COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04352946

Bradley A Connor, MD

bconnor1@gmail.com

2020-04-20

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: health care worker (hcw) at the hospital who work on a "full time" basis during the study period. for the purposes of the study, "health care workers" are physicians, nurses, nurse practitioners, physician assistants, respiratory therapists, x-ray technicians, social workers and support staff (including but not limited to house-keeping, and porters). age ≥18 years. ability to communicate with study staff in english

known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds. current use of hydroxychloroquine for the treatment of a medical condition. known prolonged qt syndrome, or concomitant medications which simultaneously may prolong the qtc that cannot be temporarily suspended/replaced. these are including but not limited to class ia, ic and iii antiarrhythmics; certain antidepressants, antipsychotics, and anti-infectives; domperidone; 5-hydroxytryptamine (5-ht)3 receptor antagonists; kinase inhibitors; histone deacetylase inhibitors beta-2 adrenoceptor agonists. known pre-existing retinopathy of the eye. disclosure of self-administered use of hydroxychloroquine or chloroquine currently under investigation <4 weeks prior to study. this window is intended to account for the drug half-life of hcq (21 days). baseline symptom of covid-19 disease at enrollment and baseline viral detection specimen positive for sars-cov-2. all participants with covid-19 symptoms at enrollment will be directed to have confirmatory testing (within the department or occupational health as per the site guidelines). participants who are negative for sars-cov-2 will be redirected to enrollment procedures, those testing positive will be excluded.

2

GeoSentinel Foundation

18

None

United States

Health workers

N/A

374

Cumulative Incidence of COVID-19 Infection

None

Phase 3

[{"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"}]