Profliaxis of SARS-CoV-2 infection MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Idrossiclorochina
Product Code: [n.d.]
Pharmaceutical Form: Tablet
CAS Number: 118-42-3
Current Sponsor code: n.d.
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
UNIVERSITY OF OXFORD
Eligibility
Sex/Gender
All
Inclusion criteria
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) • Not previously diagnosed with COVID-19 • Not currently symptomatic with an ARI • Participant A. works in healthcare facility or other well characterised high-risk environment, OR B. is an inpatient or relative of a patient in a participating hospital and likely exposed to COVID-19 infection or another high-risk group • Possesses an internet-enabled smartphone (Android or iOS) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 37500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2500
Exclusion criteria
Exclusion criteria: • 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 • Taking a concomitant medication described in section 8.5, which cannot be safely stopped • Known retinal disease • Inability to be followed up for the trial period • Known prolonged QT syndrome (however ECG is not required at baseline)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if chloroquine or hydroxychloroquine prophylaxis prevents symptomatic COVID-19 infection in health care workers or other groups at high risk. To determine if chloroquine or hydroxychloroquine prophylaxis attenuates COVID-19 infections.;Secondary Objective: To determine if chloroquine or hydroxychloroquine prophylaxis prevents asymptomatic COVID-19 infection. To determine if chloroquine or hydroxychloroquine prophylaxis prevents all-cause symptomatic acute respiratory illnesses. To characterise genetic and baseline biochemical markers associated with symptomatic COVID-19, respiratory illness and disease severity.;Primary end point(s): The number of symptomatic COVID-19 infections will be compared between the chloroquine and placebo groups. The symptoms severity and duration of COVID-19 illness, in those who become infected during the study will be compared between the two groups using a respiratory severity score.;Timepoint(s) of evaluation of this end point: During the clinical trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The number of asymptomatic cases of COVID-19 will be determined by comparing acute and convalescent serology in the two groups.; The number and severity of symptomatic acute respiratory illnesses will be compared in subjects randomised to chloroquine or placebo.; Genetic loci and levels of biochemical components will be correlated with occurrence of and disease severity of COVID-19 or other ARIs.;Timepoint(s) of evaluation of this end point: During clinical trial; During clinical trial; During clinical trial | — |
Countries
Indonesia, Italy, Kenya, Lao People's Democratic Republic, Malawi, Thailand, Uganda, United Kingdom, Vietnam
Contacts
Public ContactUnità per la Ricerca Clinica
IRCCS Sacro Cuore Don Calabria
Outcome results
None listed