COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04629703

Not reported

Not reported

2020-11-16

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - ≥18 years of age at screening. - the subject or a legally authorized representative has provided written informed consent. - hospitalized covid-19 subjects without respiratory failure who are either not receiving any oxygen therapy or are receiving supplemental oxygen via mask or nasal prongs. - male or non-pregnant, non-lactating female subjects with sars-cov-2 infection documented by a hospital approved diagnostic test (eg, a food and drug administration authorized test in the us) within 7 days prior to randomization.

- pregnant or lactating female of childbearing potential. - use of extracorporeal membrane oxygenation (ecmo). - uncontrolled hypertension (systolic blood pressure [bp] ≥160 mmhg and/or diastolic bp ≥100 mmhg), unstable angina, congestive heart failure of new york heart association classification iii or iv, serious cardiac arrhythmia requiring treatment at screening. - history of myocardial infarction within 1 month prior to screening.

2

Rigel Pharmaceuticals

18

100

Argentina;Brazil;Mexico;United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

280

Number of days on oxygen from randomization on Day 1 to Day 29

None

Phase 3

[{"arm_notes": "", "treatment_id": 525, "treatment_name": "Fostamatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]