COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-004259-17/GR

OBCTCd-24 Ltd - CEO

ofer@covend24.com

2022-01-28

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. A COVID-19 diagnosis confirmed with a SARS-CoV-2 viral infection positive polymerase chain reaction (PCR) test within 15 days from screening 2. Age ≥18 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 score > 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, HIV etc.). 2. Patients with PO2< 60 at room air 3. Patients with PO2/FiO2<150 4. Patients with mechanical ventilation (ECMO), or NIV, or high flow nasal cannula) or using vasopressors or patients who will probably require ICU admission, mechanical ventilation, or the use of vasopressors within 24 hours from enrolment, according to the Investigator’s judgment 5. Pregnancy [positive urine pregnancy test (women of childbearing potential only)] or breastfeeding 6. Patient on long-term immunosuppression therapy, i.e., patient in active long-term inmmunosuppresion like rituximab 7. Participation in any other Interventional study in the last 30 days or within 5 half-lives of receiving an investigational agent.

2

OBCTCD-24 Ltd

18

100

Israel

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

135

Primary Safety Endpoint: • Incidence of all adverse events by severity, related or unrelated to the study drug. Primary Efficacy Endpoint: • Rate of improvement of COVID-19 status on Day 7 (2 days post last therapy), transitioning from “Severe” to at least “Moderate” or from “Moderate” to “Moderate-Mild” using the 10-point COVID-19 clinical severity ordinal scale

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"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"}]