This study is designed to assess the antiviral activity of hydroxychloroquine in patients with SARS-CoV-2 virus. To evaluate the antiviral effects of hydroxychloroquine at the earliest stages of disease, the study will be conducted in outpatient…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint:
- Change from baseline in nasopharyngeal SARS-CoV-2 viral load on Day 3 (if
quantitative PCR is available)
- Number of participants by PCR result status (positive or negative) (if
quantitative PCR is not available)
Secondary outcome
Secondary endpoints:
- Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load
- Number of participants by PCR result status (positive or negative)
- Number of participants with COVID-19 symptoms by severity
- Time to resolution of COVID-19 symptoms
- Time to resolution of fever
- Percentage of participants with resolution of fever
- Percentage of participants hospitalized
- Number of participants with adverse events
Background summary
Hydroxychloroquine is a drug used for malaria and also for the treatment of
certain types of rheumatism, among others rheumatoid arthritis and lupus. We do
not know exactly how the drug works, however it is believed that it partially
works by influencing the acidity in some parts of the cells in our body.
Several studies showed that this drug can decrease the inflammation by acting
on the immune system. In a recent smaller study it showed that the treatment
with hydroxychloroquine could decrease the amount of SARS-CoV-2 virus in the
nose and throat. With this study we hope to answer this question.
Study objective
This study is designed to assess the antiviral activity of hydroxychloroquine
in patients with SARS-CoV-2 virus. To evaluate the antiviral effects of
hydroxychloroquine at the earliest stages of disease, the study will be
conducted in outpatient adults immediately follow diagnosis of infection with
SARS-CoV-2 virus.
Study design
Phase 1b, randomized, double-blinded, placebo-controlled study.
Intervention
- Hydroxychloroquine 200 mg or
- Placebo
Day 1: 4 capsules hydroxychloroquine or placebo, then 2 units
hydroxychloroquine or placebo 6-8 hours later
Days 2-10: 1 capsule hydroxychloroquine or placebo 3 times daily
Study burden and risks
Burden and risks are related to the blood sampling, nasopharyngeale swab, and
possible side effects of the study medication.
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Paasheuvelweg 25
Amsterdam 1105 BP
NL
Listed location countries
Age
Inclusion criteria
- Participants * 18 years and * 80 years of age
- Participants with a diagnosis of COVID-19 via an approved or authorized
molecular test
- Presence of symptoms compatible with COVID-19 at the time of screening
- Time between onset of symptoms and first dose of hydroxychloroquine or
placebo is 96 hours or less
- Female participants must use an acceptable birth control method, as specified
by each site and country
Exclusion criteria
- COVID-19 disease requiring the use of suplemental oxygen
- Electrocardiogram (ECG) tracing with QTc interval > 450 ms for men, > 470 ms
for women (Fridericia algorithm recommended)
- Bradycardia (< 50 beats/min)
- History of cardiac disease (e.g. congestive heart failure, myocardial
infarction)
- History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
- Women who are pregnant or breastfeeding
- Concurrent antimicrobial therapy
- Hydroxychloroquine use within 2 months before enrollment
- Known hypersensitivity to hydroxychloroquine or other 4-aminoquinoline
compounds
- History of severe skin reactions such as Sevens-Johnson syndrome and toxic
epidermal
necrolysis
- History of retinopathy
- Concurrent use of antiepileptic medications
- History of arrythmia, concurrent use of anti-arrhythmic drugs, or family
history of sudden
cardiac death
- History of severe renal disease (treatment with dialysis or phosphate
binders) or hepatic
impairment
- History of organ transplant or stem cell transplant
- Body weight below 60 kg
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 2020-001269-35 |
| EudraCT | EUCTR2020-001269-35-NL |
| CCMO | NL73589.056.20 |