COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04388709

Thomas Marron, MD

Lynn Bui, lynn.bui@mssm.edu (PI email not reported)

2020-05-14

Withdrawn

RCT

Randomized

Parallel

Open label

unclear

Treatment

inclusion criteria: - confirmed diagnosis of sars-cov-2 - hospitalization due to diagnosis with sars-cov-2 - sp02 < 93% on ambient air or pao2/fio2 < 300 mmhg and requires supplemental oxygen

- patients must not be pregnant or nursing - patients cannot be admitted to intensive care unit at time of admission or require positive pressure ventilation - patients cannot be requiring continuous supplemental oxygen normally (pre-sars-cov-2) - patient is receiving steroids >1mg/kg - has diagnosis of primary immunodeficiency - has active autoimmune disease that has required systemic treatment in the past year - has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial - patients with ferritin >2000ng/ml and/or c-reactive protein >100mg/l - history of allogeneic hematopoietic cell transplantation or solid organ transplantation - childs-pugh class b or c cirrhosis or class a if portal hypertension is present - documented allergic or hypersensitivity response to protein therapeutics - no serious disease requiring mechanical ventilation at time of enrollment

2

Icahn School of Medicine at Mount Sinai

18

None

None

Severe disease at enrollment

6: Severe disease at enrollment

0

Number of participants with resolution of hypoxia

None

Phase 2

[{"arm_notes": "they call it Peginterferon lambda alfa-1a but I think it's the same", "treatment_id": 675, "treatment_name": "Interferon lambda alpha 1a", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]