healthcare worker exposure response and outcomes of hydroxychloroquine

Conditions: COVID-19

Summary: this is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to covid-19. eligible participants will be randomly assigned (1:1) to either treatment group (hcq) or placebo in a double-blind fashion. course of treatment is 30 days.

this is a double blind, placebo controlled study in approximately 2,000 health care workers at risk for being exposed to covid-19. eligible participants will be randomly assigned (1:1) to either treatment group (hcq) or placebo in a double-blind fashion. after enrollment, baseline assessments will include nasopharyngeal swab for covid-19 and a blood sample to detect seroconversion to covid-19. for convenience, follow-up will be performed weekly through a direct to participant portal. a call center will provide support for any missed visits. follow-up includes screening for any covid-19 clinical infections, other respiratory infections, clinical events, adverse events, and quality of life (qol) assessments. course of treatment is 30 days. participants are followed via survey weekly. at the end of treatment participants will return for repeat nasopharyngeal swab for covid-19 and a blood sample to detect seroconversion to covid-19. there will be one last contact at 8 weeks (2 months) from baseline.

Eligibility criteria:
inclusion: * completed informed consent * age ≥ 18 years old * currently working in any environment in which there is a risk of exposure to patients with covid-19 infections ("healthcare worker") exclusion criteria: * prior diagnosis of covid-19 infection * participation in another covid-19 prophylaxis trial within 30 days of consent * respiratory illness with new-onset fever (temperature \> 100°f) or ongoing cough or dyspnea within 14 days * known allergy to hcq or chloroquine * congenital prolonged qt syndrome * current or planned use of qt prolonging drugs (e.g. procainamide, disopyramide, mexiletine, flecainide, propafenone, amiodarone, sotalol, cimetidine, dronedarone, dofetilide, levofloxacin, ciprofloxacin, moxifloxacin) and other contraindicated medications * end stage renal disease * pre-existing retinopathy * current or planned use of hydroxychloroquine (study drug) for any indication current or planned use of the following for treatment or prevention of covid-19 infection: * chloroquine * azithromycin * known cirrhosis or severe liver disease * history of severe skin reactions such as steven-johnson syndrome, toxic epidermal necrolysis * history of psoriasis or porphyria * ventricular arrhythmias requiring medical treatment * severe coronary artery disease or heart failure/cardiomyopathy with ongoing symptoms * current or planned use of use of anti-seizure drugs * history of glucose-6-phosphate dehydrogenase deficiency

Keywords: hydroxychloroquine coronavirus infections novel coronavirus protective agents prophylaxis chemoprophylaxis severe acute respiratory syndrome respiratory distress syndrome, adult acute lung injury virus diseases lung diseases respiratory tract diseases respiration disorders lung injury coronaviridae infections nidovirales infections rna virus infections respiratory tract infections antimalarials antiprotozoal agents antiparasitic agents anti-infective agents enzyme inhibitors molecular mechanisms of pharmacological action antirheumatic agents chloroquine chloroquine diphosphate