COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT03852537

Yadav Hemang

Amy L Amsbaugh, amsbaugh.amy@mayo.edu (PI email not reported)

25/02/2020

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

for the pneumonia arm of the study: inclusion criteria: - patients admitted to hospital with community acquired pneumonia. - acute respiratory failure spo2/fio2 < 315 (spo2<90% on room air or <97% on 2l nc).

- contraindications or unwilling to use steroids by patient or provider - refractory septic shock defined as a requirement of norepinephrine dose or equivalent above >0.1 microgram/kilogram/minute or 2 or more vasopressors - pre-admission chronic use of steroids or other immunosuppressive medications - adrenal insufficiency - comfort care - leukopenia <1000/mm or neutropenia <500/mm (except if attributable to pneumonia) and hiv positive with a cd4 count <100 - recent or past history of bone marrow or solid organ transplantation - hospital admission in the previous 30 days - suspected flare of interstitial lung disease (infectious and non-infectious) - positive influenza testing or high suspicion for influenza for the covid-19 arm of the study: inclusion criteria: - patients admitted to hospital with covid-19 pneumonia (high suspicion or confirmed by positive sars cov-2 testing). - acute respiratory failure spo2/fio2 < 315 (spo2<90% on room air or <97% on 2l nc).

2

Mayo Clinic

18

100

United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

44

Timely Initiation of Corticosteroids and Implementation of Biomarker-titrated Corticosteroid Dosing

None

Phase 2

[{"arm_notes": "", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]