COVID-19: addition of azithromycin to chloroquine treatment
Phase 3
Suspended
- Conditions
- COVID-19 infection10024970
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
• Proven diagnosis of COVID-19 by positive PCR in any specimen < 48 hours
prior to randomization.
• Age >= 18 year
• Hospitalized patients with illness of any duration, and SpO2 <= 94% on room
air
Exclusion Criteria
• Severe hypoxemic respiratory failure expected to die < 72 hours after
admission
• ICU admission < 72 hours
• Allergy for chloroquine or azithromycin
• Pregnancy
• QT-prolongation: pre-existent: QTc males >450ms, QTc females > 470ms at
day 1 and at day 2
• Myasthenia gravis
• Epilepsy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The initial response to treatment will be evaluated during admission.<br /><br>Cure is considered when 4 criteria are present:<br /><br>(1) O2 sat > 94% with room air<br /><br>(2) 24 hours without fever (>=38°C)<br /><br>(3) Breathing frequency < / = 20/min<br /><br><br /><br><br /><br>The percentage of patients with clinical cure at day 7 will be calculated</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Does addition of azithromycin to standard chloroquine treatment result in a<br /><br>higher viral clearance rate at day 7 confirmed by a negative COVID-19 PCR than<br /><br>treatment with chloroquine alone in patients with COVID-19.<br /><br>• Time of clinical cure (days)<br /><br>• Length of stay<br /><br>• Number of ICU admissions<br /><br>• Mortality<br /><br>• Adverse events<br /><br><br /><br>Other study parameters (if applicable):<br /><br>- Medical history<br /><br>- Comorbidities<br /><br>- Smoking status<br /><br>- Weight</p><br>