Status:
UNKNOWN
PROLIFIC ChemoprophylaxisTrial (COVID-19)
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
COVID-19
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The number of confirmed cases of COVID-19 infectious disease arising from the SARS-CoV-2 coronavirus is rising substantially and rapidly, with the potential to overwhelm the ability of the entire Nati...
Detailed Description
The number of confirmed cases of COVID-19 infectious disease arising from the SARS-CoV-2 coronavirus is rising substantially and rapidly, with the potential to overwhelm the ability of the entire Nati...
Eligibility Criteria
Inclusion
- To be included in the trial the participant MUST:
- Have given written informed consent to participate
- Be aged 18 years to 70 years
- Not previously have been diagnosed with COVID-19
- Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care
Exclusion
- The presence of any of the following will mean participants are ineligible:
- Known COVID-19 positive test at baseline (if available)
- Symptomatic for possible COVID-19 at baseline
- Known hypersensitivity reaction to HCQ, chloroquine or 4-aminoquinolines
- Known retinal disease
- Known porphyria
- Known chronic kidney disease (CKD; eGFR\<30ml/min)
- Known epilepsy
- Known heart failure or conduction problems
- Known significant liver disease (Gilbert's syndrome is permitted)
- Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Currently taking any of the following contraindicated medications:
- Digoxin
- Chloroquine
- Halofantrine
- Amiodarone
- Moxifloxacin
- Cyclosporin
- Mefloquine
- Praziquantel
- Ciprofloxacin
- Clarithromycin
- Prochlorperazine
- Fluconazole
- Currently taking hydroxychloroquine or having a clinical indication for taking hydroxychloroquine
- Currently breastfeeding
- Unable to be followed-up during the trial
- Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) before study follow-up visit
- Not able to use or have access to a modern phone device/web-based technology
- Any other clinical reason which may preclude entry in the opinion of the investigator
Key Trial Info
Start Date :
May 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04352933
Start Date
May 11 2020
End Date
April 1 2021
Last Update
May 13 2020
Active Locations (1)
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1
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ