COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04363827

Giovanni Martinelli, Prof.

giovanni.martinelli@irst.emr.it

2020-04-27

Unknown

RCT

Randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: male or female, aged >= 18 years sars-cov-2-exposed subjects, as household members and/or contacts of covid-19 patients (group 1). in this group are included health care professionals in contact with covid-19 patients. or covid-19 patients, asymptomatic or paucisymptomatic in home situation who are not in treatment with any anti covid-19 medication (group 2) absence of any covid-19 symptom in last week before randomization (fever >37.5°c, cough, dyspnea) (only for group 1 subjects) paracetamol treatment is accepted only for group 2. participant is willing and able to give informed consent for participation in the study (either recorded during a telephonic interview or signed in person) and agrees with the study and its conduct.

reported anamnesis for: intolerance or previous toxicity for hydroxychloroquine/chloroquine bradycardia or reduction rhythm of heart with arrythmias ischemic heart disease retinopathy congestive heart failure under/with use of diuretics favism or glucose-6-phosphate dehydrogenase (g6pd) deficiency diabetes type 1 major comorbidities like advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmias, any oncologic/hematologic malignancy. severe neurological and mental illness any other contraindication to take hydroxychloroquine already taking chloroquine, hydroxychloroquine or analogous during the past 3 weeks use of other antiviral agents in the last 3 weeks subject with a positive test for sars-cov-2 (for group 1) pregnant or lactating current use of medications with known significant drug-drug interactions: digoxin, hypoglycemic agents, anticonvulsant, cyclosporine, phenylbutazone, drugs that inhibit cyp2d6 known prolonged qt syndrome or current use of drugs with known qt prolongation participation in another clinical trial with any investigational agents within 30 days prior to study screening.

4

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

18

None

Italy

Close contacts to covid patients

N/A

2300

the proportion of subjects of Group 1 who become symptomatic and/or swab positive in each arm within 1 month from randomization.;the proportion of subjects of Group 2 who become swab negative in each arm within 14 days from randomization.

None

Phase 2

[{"arm_notes": "A loading dose Hydroxychloroquine 400 mg twice daily at day 1, followed by a weekly dose of Hydroxychloroquine 200 mg twice daily on days 8, 15 and 22, covering a total of 1 month of treatment.", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "A loading dose Hydroxychloroquine 400 mg twice daily at day 1 followed by 200 mg twice daily for a total of at least 5-7 days according to clinical evolution.", "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"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]