COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04526912

Gábor Illei, MD, PhD, MHS

IlleiG@VielaBio.com

2020-08-26

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

key inclusion criteria: - hospitalized with coronavirus disease 2019 (covid-19) pneumonia confirmed by world health organization criteria. - oxygen saturation ≤ 94% at room air or arterial partial pressure of oxygen/fraction of inspired oxygen < 300 mm hg and > 200 mm hg. - negative influenza test. - lymphocyte counts < 10^3/μl and the presence of at least one of the following markers of hyperinflammation within 1 day prior to vib7734 administration: - elevated high sensitivity c-reactive protein (hscrp) > 50 mg/l - ferritin > 500 ng/ml - lactate dehydrogenase (ldh) > 300 u/l - d-dimers > 500 ng/ml note: other protocol defined inclusion criteria apply key

- respiratory failure requiring mechanical ventilation. - in the opinion of the investigator, progression to mechanical ventilation or death is imminent and inevitable within the next 24 hours. - valid do not intubate (dni) or do not resuscitate (dnr) order. - anticipated duration of hospital stay < 72 hours. - history of allergy or hypersensitivity reaction to any component of the ip. - participation in another clinical study with an ip within 4 weeks prior to day 1 or within 5 half-lives of the ip, whichever is longer. (participation in covid-19 antiviral or antimalarial trials may be permitted after discussion with the medical monitor). - liver cirrhosis or liver failure. - known human immunodeficiency virus infection. - known hepatitis b or known hepatitis c infection in the absence of a history of curative therapy. - known or suspect active or latent tuberculosis infection. - active bacterial, fungal, viral, or other infection (besides covid-19). - clinically significant cardiac disease within 6 months. - history of severely impaired respiratory function at baseline (not related to covid-19) based on requirement for home oxygen of > 4 l/min or based on other medical history known to the investigator. - history of cancer within 12 months of enrollment. - receipt of chemotherapy, biologic immunomodulators (including jak inhibitors), or immunosuppressive therapies within 8 weeks of enrollment, or receipt of rituximab or other b cell-depleting mab therapy within 6 months. note: other protocol defined exclusion criteria apply

2

Viela Bio

18

80

United States

Severe disease at enrollment

6: Severe disease at enrollment

10

The proportion of patients who achieve treatment success through Day 28, defined as avoidance of death and critical illness

None

Phase 1

[{"arm_notes": "", "treatment_id": 1358, "treatment_name": "Vib7734", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]