An interventional study of Chloroquine or Hydroxychloroquine and Placebo in COVID19, Coronavirus and Acute Respiratory Illnesses, sponsored by University of Oxford. Completed at 25 sites in 10 countries. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by University of Oxford · Not applicable, Interventional, and Prevention
The study is a double-blind, randomised, placebo-controlled trial that will be conducted primarily in healthcare settings and other facilities directly involved in COVID-19 case management. We will recruit healthcare workers and other persons at risk of contracting COVID-19, who can be followed reliably for 5 months. The initial aim was to recruit 40,000 participants and we predict an average of 400-800 participants per site in 50-100 sites.
The participant will be randomised to receive either chloroquine or placebo (1:1 randomisation), or to hydroxychloroquine or placebo (1:1 randomisation). A loading dose of 10mg base/kg (four 155mg tablets for a 60kg subject), followed by 155 mg daily (250mg chloroquine phosphate salt/ 200mg hydroxychloroquine sulphate) will be taken for 3 months.
If the participant is diagnosed with COVID-19, they will take continue to take the study medication until:
Episodes of symptomatic respiratory illness, including symptomatic COVID-19, and clinical outcomes will be recorded in the Case Record Form during the follow-up period.
This study is funded by Wellcome Trust Grant reference 221307/Z/20/Z.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 4,652 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Oxford is the lead sponsor of 812 studies on the registry; 119 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Study Participants The study population is adult healthcare workers and other persons defined by the site investigator at risk of contracting COVID-19.
Inclusion Criteria
Exclusion Criteria:
The investigator may consult the physician's guidance documents for any further questions regarding eligibility of potential participants.
Prohibited medications for the purpose of study enrollment include:
PrincipaI Investigators will also be directed to crediblemeds.org to check other agents that may prolong QT interval
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In Asia, the participant will receive chloroquine. In Europe, the participant will receive hydroxychloroquine Specific drug allocation will be determined by country prior to activation based upon factors such as inventory availability and importation requirements
Drug: Chloroquine or Hydroxychloroquine
Drug: Placebo
Drug pages: Chloroquine · Hydroxychloroquine
A loading dose of 10 mg base/ kg followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg of or hydroxychloroquine sulphate) will be taken for 3 months
Placebo
Number of symptomatic COVID-19 infections
Number of symptomatic COVID-19 infections will be compared between the chloroquine or hydroxychloroquine and placebo groups
Time frame: Approximately 90 days
Symptoms severity of COVID-19
Symptoms severity of COVID-19 will be compared between the two groups using a respiratory severity score.
Time frame: Approximately 90 days
Number of asymptomatic cases of COVID-19
Number of asymptomatic cases of COVID-19 will be determined by comparing serology in all participants at time of enrolment and at the end of follow up.
Time frame: Approximately 90 days
Number of symptomatic acute respiratory illnesses
Number of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Time frame: Approximately 90 days
Severity of symptomatic acute respiratory illnesses
Severity of symptomatic acute respiratory illnesses will be compared between the chloroquine or hydroxychloroquine and placebo groups.
Time frame: Approximately 90 days
Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, ARI and disease severity.
Genetic loci and levels of biochemical components will be correlated with frequency of COVID-19, Acute Respiratory Infection and disease severity.
Time frame: Approximately 90 days
Assess the impact of chloroquine or hydroxychloroquine prophylaxis on number of days lost to work during the pandemic.
Number of days lost to work in relation to the treatment arm
Time frame: Approximately 90 days
Assess the impact of chloroquine or hydroxychloroquine prophylaxis on healthcare costs
The trial will collect data on monetary costs associated with the use of healthcare resources and determine the effects between treatment groups.
Time frame: Approximately 90 days
Assess the impact of chloroquine or hydroxychloroquine prophylaxis on quality of life measures using the quality of life questionnaire (EQ-5D-3L)
The trial will collect data on health-related quality of life using the quality of life questionnaire (EQ-5D-3L) to determine the effects between treatment groups.
Time frame: Approximately 90 days
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — With participant's consent, suitably anonymised clinical data and results from blood analyses stored in the database may be shared according to the terms defined in the MORU data sharing policy with other researchers to use in the future.
Data sharing details ↗ · www.tropmedres.ac
Ran from Apr 2020 to primary completion in Mar 2022, 22 months.
Of 1,338 non-industry interventional studies with no phase under COVID-19, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 20. This study's 22 months is above that.
Counting every sponsor, half of 1,476 studies reached it within 9 months; a quarter within 3 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Chloroquine · Hydroxychloroquine