COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04382625

Sean Cook, D.O.;Jeanette Berg, MD, PhD;Sterling McPherson, PhD;John Roll, PhD

Sandra Albritton, salbritton@kh.org (PI email not reported)

2020-05-11

Withdrawn

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: age > 18 years of age sars-cov-2 positive per fda approved rt-pcr (reverse transcription-polymerase chain reaction) acute hypoxia (o2 sat < 90 % or pao2 < 60 on room air), or above baseline chronic o2 requirement inpatient admission

requires supplemental o2 >10 litres per minute or mechanical ventilation on admission pregnancy ast/alt > 5 times the upper limit normal baseline prolonged qt child-pugh score b or greater esrd(end-stage renal disease) requiring dialysis known allergy to medication component, history of severe g6pd (glucose-6-phosphate dehydrogenase) myasthenia gravis porphyria ongoing treatment for epilepsy life expectancy < 6 months, patient lacks capacity to provide consent and does not have a surrogate decision maker. retinal disease

2

Kootenai Health

18

None

United States

Severe disease at enrollment

6: Severe disease at enrollment

0

Change from Baseline Oxygenation at Day 5;Change from Baseline Oxygenation on Day 1 to Day 5

None

Phase 4

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]