Covid19Phase 2NCT04902183
Safety and Efficacy of Exosomes Overexpressing CD24 in Two Doses for Patients With Moderate or Severe COVID-19
A Phase 2 study testing CovenD24 in people with Covid19, run by Athens Medical Society at 3 sites in Greece.
Trial summary
This is a phase II randomized, single-blind dose study to evaluate the safety and efficacy of exosomes overexpressing CD24 of two doses, Dose 1 - 10^9 exosome particles (per dose) versus Dose 2 - 10^10 exosome particles (per dose), to prevent clinical deterioration in patients with Moderate or Severe COVID-19… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- CovenD24
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesGreece
- Study dates
- 9 Jun 2021to 1 Sep 2021
- 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 infection positive polymerase chain reaction (PCR) within 30 days of screening.
- 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 >25% within 24-48 hours or a severe deterioration compared to imaging at admission.
- Evidence of an exacerbated inflammatory process i. LDH > 300 U/L or what is the upper limit for normal per age ii. CRP >25 mg/L iii. Ferritin >500 ng/ml iv. Lymphocytes <800 cells/mm3 v. D-dimers > 500ng/ml
- Willing and able to sign an informed consent.
Who cannot join
- Any concomitant illness that, based on the judgment of the Investigator might affect the interpretation or the results of the study (i.e., immunodeficiency).
- Mechanically-ventilated patient or patient who will probably require ICU admission or mechanical ventilation within 24 hours from enrolment, according to the Investigator's judgment.
- Previous complete or partial vaccination for SARS-CoV-2.
- Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding.
- Participation in any other Interventional study in the last 30 days
- Active cancer.
Trial locations and contacts
3 sites in 1 country.
Nadir Arber, Prof contact
Greece3 sites, 3 recruiting
- Not yet recruiting
3rd Department of Medicine, "Sotiria" Thoracic Diseases General Hospital of Athens
Athens, Attica, 11527
Garyfallia Poulakou, Ass. Prof, 0030-210-7763439
- Not yet recruiting
7th Respiratory Medicine Department, "Sotiria" Thoracic Diseases General Hospital of Athens
Athens, Attica, 11527
Mina Gaga, Director, 0030-210-7781720, 7th_klin@otenet.gr
- Recruiting
Attikon University Hospital
Athens, Attica, 12462
Sotirios Tsiodras, Prof, 210-5831990, stsiodras.office@gmail.com
About this study
Official title: A Phase II Randomized, Single-blind Dose Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 in 10^9 Dose Versus 10^10 Dose, for the Prevention of Clinical Deterioration in Patients With Moderate or Severe COVID-19
This is a phase II randomized, single-blind dose study to evaluate the safety and efficacy of exosomes overexpressing CD24 of two doses, Dose 1 - 10^9 exosome particles (per dose) versus Dose 2 - 10^10 exosome particles (per dose), to prevent clinical deterioration in patients with Moderate or Severe COVID-19 infection.
Read the detailed description
The study population will include patients with moderate or severe COVID-19 and laboratory markers predictive of the cytokine storm, who have provided an informed consent.
90 patients will be randomized in a 1:1 ratio to receive either 109 exosome particles (45 patients) or 1010 exosome particles (45 patients).
The exosomes will be diluted in normal saline for inhalation via mouthpiece nebulization, administered once daily (QD) for 5 days.
Study treatments will be given as an add-on to the standard of care. Following the 5 days of treatment, patients will remain in follow-up for 23 additional days. In case of hospital discharge before the full follow-up planned, the patient will be required to return to the site for completion of all study assessments.
- Conditions
- Covid19
- Being tested
- CovenD24
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CovenD24Drug
Also called Exo-CD24
The drug will be administrated once daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 10^9 dose of exosomes overexpressing CD24 | Experimental | The patients will receive the dose of 10^9 exosomes overexpressing CD24 Receives: Drug: CovenD24 |
| 10^10 dose of exosomes overexpressing CD24 | Experimental | The patients will receive the dose of 10^10 exosomes overexpressing CD24 Receives: Drug: CovenD24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of serious adverse events
- Incidence of treatment (dose)-related serious adverse events.
- Incidence of all adverse events related or unrelated to the study treatment.
Measured: Through study completion, an average of 4 months
Proportion of patients related with Respiratory rate and SpO2 saturation
- Proportion of patients with respiratory rate < 23/min for at least 24 hours, on Day 7.
- Proportion of patients with SpO2 saturation >94%, on room air for at least 24 hours, on Day 7.
- Proportion of patients with a decrease by 50% in either CRP/LDH/Fibrinogen/Ferritin/D-dimers from baseline to Day 7.
Measured: Through study completion, an average of 4 months
Secondary outcomes (23)
Improvement of COVID19 status from severe to moderate
- Rate of categorical and absolute score improvement of COVID-19 status on Day 7 improving from "Severe" to at least "Moderate" or from "Moderate" to "Moderate-Mild"
Measured: Through study completion, an average of 4 months
Time to recovery
- Time to recovery, measured from enrolment (Day 1) to recovery or last follow-up (Day 28).
Measured: Through study completion, an average of 4 months
Death rate
- Death rate at end of study (Day 28)
Measured: Through study completion, an average of 4 months
No need for mechanical ventilation
- Proportion of patients with no mechanical ventilation (ECMO, NIV, high flow) on Day 7.
Measured: Through study completion, an average of 4 months
Patients status regarding haemodynamic instability
- Proportion of patients with haemodynamic instability or requiring vasopressors on Day 7.
Measured: Through study completion, an average of 4 months
Oxygen saturation
- Change in the SpO2/FiO2 ratio on Day 7.
Measured: Through study completion, an average of 4 months
Time to death or respiratory failure
- Time to death or respiratory failure (defined as an arterial oxygen pressure (PaO2) of <60 mmHg and/or an arterial carbon dioxide pressure (PaCO2) of >45 mmHg, or the need for mechanical ventilation, ECMO, non-invasive ventilation, or high-flow oxygen devices) within 28 days of the study period (Day 1 to Day 28).
Measured: Through study completion, an average of 4 months
Hospital discharge time
- Hospital discharge time within 28 days of the study period, calculated from the day of randomization (Day 1) to discharge or last follow-up (Day 28), whichever comes first.
Measured: Through study completion, an average of 4 months
No of patients that will need Intensive Care Unit
- Proportion of patients requiring admission to an Intensive-Care Unit (ICU) on Day 7.
Measured: Through study completion, an average of 4 months
No of patients with respiratory rate < 23/min
- Proportion of patients with respiratory rate < 23/min for 24 hours at every visit until Day 28, inclusive.
Measured: Through study completion, an average of 4 months
No of patients with change in respiratory change
- Proportion of patients with change [decrease/no change (±2 breaths/min)/improvement] in respiratory rate from baseline to Day 7.
Measured: Through study completion, an average of 4 months
No of patients with SpO2 >94%
- Proportion of patients with SpO2 >94% on room air, for at least 24 hours at every visit until Day 28, inclusive.
Measured: Through study completion, an average of 4 months
No of patients with change in oxygen saturation
- Proportion of patients with change [decrease/no change (±2 %)/improvement] in SpO2 saturation from baseline to Day 7.
Measured: Through study completion, an average of 4 months
No of patients with change in lymphocyte count
- Proportion of patients with an increase of 25% in the absolute lymphocyte count, sustained for ≥24 hours on Day 7.
Measured: Through study completion, an average of 4 months
Changes in absolute lymphocyte count
- Change in absolute lymphocyte count from baseline to Day 7.
Measured: Through study completion, an average of 4 months
No of patients with changes in the neutrophil-to-lymphocyte ratio
- Proportion of patients with a decrease of 20% in the neutrophil-to-lymphocyte ratio (NLR), sustained for ≥24 hours on Day 7.
Measured: Through study completion, an average of 4 months
Changes in the neutrophil-to-lymphocyte ratio
- Change in NLR from baseline to Day 7.
Measured: Through study completion, an average of 4 months
No of patients with changes in disease severity
- Percentage of patients within each severity rating on the ordinal scale within 28 days of the study period (Day 1 to Day 28).
Measured: Through study completion, an average of 4 months
Time of disease improvement
- Time to improvement in the categorical and ordinal scale, measured from randomization (Day 1) to last study follow-up (Day 28).
Measured: Through study completion, an average of 4 months
Changes in COVID-19 clinical severity
- Change in the COVID-19 clinical severity from baseline [before-treatment assessment (Screening/Day 1)] up to Day 28.
Measured: Through study completion, an average of 4 months
Changes in common COVID-19 related symptoms
- Change from baseline of 14 Common COVID-19-Related Symptoms, as assessed through an Investigator interview.
Measured: Through study completion, an average of 4 months
Changes in supplemental oxygen over time
- Change in the flow rate of supplemental oxygen administration over time.
Measured: Through study completion, an average of 4 months
Duration of oxygen administration
- The duration of supplemental (non-invasive) oxygen administration.
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start9 Jun 2021
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- This is a two arms study; one arm will receive 10\^9 dose and the second arm will receive 10\^10 dose of exosomes overexpressing CD24
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Athens Medical Society
- Sponsor type
- University, hospital or other
- Collaborators
- OBCTCD24 Ltd, Elpen Pharmaceutical Co. Inc.
- Responsible party
- Sponsor
- Investigators
- Sotirios Tsiodras, Prof, Principal investigator, Attikon University Hospital, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902183
- Sponsor's protocol ID
- NS3
- Status last verified
- Jun 2021
- First submitted
- 21 May 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Single-blind Dose Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 in 10^9 Dose Versus 10^10 Dose, for the Prevention of Clinical Deterioration in Patients With Moderate or Severe COVID-19
- ClinicalTrials.gov ID
- NCT04902183
- Acronym / sponsor ID
- NS3
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Athens Medical SocietyUniversity, hospital or other
- Collaborators
- OBCTCD24 Ltd, Elpen Pharmaceutical Co. Inc.
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 26 May 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 a phase II randomized, single-blind dose study to evaluate the safety and efficacy of exosomes overexpressing CD24 of two doses, Dose 1 - 10^9 exosome particles (per dose) versus Dose 2 - 10^10 exosome particles (per dose), to prevent clinical deterioration in patients with Moderate or Severe COVID-19 infection.
Detailed description
The study population will include patients with moderate or severe COVID-19 and laboratory markers predictive of the cytokine storm, who have provided an informed consent.
90 patients will be randomized in a 1:1 ratio to receive either 109 exosome particles (45 patients) or 1010 exosome particles (45 patients).
The exosomes will be diluted in normal saline for inhalation via mouthpiece nebulization, administered once daily (QD) for 5 days.
Study treatments will be given as an add-on to the standard of care. Following the 5 days of treatment, patients will remain in follow-up for 23 additional days. In case of hospital discharge before the full follow-up planned, the patient will be required to return to the site for completion of all study assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a two arms study; one arm will receive 10^9 dose and the second arm will receive 10^10 dose of exosomes overexpressing CD24
| Arm | Type | Receives |
|---|---|---|
| 10^9 dose of exosomes overexpressing CD24 | Experimental | Drug: CovenD24The patients will receive the dose of 10^9 exosomes overexpressing CD24 |
| 10^10 dose of exosomes overexpressing CD24 | Experimental | Drug: CovenD24The patients will receive the dose of 10^10 exosomes overexpressing CD24 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A COVID-19 diagnosis confirmed with a SARS-CoV-2 infection positive polymerase chain reaction (PCR) within 30 days of screening.
- 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 (6 listed)
- Any concomitant illness that, based on the judgment of the Investigator might affect the interpretation or the results of the study (i.e., immunodeficiency).
- Mechanically-ventilated patient or patient who will probably require ICU admission or mechanical ventilation within 24 hours from enrolment, according to the Investigator's judgment.
- Previous complete or partial vaccination for SARS-CoV-2.
- Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding.
- Participation in any other Interventional study in the last 30 days
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 |
|---|---|---|
| CovenD24Also: Exo-CD24The drug will be administrated once daily for 5 days | Drug | 10^10 dose of exosomes overexpressing CD24, 10^9 dose of exosomes overexpressing CD24 |
Primary outcome
Collection of serious adverse events
Time frame: Through study completion, an average of 4 months
* Incidence of treatment (dose)-related serious adverse events. * Incidence of all adverse events related or unrelated to the study treatment.
Proportion of patients related with Respiratory rate and SpO2 saturation
Time frame: Through study completion, an average of 4 months
* Proportion of patients with respiratory rate < 23/min for at least 24 hours, on Day 7. * Proportion of patients with SpO2 saturation >94%, on room air for at least 24 hours, on Day 7. * Proportion of patients with a decrease by 50% in either CRP/LDH/Fibrinogen/Ferritin/D-dimers from baseline to Day 7.
23 secondary outcomes
Improvement of COVID19 status from severe to moderate
Time frame: Through study completion, an average of 4 months
Time to recovery
Time frame: Through study completion, an average of 4 months
Death rate
Time frame: Through study completion, an average of 4 months
No need for mechanical ventilation
Time frame: Through study completion, an average of 4 months
Patients status regarding haemodynamic instability
Time frame: Through study completion, an average of 4 months
Oxygen saturation
Time frame: Through study completion, an average of 4 months
Time to death or respiratory failure
Time frame: Through study completion, an average of 4 months
Hospital discharge time
Time frame: Through study completion, an average of 4 months
No of patients that will need Intensive Care Unit
Time frame: Through study completion, an average of 4 months
No of patients with respiratory rate < 23/min
Time frame: Through study completion, an average of 4 months
No of patients with change in respiratory change
Time frame: Through study completion, an average of 4 months
No of patients with SpO2 >94%
Time frame: Through study completion, an average of 4 months
No of patients with change in oxygen saturation
Time frame: Through study completion, an average of 4 months
No of patients with change in lymphocyte count
Time frame: Through study completion, an average of 4 months
Changes in absolute lymphocyte count
Time frame: Through study completion, an average of 4 months
No of patients with changes in the neutrophil-to-lymphocyte ratio
Time frame: Through study completion, an average of 4 months
Changes in the neutrophil-to-lymphocyte ratio
Time frame: Through study completion, an average of 4 months
No of patients with changes in disease severity
Time frame: Through study completion, an average of 4 months
Time of disease improvement
Time frame: Through study completion, an average of 4 months
Changes in COVID-19 clinical severity
Time frame: Through study completion, an average of 4 months
Changes in common COVID-19 related symptoms
Time frame: Through study completion, an average of 4 months
Changes in supplemental oxygen over time
Time frame: Through study completion, an average of 4 months
Duration of oxygen administration
Time frame: Through study completion, an average of 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 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 contact
Sotirios Tsiodras, Prof principal investigator
Attikon University Hospital, Athens, Greece
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CovenD24 in people with Covid19, run by Athens Medical Society at 3 sites in Greece.
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 6 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 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. 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 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?
Contact Sotirios Tsiodras, Prof (0030-210-5831990, stsiodras.office@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of serious adverse events (time frame: Through study completion, an average of 4 months). The study lists 2 primary outcomes in all. 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 15 Jun 2021.