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Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04385264 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : May 13, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : May 13, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
blaise.genton@unisante.ch |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-05-12 |
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Recruitment status
Last imported at : May 13, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Suspended |
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Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria (index cases): - age >=18 years old and - sars-cov-2 positive and - well enough to self-isolate at home (at an address in switzerland) and - at risk of complications from covid-19 i.e. one or more of the following - age >=65 years - hypertension - diabetes - cardiovascular disease (history of infarction or peripheral arteriopathy or cerebrovascular accident or cardiac insufficiency) - chronic respiratory disease - immunosuppression - cancer - obesity (bmi>40) exclusion criteria (index cases): - allergy to hydroxychloroquine/4-aminoquinilones - retinal eye disease - known chronic kidney disease, stage 4 or 5 or receiving dialysis - weight < 40 kg - known porphyria - known psoriasis - known myasthenia gravis - taking drugs with moderate-severe interactions with hcq - taking ≥ 2 qt prolonging drugs - taking 1 qt prolonging drug and a loop diuretic - moderate or severe heart failure - severe or uncontrolled arrhythmia - recent myocardial infarction or stroke (past 6 months) - current pregnancy - current hospitalisation - known hemolytic anaemia inclusion criteria (household contacts): - age >1 year old and - living in same household as index case during self-isolation exclusion criteria (household contacts): - history of laboratory-confirmed sars-cov-2 infection |
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Switzerland |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
|
Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
800 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Proportion of poor outcomes (in index cases) |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"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"}] |