COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04359901

Westyn Branch-Elliman, MD

Westyn.Branch-Elliman@va.gov

2020-04-24

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

study subjects will be inpatients with confirmed sars-cov-2 testing. testing is performed at the discretion of the treating physician. only veterans will be enrolled. inclusion criteria: positive testing for novel coronavirus sars-cov-2019 patients with moderate covid-19 disease as defined clinically: score of 1-3 (out of 3) on a modified brescia covid respiratory severity score (bcrss), elements of which include wheezing or inability to speak complete sentences without effort, respiratory rate ≥22, o2 saturation ≤ 94% with or without supplemental oxygen, or requiring ≥2l supplemental oxygen to maintain o2 sat >94% in patients without previously documented hypoxia or baseline oxygenation requirement; either is equal to one point on the score) all within a 24-hour period prior to enrollment, and/or any worsening of chest x-ray (cxr) findings after covid-19 diagnosis worsening of baseline oxygenation by at least 3%, or increase in oxygen requirement by at least 2l, in patients with pre-existing hypoxemia or receiving supplemental oxygen chronically. the bcrss risk calculation score is available at: https://www.mdcalc.com/brescia-covid-respiratory-severity-scale-bcrss-algorithm

critical disease, defined by need for mechanical ventilation expected death within 48 hours patients taking any of the following for chronic inflammatory diseases: glucocorticoids equivalent to prednisone > 10 mg/day (methylprednisolone > 8 mg/day, dexamethasone > 2 mg/day), a jak inhibitor (tofacitinib, baricitinib, upadacitinib), or a biologic use of chronic inhaled steroids is not an exclusion current or recent short-term use of glucocorticoids for chronic conditions such as copd or gout is not an exclusion. current use of glucocorticoids for covid-19 is not an exclusion use of biologics for non-inflammatory diseases is not an exclusion receipt of any il-6 inhibitor within 3 months prior to enrollment in the trial pregnancy, due to lack of fetal monitoring capabilities patients enrolled in other interventional clinical trials, including for covid-19. patients enrolled in non-interventional studies or receiving non-fda-approved drugs for compassionate use are not excluded. patients whose goal of care is comfort measures only inability to provide informed consent, or absence of a legally authorized representative to provide informed consent. severe psychiatric disease that prevents compliance with typical medical care. initial positive test for active infection with novel coronavirus sars-cov-2019 was >4 weeks prior to current admission.

2

Westyn Branch-Elliman

18

None

United States

Moderate disease at enrollment

3: Moderate disease at enrollment

50

Number of Participants With Intubation or Death

None

Phase 2

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