Status:
SUSPENDED
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
Lead Sponsor:
Edesa Biotech Inc.
Collaborating Sponsors:
JSS Medical Research Inc.
Conditions:
COVID-19
ARDS
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
COVID-19 patients who develop severe disease often develop acute respiratory distress syndrome (ARDS) as a result of a dysregulated immune response. This in turn stimulates a pro-inflammatory cascade ...
Eligibility Criteria
Inclusion
- 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 two 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.
- Hospitalized and intubated with additional organ support - pressors, RRT, ECMO - Level 7 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 obtained by any patient capable of giving consent, or, when the patient is not capable of giving consent, from his or her legal/authorized representatives.
Exclusion
- The subject is a female who is breastfeeding or pregnant.
- Known hypersensitivity to EB05 or its excipients.
- 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.
- Experiencing cardiac arrest while hospitalized with COVID-19.
- Active participation in other immunomodulator or immunosuppressant drug clinical trials.
- a. Participation in COVID-19 antiviral, anticoagulant and convalescent plasma trials may be permitted; however, the decision to enroll a patient who is participating in other clinical trials will be dealt with on a case-by-case basis.
- Treatment with immunomodulator or immunosuppressant drugs, including but not limited to TNF inhibitors and anti-IL-1 agents within 5 half-lives or 30 days (whichever is longer) before randomization. Except for the following, which are permitted:
- Treatment with immunomodulator, or immunosuppressant drugs, such as corticosteroids, as part of SOC for COVID-19
- Transplant patients
- Known other clinical conditions that contraindicate EB05 and cannot be treated or solved according to the judgment of the clinician.
- Patient has been intubated or mechanically ventilated for more than 72 hours prior to administration of the investigational product.
- Patient has been intubated and then extubated during the current hospitalization prior to administration of the investigational product.
- Patient has experienced meaningful clinical improvement in the severity of disease prior to administration of the investigational product.
Key Trial Info
Start Date :
November 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
644 Patients enrolled
Trial Details
Trial ID
NCT04401475
Start Date
November 25 2020
End Date
December 1 2024
Last Update
November 14 2024
Active Locations (20)
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1
UCSF Fresno
Fresno, California, United States, 93701
2
St. Jude Medical Center/ Providence
Fullerton, California, United States, 92835
3
University of Miami Hospital
Coral Gables, Florida, United States, 33146
4
Baystate Medical Center
Springfield, Massachusetts, United States, 01199