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Trial record 2 of 3 for:    EXO-CD24

Safety and Efficacy of Exosomes Overexpressing CD24 in Two Doses for Patients With Moderate or Severe COVID-19

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ClinicalTrials.gov Identifier: NCT04902183
Recruitment Status : Recruiting
First Posted : May 26, 2021
Last Update Posted : June 15, 2021
Sponsor:
Collaborators:
OBCTCD24 Ltd
Elpen Pharmaceutical Co. Inc.
Information provided by (Responsible Party):
Athens Medical Society

Brief 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 infection.

Condition or disease Intervention/treatment Phase
Covid19 Drug: CovenD24 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Masking Description: The administrated dose will be unknown to the patients
Primary Purpose: Treatment
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
Actual Study Start Date : June 9, 2021
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Arm Intervention/treatment
Experimental: 10^9 dose of exosomes overexpressing CD24
The patients will receive the dose of 10^9 exosomes overexpressing CD24
Drug: CovenD24
The drug will be administrated once daily for 5 days
Other Name: Exo-CD24

Experimental: 10^10 dose of exosomes overexpressing CD24
The patients will receive the dose of 10^10 exosomes overexpressing CD24
Drug: CovenD24
The drug will be administrated once daily for 5 days
Other Name: Exo-CD24




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Improvement of COVID19 status from severe to moderate [ Time Frame: Through study completion, an average of 4 months ]
    • 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"

  2. Time to recovery [ Time Frame: Through study completion, an average of 4 months ]
    • Time to recovery, measured from enrolment (Day 1) to recovery or last follow-up (Day 28).

  3. Death rate [ Time Frame: Through study completion, an average of 4 months ]
    • Death rate at end of study (Day 28)

  4. No need for mechanical ventilation [ Time Frame: Through study completion, an average of 4 months ]
    • Proportion of patients with no mechanical ventilation (ECMO, NIV, high flow) on Day 7.

  5. Patients status regarding haemodynamic instability [ Time Frame: Through study completion, an average of 4 months ]
    • Proportion of patients with haemodynamic instability or requiring vasopressors on Day 7.

  6. Oxygen saturation [ Time Frame: Through study completion, an average of 4 months ]
    • Change in the SpO2/FiO2 ratio on Day 7.

  7. Time to death or respiratory failure [ Time Frame: Through study completion, an average of 4 months ]
    • 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).

  8. Hospital discharge time [ Time Frame: Through study completion, an average of 4 months ]
    • 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.

  9. No of patients that will need Intensive Care Unit [ Time Frame: Through study completion, an average of 4 months ]
    • Proportion of patients requiring admission to an Intensive-Care Unit (ICU) on Day 7.

  10. No of patients with respiratory rate < 23/min [ Time Frame: Through study completion, an average of 4 months ]
    • Proportion of patients with respiratory rate < 23/min for 24 hours at every visit until Day 28, inclusive.

  11. No of patients with change in respiratory change [ Time Frame: Through study completion, an average of 4 months ]
    • Proportion of patients with change [decrease/no change (±2 breaths/min)/improvement] in respiratory rate from baseline to Day 7.

  12. No of patients with SpO2 >94% [ Time Frame: Through study completion, an average of 4 months ]
    • Proportion of patients with SpO2 >94% on room air, for at least 24 hours at every visit until Day 28, inclusive.

  13. No of patients with change in oxygen saturation [ Time Frame: Through study completion, an average of 4 months ]
    • Proportion of patients with change [decrease/no change (±2 %)/improvement] in SpO2 saturation from baseline to Day 7.

  14. No of patients with change in lymphocyte count [ Time Frame: Through study completion, an average of 4 months ]
    • Proportion of patients with an increase of 25% in the absolute lymphocyte count, sustained for ≥24 hours on Day 7.

  15. Changes in absolute lymphocyte count [ Time Frame: Through study completion, an average of 4 months ]
    • Change in absolute lymphocyte count from baseline to Day 7.

  16. No of patients with changes in the neutrophil-to-lymphocyte ratio [ Time Frame: Through study completion, an average of 4 months ]
    • Proportion of patients with a decrease of 20% in the neutrophil-to-lymphocyte ratio (NLR), sustained for ≥24 hours on Day 7.

  17. Changes in the neutrophil-to-lymphocyte ratio [ Time Frame: Through study completion, an average of 4 months ]
    • Change in NLR from baseline to Day 7.

  18. No of patients with changes in disease severity [ Time Frame: Through study completion, an average of 4 months ]
    • Percentage of patients within each severity rating on the ordinal scale within 28 days of the study period (Day 1 to Day 28).

  19. Time of disease improvement [ Time Frame: Through study completion, an average of 4 months ]
    • Time to improvement in the categorical and ordinal scale, measured from randomization (Day 1) to last study follow-up (Day 28).

  20. Changes in COVID-19 clinical severity [ Time Frame: Through study completion, an average of 4 months ]
    • Change in the COVID-19 clinical severity from baseline [before-treatment assessment (Screening/Day 1)] up to Day 28.

  21. Changes in common COVID-19 related symptoms [ Time Frame: Through study completion, an average of 4 months ]
    • Change from baseline of 14 Common COVID-19-Related Symptoms, as assessed through an Investigator interview.

  22. Changes in supplemental oxygen over time [ Time Frame: Through study completion, an average of 4 months ]
    • Change in the flow rate of supplemental oxygen administration over time.

  23. Duration of oxygen administration [ Time Frame: Through study completion, an average of 4 months ]
    • The duration of supplemental (non-invasive) oxygen administration.



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 infection positive polymerase chain reaction (PCR) within 30 days of screening.
  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 >25% within 24-48 hours or a severe deterioration compared to imaging at admission.

    b. 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

  4. Willing and able to sign an informed consent.

Exclusion Criteria:

  1. Any concomitant illness that, based on the judgment of the Investigator might affect the interpretation or the results of the study (i.e., immunodeficiency).
  2. 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.
  3. Previous complete or partial vaccination for SARS-CoV-2.
  4. Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding.
  5. Participation in any other Interventional study in the last 30 days
  6. Active cancer.

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): NCT04902183


Contacts
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Contact: Sotirios Tsiodras, Prof 0030-210-5831990 stsiodras.office@gmail.com
Contact: Nadir Arber, Prof nadira@tlvmc.gov.il

Locations
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Greece
3rd Department of Medicine, "Sotiria" Thoracic Diseases General Hospital of Athens Not yet recruiting
Athens, Attica, Greece, 11527
Contact: Garyfallia Poulakou, Ass. Prof    0030-210-7763439      
Attikon University Hospital Recruiting
Athens, Attica, Greece, 12462
Contact: Sotirios Tsiodras, Prof    210-5831990    stsiodras.office@gmail.com   
7th Respiratory Medicine Department, "Sotiria" Thoracic Diseases General Hospital of Athens Not yet recruiting
Athens, Attika, Greece, 11527
Contact: Mina Gaga, Director    0030-210-7781720    7th_klin@otenet.gr   
Sponsors and Collaborators
Athens Medical Society
OBCTCD24 Ltd
Elpen Pharmaceutical Co. Inc.
Investigators
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Principal Investigator: Sotirios Tsiodras, Prof Attikon University Hospital, Athens, Greece
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Responsible Party: Athens Medical Society
ClinicalTrials.gov Identifier: NCT04902183    
Other Study ID Numbers: NS3
First Posted: May 26, 2021    Key Record Dates
Last Update Posted: June 15, 2021
Last Verified: June 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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases