COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04323631

Paul Rambam MC

M_paul@rambam.health.gov.il

2020-03-26

Withdrawn

RCT

Randomized

Sequential assignment

Open label

multi-center

Treatment

inclusion criteria: - adult patients (>18 years) - confirmed covid-19 infection by real-time pcr from a respiratory or other body sample within 48 hours of testing. - mild to moderate infection or asymptomatic patients with comorbidities: symptomatic patients with fever >37.9ºc or cough or dyspnea or chest pain, not fulfilling severity exclusion criteria. we will include patients regardless of time since symptom onset. in addition, we will include asymptomatic patients with comorbidities including cardiac, pulmonary, diabetes, chronic renal failure or liver disease hospitalized for observation. - informed consent from patient or legal representative.

- severe infection, defined as need for invasive or non-invasive ventilator support, ecmo or shock requiring vasopressor support. - unable to take oral medication - known allergy to hcq or chloroquine - prolonged qt, defined as qtc ≥450 milliseconds for men and as qtc ≥470 for women - severely reduced lv function (ejection fraction<30%) - retinopathy - pregnancy or breast feeding - concomitant treatment with azithromycin, flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, pimozide. - chronic chloroquine/ hcq treatment (within 1 month) - need for hemodialysis - participating in another rct for treatment of covid-19

2

Rambam Health Care Campus

18

None

None

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

0

Number patients developing severe infection or death

None

Phase 1

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]