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| Column | Value |
|---|---|
| Trial registration number | NCT04303507 |
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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 : Jan. 20, 2022, 11:30 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 20, 2022, 11:30 a.m. Source : ClinicalTrials.gov |
William@tropmedres.ac |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-03-11 |
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Recruitment status
Last imported at : May 6, 2022, 5 a.m. Source : ClinicalTrials.gov |
Completed |
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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 |
multi-center |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
study participants the study population is adult healthcare workers and other persons defined by the site investigator at risk of contracting covid-19. inclusion criteria participant is willing and able to give informed consent for participation in the study and agrees with the study and its conduct agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals adults (exact age is dependent on countries) less than 70 years old at the time of consent not previously diagnosed with covid-19 not currently symptomatic with an ari participant is a healthcare worker or is a person at risk of contracting covid-19. possesses an internet-enabled smartphone (android or ios) |
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Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines contraindication to taking chloroquine as prophylaxis e.g. known epileptic, known creatinine clearance < 10 ml/min already taking chloroquine, hydroxychloroquine or 4-aminoquinolines, or history of these medications within the previous 7 days taking prohibited medications known retinal disease inability to be followed up for the trial period known prolonged qt syndrome (however ecg is not required at baseline) known pregnancy or women who are actively trying to become pregnant prior diagnosis of porphyria previously received any dose of covid-19 vaccine the investigator may consult the physician's guidance documents for any further questions regarding eligibility of potential participants. prohibited medications for the purpose of study enrollment include: antiarrhythmic medications: digoxin, amiodarone, sotalol, flecainide antiparasitic/malarial agents: mefloquine, halofantrine, praziquantel antibiotics: levofloxacin, moxifloxacin, ciprofloxacin, azithromycin, clarithromycin, erythromycin antifungal drugs: fluconazole, ketoconazole, itraconazole, terfenadine psychoactive drugs: lithium, quetiapine, chlorpromazine, thioridazine, ziprasidone, haloperidol, droperidol, methadone migraine treatment: sumatriptan antihistamines: astemizole antiemetics: prochlorperazine, metoclopramide cancer treatments: abiraterone, dabrafenib, dacomitinib, enzalutamide, idelalisib, mitotane other specific drugs: ciclosporin, conivaptan, agalsidase alfa or beta, mifepristone, stiripentol principai investigators will also be directed to crediblemeds.org to check other agents that may prolong qt interval |
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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 |
University of Oxford |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
16 |
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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 : Feb. 6, 2022, 2 p.m. Source : ClinicalTrials.gov |
Benin;Ivory Coast;Indonesia;Kenya;Mali;Nepal;Pakistan;Thailand;United Kingdom;Zambia |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Health workers |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : April 5, 2023, 8 p.m. Source : ClinicalTrials.gov |
4652 |
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primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Number of symptomatic COVID-19 infections |
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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 : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
Not reported |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |