COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04579393

Jeffrey R Strich

prpl@cc.nih.gov

2020-10-08

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: patient must be hospitalized, or had their inpatient stay extended, for covid-19. age >=18 years subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. subject (or legally authorized representative) understands and agrees to comply with planned study procedures. females of childbearing potential must agree to be abstinent or use a medical acceptable form of contraception from the time of enrollment through 30 days after last day of study drug laboratory confirmed sars-cov-2 rt-pcr test within 7 days of enrollment illness of any duration with spo2 of less than 94% on room air requiring supplemental oxygen via nasal canula or non-invasive mechanical ventilation, or mechanical ventilation or ecmo (5 to 7 on the 8-point scale)

alt or ast > 5 times the upper limit of normal (uln) or alt or ast >= 3 x uln and total bilirubin > 2 x uln. estimated glomerular filtration rate (egfr) <30ml/min pregnancy or breast feeding anticipated discharge in the next 72 hours allergy to study medication uncontrolled hypertension (systolic blood pressure >160mmhg or diastolic blood pressure >100mmhg) shock or hypotension at the time of enrollment neutrophil count <1000/microliter concern for bacterial or fungal sepsis received immunomodulatory treatment within 30 days prior to enrollment e.g., bruton's tyrosine kinase/phosphoinositide 3 kinase/janus kinase inhibitor or cytokine-targeting biologic therapy (anti-tnf, il-6) received a live vaccine the last 4 weeks those who were cognitively impaired or mentally disabled prior to covid diagnosis participation in another clinical trial for the treatment of covid-19.

2

National Heart, Lung, and Blood Institute (NHLBI)

18

100

United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

59

Number of Participants With at Least 1 Serious Adverse Event

None

Phase 2

[{"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"}]