Preventative Drug Treatment for COVID-19 Infectious Disease
- Conditions
- MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]Coronavirus disease 2019 (COVID-19) caused by the infection, SARS-CoV-2
- Registration Number
- EUCTR2020-001331-26-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 1000
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>•To compare the number of confirmed COVID-19 cases between each group on the basis of different testing methods<br>•To compare disease severity in each group<br>•To compare recovery time in each group;Primary end point(s): Time to positive COVID-19 disease <br>;Timepoint(s) of evaluation of this end point: Weekly over approximately 90 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): (1) Time to positive COVID-19 disease between HCQ weekly and daily arms <br>(2) Number of COVID-19 NHS test positive cases per study arm<br>(3) Number of COVID-19 serological test positive cases per study arm<br>(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<br>(5)Differences in incidence of common COVID-19 complications between arms ;Timepoint(s) of evaluation of this end point: (1) Weekly over 90 days<br>(2) Over 90 days<br>(3) Over 90 days<br>(4) Over 90 days<br>(5) Over 90 days