A phase 1b, randomized, double-blinded, placebo-controlled study of hydroxychloroquine in outpatient adults with COVID-19

Completed

Conditions: Corona
COVID-19
10047438

Registration Number: NL-OMON49040

Lead Sponsor: Sanofi-aventis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>- Change from baseline in nasopharyngeal SARS-CoV-2 viral load on Day 3 (if<br /><br>quantitative PCR is available)<br /><br>- Number of participants by PCR result status (positive or negative) (if<br /><br>quantitative PCR is not available)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>- Change from baseline to Day 5 in nasopharyngeal SARS-CoV-2 viral load<br /><br>- Number of participants by PCR result status (positive or negative)<br /><br>- Number of participants with COVID-19 symptoms by severity<br /><br>- Time to resolution of COVID-19 symptoms<br /><br>- Time to resolution of fever<br /><br>- Percentage of participants with resolution of fever<br /><br>- Percentage of participants hospitalized<br /><br>- Number of participants with adverse events</p><br>