ISRCTN10207947已完成未知
Chloroquine/ hydroxychloroquine prevention of coronavirus disease (COVID-19) in the healthcare setting; a randomised, placebo-controlled prophylaxis study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 4,646
研究概览
简要总结
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39264960/ (added 16/09/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 03/06/2021:
- •1. Participant is willing and able to give informed consent for participation in the study and agrees with the study and its conduct
- •2. Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals
- •3. Adults (exact age is dependent on countries) less than 70 years old at the time of consent
- •4. Not previously diagnosed with COVID-19
- •5. Not currently symptomatic with an ARI
- •6. Participant is a healthcare worker or is a person at risk of contracting COVID-19.
- •7. Possesses an internet-enabled smartphone (Android or iOS)
- •Previous participant inclusion criteria:
- •1. Willing and able to give informed consent for participation in the study and agrees with the study and its conduct
- •2. Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals
- •3. Adults (exact age is dependent on countries) <70 years old at the time of consent
- •4. Not previously diagnosed with COVID-19
- •5. Not currently symptomatic with an ARI
- •6. Working in a facility where there are cases of either proven or suspected COVID-19
- •7. Possesses an internet-enabled smartphone (Android or iOS)
排除标准
- •Current participant exclusion criteria as of 03/06/2021:
- •1. Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines
- •2. Contraindication to taking chloroquine as prophylaxis e.g. known epileptic, known creatinine clearance <10 ml/min
- •3. Already taking chloroquine, hydroxychloroquine or 4-aminoquinolines, or history of these medications within the previous 7 days
- •4. Taking any of the following prohibited medications:
- •4.1. Antiarrhythmic medications: digoxin, amiodarone, sotalol, flecainide
- •4.2. Antiparasitic/malarial agents: mefloquine, halofantrine, praziquantel
- •4.3. Antibiotics: levofloxacin, moxifloxacin, ciprofloxacin, azithromycin, clarithromycin, erythromycin
- •4.4. Antifungal drugs: fluconazole, ketoconazole, itraconazole, terfenadine
- •4.5. Psychoactive drugs: lithium, quetiapine, chlorpromazine, thioridazine, ziprasidone, haloperidol, droperidol, methadone
- •4.6. Migraine treatment: sumatriptan
- •4.7. Antihistamines: astemizole
- •4.8. Antiemetics: prochlorperazine, metoclopramide
- •4.9. Cancer treatments: abiraterone, dabrafenib, dacomitinib, enzalutamide, idelalisib, mitotane
- •4.10. Other specific drugs: ciclosporin, conivaptan, agalsidase alfa or beta, mifepristone, stiripentol
- •5. Known retinal disease
- •6. Inability to be followed up for the trial period
- •7. Known prolonged QT syndrome (however ECG is not required at baseline)
- •8. Known pregnancy or women who are actively trying to become pregnant
- •9. Prior diagnosis of porphyria
- •10. Previously received any dose of COVID-19 vaccine
- •11. The investigator may consult the physician’s guidance documents for any further questions regarding the eligibility of potential participants.
- •Previous participant exclusion criteria:
- •1. Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines
- •2. Contraindication to taking chloroquine as prophylaxis e.g. known epileptic, known creatinine clearance <10 ml/min
- •3. Already taking chloroquine, hydroxychloroquine or 4-aminoquinolines
- •4. Taking a concomitant medication
- •5. Known retinal disease
- •6. Inability to be followed up for the trial period
- •7. Known prolonged QT syndrome (however ECG is not required at baseline)
- •8. Known pregnancy or women who are actively trying to become pregnant
- •9. Prior diagnosis of porphyria
研究者
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