Coronavirus disease 2019 (COVID-19) caused by the infection, SARS-CoV-2 MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Hydroxychloroquine
Pharmaceutical Form: Tablet
INN or Proposed INN: Hydroxychloroquine
CAS Number: 118-42-3
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration nu
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be included in the trial the participant MUST: 1) Have given written informed consent to participate 2) Be aged 18 years to 70 years 3) Not previously have been diagnosed with COVID-19 4) Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: The presence of any of the following will mean participants are ineligible: 1) Known COVID-19 positive test at baseline (if available) 2) Symptomatic for possible COVID-19 at baseline 3) Known hypersensitivity reaction to HCQ, chloroquine or 4-aminoquinolines 4) Known retinal disease 5) Known porphyria 6) Known chronic kidney disease (CKD; eGFR<30ml/min) 7) Known epilepsy 8) Known heart failure or conduction problems 9) Known significant liver disease (Gilbert’s syndrome is permitted) 10) Known glucose-6-phosphate dehydrogenase (G6PD) deficiency 11) Currently taking any of the following contraindicated medications: a. Digoxin b. Chloroquine c. Halofantrine d. Amiodarone e. Moxifloxacin f. Cyclosporin g. Mefloquine h. Praziquantel i. Ciprofloxacin j. Clarithromycin k. Prochlorperazine l. Fluconazole 12) Currently taking hydroxychloroquine or having a clinical indication for taking hydroxychloroquine 13) Currently breastfeeding 14) Unable to be followed-up during the trial 15) Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) before study follow-up visit 16) Not able to use or have access to a modern phone device/web-based technology 17) Any other clinical reason which may preclude entry in the opinion of the investigator
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): (1) Time to positive COVID-19 disease between HCQ weekly and daily arms (2) Number of COVID-19 NHS test positive cases per study arm (3) Number of COVID-19 serological test positive cases per study arm (4) Severity of COVID-19 disease between each arm – (i) not requiring hospitalisation, requiring admission, HDU/ICU admission, death; (ii) length of personal sickness, length of inpatient stay [self-isolation due to contacts with positive household members will not be included] (iii) patient reported outcome measures (5)Differences in incidence of common COVID-19 complications between arms ;Timepoint(s) of evaluation of this end point: (1) Weekly over 90 days (2) Over 90 days (3) Over 90 days (4) Over 90 days (5) Over 90 days | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principle research objective is to determine whether giving the drug Hydroxychloroquine increases time to COVID-19 disease in healthy frontline healthcare workers compared to giving a placebo.;Secondary Objective: • To determine whether giving hydroxychloroquine daily versus weekly decreases time to COVID-19 disease in healthy frontline healthcare workers • To compare the number of confirmed COVID-19 cases between each group on the basis of different testing methods • To compare disease severity in each group • To compare recovery time in each group;Primary end point(s): Time to positive COVID-19 disease ;Timepoint(s) of evaluation of this end point: Weekly over approximately 90 days | — |
Countries
United Kingdom
Outcome results
None listed