the neutrophil-to-lymphocyte ratio, sustained for ≥48 hours after 5 days of treatment
Measured: 7 days
Exploratory endpoint: Change in neutrophil-to-lymphocyte ratio (NLR) from baseline to Day 5
Change in neutrophil-to-lymphocyte ratio (NLR) from baseline to Day 5
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start25 Sep 2020
- Primary completion25 Feb 2021 (estimated)
- Study completion25 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- Nadir Arber, Prof., Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747574
- Sponsor's protocol ID
- 0254-20-TLV
- Status last verified
- Mar 2021
- First submitted
- 26 Jan 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Feasibility Study to Evaluate the Safety of CD24-Exosomes in Patients With Moderate/Severe COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04747574
- Acronym / sponsor ID
- 0254-20-TLV
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, COVID-19, Exosomes, ARDS, CD24, CD-24 exosomes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 25 Feb 2021 (estimated)
- Study completion
- 25 Mar 2021 (estimated)
- First posted
- 10 Feb 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.
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.
Detailed description
Coronavirus disease 2019 (COVID-19) is a highly transmissible disease in the community. The main cause of clinical deterioration that leads to death is the cytokine storm in the lung.
CD24 is a small heavily glycosylated GPI-anchored protein. CD24 is a key player in the vast majority of human cancers and also plays an important role in controlling the homeostatic proliferation of T cells. Hence, CD24 can negatively regulate inflammation.
The treatment is a biologic therapeutic agent based on exosomes carrying CD24. The rationale for this treatment is that exosomes overexpressing CD24, isolated and purified from T-REx™-293 cells engineered to express CD24 at high levels, can suppress the cytokine storm and are delivered directly to the target organ using exosomes as a highly body-compatible delivery vehicle. This enables a strong reduction of the required dose (as opposed to systemic administration), and reduces the risk for adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXO-CD24 exosome treatment | Other | Drug: EXO-CD24Group 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| EXO-CD24The 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. | Drug | EXO-CD24 exosome treatment |
Primary outcome
Primary safety endpoint: Adverse events
Time frame: 35 days
Number of adverse events, and adverse events leading to premature study termination.
10 secondary outcomes
Exploratory Endpoint: Alive at Day 5 without bronchospasms, unexpected infections, or clinical deterioration
Time frame: 5 days
Exploratory Endpoint: Proportion of patients with respiratory rate ≤ 23/min for 24 hours
Time frame: 5 days
Exploratory endpoint: Change in respiratory rate from baseline to Day 5
Time frame: 5 days
Exploratory endpoint: Proportion of patients with SpO2 saturation ≥94% for at least 24 hours
Time frame: 5 days
Exploratory endpoint: Change in SpO2 saturation from baseline to Day 5
Time frame: 5 days
Exploratory endpoint: Proportion of patients with no artificial ventilation after 5 days of treatment
Time frame: 5 days
Exploratory endpoint: Proportion of patients with a change in absolute lymphocyte count, sustained for ≥48 hours after 5 days of treatment
Time frame: 7 days
Exploratory endpoint: Change in the absolute lymphocyte count from baseline to Day 5
Time frame: 5 days
Exploratory endpoint: Change in neutrophil-to-lymphocyte ratio (NLR), sustained for ≥48 hours after 5 days of treatment
Time frame: 7 days
Exploratory endpoint: Change in neutrophil-to-lymphocyte ratio (NLR) from baseline to Day 5
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
- 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.
Nadir Arber, Prof. principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EXO-CD24 in people with SARS-CoV-2, run by Tel-Aviv Sourasky Medical Center 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 0 inclusion and 6 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 4 Mar 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Nadir Arber, Prof. MD MHA (972524266595 ext. 0, nadira@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint: Adverse events (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2021.