COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05593770

NECTAR Project Manager

nectar@rokcservices.com

2022-10-25

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: hospitalized for covid-19 ≥18 years of age sars-cov-2 infection, documented by: nucleic acid test (nat) or equivalent testing within 3 days prior to randomization or documented by nat or equivalent testing more than 3 days prior to randomization and progressive disease suggestive of ongoing sars-cov-2 infection per the responsible investigator (for non-nat tests, only those deemed with equivalent specificity to nat by the protocol team will be allowed. a central list of allowed non- nat tests is maintained in appendix e. appendix e. non-nat tests deemed with equivalent specificity to nat by the protocol team). hypoxemia, defined as spo2 <92% on room air, new receipt of supplemental oxygen to maintain spo2 ≥92%, or increased supplemental oxygen to maintain spo2 ≥92% for a patient on chronic oxygen therapy symptoms or signs of acute covid-19, defined as one or more of the following: cough reported or documented body temperature of 100.4 degrees fahrenheit or greater shortness of breath chest pain infiltrates on chest imaging (x-ray, ct scan, lung ultrasound)

onset of covid-19 symptom fulfilling inclusion criterion #5 >14 days prior to randomization hospitalized with hypoxemia (as defined in inclusion #4) for >72 hours prior to randomization (the 72-hour window for randomization begins when the patient first meets the hypoxemia inclusion criteria after hospital admission) pregnancy breastfeeding prisoners end-stage renal disease (esrd) on dialysis patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life. the treating clinician expects inability to participate in study procedures or participation would not be in the best interests of the patient known allergy/hypersensitivity to imp or its excipients fostamatinib arm-specific

2

NEAT ID Foundation

18

100

Brazil;Germany;Italy;South Africa;Spain

Moderate disease at enrollment

3: Moderate disease at enrollment

1600

Oxygen free days through day 28

None

Phase 2/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"}]