COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04372017

Susan Hoover, MD

Christie Ellison, christie.ellison@sanfordhealth.org (PI email not reported)

2020-05-01

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: inclusion criteria cohort a: - ≥ 18 years old - employee of healthcare organization in south dakota or sanford health employee in any location and with exposure to a person with covid-19 within the last 5 days - occupational exposure as determined by the participant's employee health department (i.e. not wearing the proper personal protective equipment (ppe)) - criteria according to center for disease control (cdc) guidelines - community exposure (within 6 feet for at least 15 minutes) - no current symptoms attributable to covid-19, per hcw report (fever, cough, difficulty breathing, sore throat) - no prior covid-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion) - ability to provide informed consent inclusion criteria - cohort b - ≥ 18 years old - high-risk person who had close contact (i.e. within 6 feet for at least 15 minutes) with a covid-19 positive person within the last 5 days and is a south dakota resident or high-risk person with close household contact of a covid-19 positive sanford employee - high-risk person defined by: - age 18-44 with 2 or more comorbidities listed below - age 45-79 with any comorbid condition listed below - age 80 and above (regardless of comorbid conditions) - co-morbid list - congestive heart failure (chf) - chronic lung disease (includes any of the following: asthma, chronic obstructive pulmonary disease, emphysema) - solid organ transplant or immunosuppression (defined as an outpatient prescription of greater than 10 mg/day of prednisone or equivalent, use of chemotherapy, or use of immunosuppressive agents for solid organ transplant or for an autoimmune disease.) - chronic kidney disease or end stage renal disease - diabetes mellitus - cardiovascular disease/hypertension - smoking/vaping (currently using or history of using in the past 1 year) - obesity (calculated by height and weight per participant report) - hyperlipidemia - no current symptoms attributable to covid-19 - no prior covid-19 positive diagnosis (eligible if previous testing is negative and meets all other inclusion and exclusion) - ability to provide informed consent - confirmed review of concomitant medications (with emphasis on cardiac medications) exclusion criteria cohort a & b: - known allergy to hydroxychloroquine or quinine - known history of long qt syndrome - known history of arrhythmia or dysrhythmia - known current qtc >500 ms - known g6pd deficiency - known history of hypoglycemia - pregnant or nursing by patient history - use of any of the following concomitant medications: see appendix d for exclusion medication list - concurrent diagnosis of dermatitis, porphyria, or psoriasis - history of chronic liver disease, including cirrhosis and/or diagnosis of hepatitis (infectious, idiopathic, or immune) - history of chronic kidney disease - pre-existing retinopathy - already taking hydroxychloroquine - any condition or medication in the opinion of the investigator that would prohibit the use of hydroxychloroquine - enrollment in another clinical with investigational drug or device - inability to swallow pills - adults unable to provide informed consent

None

4

Sanford Health

18

None

United States

High risk patients

N/A

1

Cohort B: Percentage of COVID-19 exposed high-risk individuals treated with hydroxychloroquine with a positive COVID-19 test.;Cohort A: Percentage of COVID-19 exposed healthcare workers treated with hydroxychloroquine with a positive COVID-19 test.

None

Phase 3

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