Last updated 3 years ago

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of EB05 + SOC vs. Placebo + SOC in Adult Hospitalized Patients With COVID-19

396 patients around the world

Available in United States, Colombia

Edesa Biotech Inc.

396Patients around the world

Requirements for the patient

From 18 Years

All Gender

: Men and women ≥18 years of age at the time of consent.
Laboratory-confirmed diagnosis of COVID-19.
Hospitalized for COVID-19 related respiratory disease.
Patient belongs to one of the following four categories in the nine-point COVID-19 severity scale:
1. Hospitalized, not requiring supplemental oxygen - Level 3 of the nine-point COVID-19 severity scale.
2. Hospitalized, requiring supplemental oxygen - Level 4 of the nine-point COVID-19 severity scale.
3. Hospitalized, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both - Level 5 of the nine-point COVID-19 severity scale.
4. Hospitalized, requiring intubation and mechanical ventilation- Level 6 of the nine-point COVID-19 severity scale.
For women of childbearing potential involved in any sexual intercourse that could lead to pregnancy: Negative pregnancy test and willingness to use contraceptive (consistent with local regulations) during the study period.
Signed informed consent form by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives.

: The subject is a female who is breastfeeding or pregnant.
Known hypersensitivity to EB05 or its excipients.
Mechanical ventilation (including venovenous ECMO) for ≥5 days (120 hours), or any duration of venoarterial ECMO.
In the opinion of the investigator, death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment.
Active participation in other drug clinical trials.
Treatment with immunomodulator or immunosuppressant drugs, including but not limited to IL-6 inhibitors, TNF inhibitors, anti-IL-1 agents, and JAK inhibitors 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).
Known other clinical conditions that contraindicate EB05 and cannot be treated or solved according to the judgment of the clinician.
Possibility of the subject being transferred to a non-study hospital within 72h.

SponsorEdesa Biotech Inc.

Study typeInterventional

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT04401475