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Trial - NCT04902183


Column Value
Trial registration number NCT04902183
Full text link
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04902183

First author
Last imported at : June 17, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Sotirios Tsiodras, Prof

Contact
Last imported at : June 17, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

stsiodras.office@gmail.com

Registration date
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2021-05-26

Recruitment status
Last imported at : June 4, 2023, 4 a.m.
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : May 28, 2021, 12:32 a.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 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): 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 willing and able to sign an informed consent.

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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.

Number of arms
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Athens Medical Society

Inclusion age min
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : June 17, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Greece

Type of patients
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

90

primary outcome
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Collection of serious adverse events;Proportion of patients related with Respiratory rate and SpO2 saturation

Notes
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : May 28, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "10^9 exosome particules", "treatment_id": 494, "treatment_name": "Covend24", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "10^10 exosome particules", "treatment_id": 494, "treatment_name": "Covend24", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}]