COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-002184-22/GR

Athens Medical Society - Matina Katsaouni

iea@mednet.gr

2021-05-05

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. A COVID-19 diagnosis confirmed with a SARS-CoV-2 infection positive polymerase chain reaction (PCR) test within 30 days from 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.

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

2

Athens Medical Society

18

80

Greece

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

90

Primary Safety Endpoints: • Incidence of treatment (dose)-related serious adverse events. • Incidence of all adverse events related or unrelated to the study treatment. Primary Efficacy Endpoints: • 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.

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

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