COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04492891

Bryan Burt

Not reported

2020-07-30

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: 3.1.1 laboratory-confirmed sars-cov-2 infection within the past 10 days. 3.1.2 patients admitted to non-icu hospital floors or in an emergency department awaiting admission to a non-icu hospital bed. 3.1.3 who covid scale score 4 (oxygen by mask or nasal prongs or who covid scale score 5 (non-invasive ventilation or high-flow oxygen). 3.1.4 age 18 to 90 years old. 3.1.5 ecog (eastern cooperative oncology group) performance status ≤2 (see appendix a). 3.1.6 patients receiving or who have received standard of care therapy for covid-19 can be included. this includes remdesivir, dexamethasone (or other steroids), and convalescent plasma. 3.1.7 ability to understand and the willingness to sign a written informed consent document.

3.2.1 allergy and/or hypersensitivity to csa. 3.2.2 gfr<30 ml/min. 3.2.3 alt (alanine transaminase) or ast (aspartate transaminase) >3x upper limits of normal. 3.2.4 resistant hypertension (bp>140/90 mm hg despite adherence to maximal doses of three antihypertensive agents). 3.2.5 active bacterial or mycobacterial infection. 3.2.6 pregnant and/or nursing patients. 3.2.7 participation in a covid-19 therapeutic drug trial. 3.2.8 patients who have received or who are receiving anti-viral medications including hydroxychloroquine will not be excluded. 3.2.9 patients with psychiatric illness/social situations that would limit compliance with study requirements. 3.2.10 total cholesterol is < 100 (increased risk of seizure) 3.2.11 concomitant dosing with tacrolimus is a relative contraindication (increases overall immunosuppression and decrease seizure threshold 3.2.12 concomitant malignancy is a relative contraindication (neoral can increase susceptibility to development of neoplasia) 3.2.13 inability to swallow oral medication 3.2.14 treatment with immunomodulators or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors. 3.2.15 investigational antiviral agents

2

Bryan Burt, MD

18

90

United States

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

47

WHO(World Health Organization) COVID-19 Clinical Severity Scale

None

Phase 2

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