COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-006044-14/PL

JSS Medical Research Europe Sp. z o.o. - JSS Medical Research Europe Sp. z o

jakub.srednicki@jssresearch.com

2021-03-26

Terminated

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Main Study: All the following criteria need to be met for inclusion: 1. Men and women ≥18 years of age at the time of consent. 2. Laboratory-confirmed diagnosis of COVID-19. 3. Hospitalized for COVID-19 related respiratory disease. 4. Patient belongs to one of the following four categories in the nine-point COVID-19 severity scale: Hospitalized, requiring intubation and mechanical ventilation- Level 6 of the nine-point COVID-19 severity scale. (Cohort 1) Hospitalized, and intubated with additional organ support – pressors, RRT, ECMO – Level 7 of the nine-point COVID-19 severity scale. (Cohort 2) 5. For women of childbearing potential: negative pregnancy test and agreement to remain abstinent or to use highly effective contraceptive methods during the study, and for 11 weeks after the study drug administration (five half-lives). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. These include: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation - oral - intravaginal - transdermal Progestogen-only hormonal contraception associated with inhibition of ovulation - oral - injectable - implantable Intrauterine device (IUD) Intrauterine hormone-releasing system (IUS) Bilateral tubal occlusion Vasectomised partner 1 Sexual abstinence 2 Note: A woman of non-childbearing potential is defined as follows: Age ≥60 years of age Has had surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), Has had a cessation of menses for at least 12 months without an alternative medical cause, and a follicle-stimulating hormone (FSH) test confirming nonchildbearing potential (refer to laboratory reference ranges for confirmatory levels). 6. For men with female partners of childbearing potential: agreement to remain abstinent or use adequate contraceptive methods by yourself or your partner, as applicable, during study duration, and for 11 weeks after the study drug administration (five half-lives). These include: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation - oral - intravaginal - transdermal Progestogen-only hormonal contraception associated with inhibition of ovulation - oral - injectable - implantable Intrauterine device (IUD) Intrauterine hormone-releasing system (IUS) Bilateral tubal occlusion Vasectomised partner Sexual abstinence progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action male or female condom with or without spermicide cap, diaphragm or sponge with spermicide 7. Informed consent obtained from any patient capable of giving consent, or, when the patient is not capable of giving consent, from his or her legal/authorized representatives.

Patients will be excluded if any of the following criteria are met: 1. The subject is a female who is breastfeeding or pregnant. 2. Known hypersensitivity to EB05 or its excipients. 3. In the opinion of the investigator, death is imminent and inevitable or patient will be discharged within the next 48 - 72 hours, irrespective of the provision of treatment. 4. Experiencing cardiac arrest while hospitalized with COVID-19. 5. Active participation in other immunomodulator or immunosuppressant drug clinical trials. 6. Treatment with immunomodulator or immunosuppressant drugs, including but not limited to TNF inhibitors and antiIL-1 agents, within 5 half-lives or 30 days (whichever is longer) before randomization. (Note treatment with immunomodulator or immunosuppressant drugs, such as corticosteroids, as part of SOC, is permitted). 7. Known other clinical conditions that contraindicate EB05 and cannot be treated or solved according to the judgement of the clinician. 8. Patients that are discharged alive or die within the first 3 days after randomization.

2

Edesa Biotech Research Inc.

18

100

Canada;Colombia;Poland;United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

80

Primary Efficacy Endpoint There are two independent primary efficacy endpoints that will depend on the patient cohort. Cohort 1: WHO COVID – SEVERITY SCALE LEVEL 6: Invasive Mechanical Ventilation Ventilator-Free Days (VFD), defined as being alive and free from mechanical ventilation at Day 28 from IP administration. Cohort 2: WHO COVID – SEVERITY SCALE LEVEL 7: Critically- Ill The mortality rate at Day 28 from IP administration.

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

Phase 3

[{"arm_notes": "", "treatment_id": 2179, "treatment_name": "Eb 05", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]