COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04341116

Claire Xu

not reported

2020-04-10

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - age: 18 years or older (including 18 years); male or female - laboratory-confirmed sars-cov-2 or covid-19 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay. - bilateral lung infection confirmed by imaging. - severe disease that meets one of the following conditions: (i) at rest, finger blood oxygen saturation ≤ 93% or pao2/fio2 ≤ 300 mmhg; (ii) requiring non-invasive or invasive mechanical ventilation; or (iii) requiring high flow oxygen ≥ 15l/min - hospitalized for no more than 5 calendar days at the time of screening

- any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment. - chronic obstructive pulmonary disease (copd) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (part 1 only). - pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis. - cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); new york heart association classification (nyha): class iii-class iv. - blood system disorders or routine blood analysis test abnormalities: hemoglobin < 8 g/dl; absolute neutrophil count (anc) <1500 × 109/l; platelets < 50 × 109/l. - dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs. - subjects that have been on invasive mechanical ventilation for ≥120 hours at the time of dosing - subjects that require ecmo. - pregnant or breastfeeding females.

4

I-Mab Biopharma US Limited

18

None

United States

Severe disease at enrollment

6: Severe disease at enrollment

149

Percentage of Subjects Alive and Free of Mechanical Ventilation Among Subjects Who Are Free of Mechanical Ventilation at Baseline

None

Phase 2/Phase 3

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