COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04329611

Christopher Inchley

chris.inchley@gmail.com

2020-04-01

Terminated

RCT

Randomized

Single group assignment

Blind label

multi-center

Treatment

inclusion criteria: confirmed sars-cov-2 infection, defined as rt-pcr provincial laboratory confirmation. self-reported symptoms of sars-cov-2 infection including any of the following: fever ≥37.5°c, cough, dyspnea, chest tightness, malaise, sore throat, myalgias, or coryza time from a positive test result to day 1 of treatment within 4 days time from patient reported first symptoms to day 1 of treatment within 12 days adults, age 18 and over, with any risk factor for severe disease resident of alberta or if not a resident of alberta able to provide complete follow-up data agrees to use adequate contraception for the duration of the study informed consent

currently or imminently planned admission to hospital any contraindication to hydroxychloroquine : known hypersensitivity to hydroxychloroquine, chloroquine, or other 4-aminoquinoline derivatives, or any component of the formulation known diagnosis of g6pd deficiency or porphyria known retinal eye disease with vision impairment, in which hydroxychloroquine is a known contraindication known history of qtc prolongation or qtc of > 470 msec (males) or > 480 msec (females) on any ecg within the previous year, if available unexplained syncope or family history of long qt syndrome or family history of premature sudden cardiac death at < 50 years of age severe diarrhea and/or vomiting or any eating disorders or any persistent vomiting condition known significant liver disease including cirrhosis associated with any history of ascites, encephalopathy, or variceal bleeding as per history or medical chart (or child pugh b&c) or alcoholic hepatitis uncontrolled epilepsy (more than 2 seizures within the previous year or any hospitalizations for status epilepticus within the previous 2 years) current use of hydroxychloroquine (plaquenil), chloroquine, lumefantrine, mefloquine, quinine, artemether, cyclosporine, dapsone, digoxin, and drugs that are known to prolong the qtc as per section 7.5.2. score of 7 or more on the tisdale scale modified such that instead of (1) admission potassium, any known serum potassium within the previous 30 days will be used; if no serum potassium is available the sub-score will be 0, and (2) admission ecg, any known ecg within the previous year will be used; if no ecg is available, the sub-score will be 0; (3) use of hcq will be included as one risk factor and anyone concurrently using a medication from the list of drugs known to prolong the qtc will already be excluded. (the other major risk factors for prolonged qtc are sepsis, heart failure, acute myocardial infarction, none of which are likely to be encountered in the outpatient setting). participation in an ongoing interventional clinical trial within the previous 30 days use of hydroxychloroquine (plaquenil) or chloroquine, lumefantrine, mefloquine, or quinine within the previous 30 days. inability to swallow pills or any other reason that compliance with the medical regimen is not likely pregnant or breastfeeding severe underlying disease where treatment is not likely to be beneficial to the patient.

2

Dr. Michael Hill

18

100

Canada

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

148

Composite of hospitalization, invasive mechanical ventilation or death within 30 days

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"}]