COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04351243

Arnaud Bastien

arnaud.bastien@roivant.com

2020-04-17

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: male or non-pregnant female age ≥18 years, inclusive subject (or legally authorized representative) is able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form has laboratory-confirmed sars-cov-2 infection as determined by pcr or other approved clinical testing prior to randomization radiographic evidence of bilateral infiltrates subject requires high-flow oxygen or meets clinical classification for ards elevated serum crp or ferritin subjects who have been treated with convalescent plasma (cp) prior to enrollment are eligible if the subject continues to meet all inclusion criteria at screening the use of investigational anti-viral treatment (e.g., remdesivir) is allowed if the subject continues to meet all inclusion criteria at screening additional inclusion criteria are detailed in the protocol

evidence of life-threatening dysrhythmia or cardiac arrest on presentation intubated >72 hours absolute neutrophil count < 1,000 per mm3 platelet count < 50,000 per mm3 ast or alt > 5x upper limit of normal egfr <30 ml/min/1.73m2 or requiring hemofiltration or dialysis history of known anti-gm-csf autoantibodies or pulmonary alveolar proteinosis severe chronic respiratory disease (e.g., copd, pah, ipf, ild) requiring supplemental oxygen therapy or mechanical ventilation pre-hospitalization (e.g., prior to covid-19 diagnosis) use of any immunomodulatory biologic, cell therapy, or small molecule jak inhibitor within past 7 days or 5 half lives or planned use of any of these agents unless approved by medical monitor chronic (>4 weeks) use of corticosteroids >10mg/day of prednisone or equivalent known or suspected active and untreated tb, hiv, hepatitis b or c infection additional exclusion criteria are detailed in the protocol.

2

Kinevant Sciences GmbH

18

79

United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

227

Incidence of mortality

None

Phase 2

[{"arm_notes": "", "treatment_id": 542, "treatment_name": "Gimsilumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]