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| Column | Value |
|---|---|
| Trial registration number | NCT04969172 |
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Full text link
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
2021-07-20 |
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Recruitment status
Last imported at : July 9, 2023, 8 a.m. Source : ClinicalTrials.gov |
Unknown |
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Study design
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
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
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
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 |
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Number of arms
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Eli Sprecher, MD |
|
Inclusion age min
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
80 |
|
Countries
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Israel |
|
Type of patients
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
155 |
|
primary outcome
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
To assess the COVID-19-related symptoms using patient-reported outcome measure (PRO) score.;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 the safety of EXO-CD24 in the treatment of patients with moderate or severe COVID-19 disease;To evaluate time from hospitalization to hospital discharge.;To evaluate time to improvement and recovery (COVID-19 clinical severity score of 3 or lower). |
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Notes
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : July 21, 2021, 4 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 494, "treatment_name": "Covend24", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |