COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04342169

Adam Spivak, MD

Christina Pacchia, christina.pacchia@hsc.utah.edu (PI email not reported)

2020-04-10

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: - patient age ≥18 years, competent to provide consent - within 48 hours of positive nucleic acid test for sars-cov-2

- patient already prescribed chloroquine or hydroxychloroquine - allergy to hydroxychloroquine - history of bone marrow or solid organ transplant - known g6pd deficiency - chronic hemodialysis, peritoneal dialysis, continuous renal replacement therapy or glomerular filtration rate < 20ml/min/1.73m2 - known liver disease (e.g. child pugh score ≥ b or ast>2 times upper limit) - psoriasis - porphyria - known cardiac conduction delay (qtc > 500msec) or taking any prescription medications known to prolong qt interval - concomitant use of digitalis, flecainide, amiodarone, procainamide, or propafenone - seizure disorder - prisoner - weight < 35kg - inability to follow-up - no cell phone or no address or not spanish or english speaking - receipt of any experimental treatment for sars-cov-2 (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation - patient or another member of patient's household has been already enrolled in this study.

2

University of Utah

18

None

United States

Mild disease at enrollment

1: Mild disease at enrollment

368

Duration of viral shedding

None

Phase 2

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]