An open label randomized controlled trial of chloroquine, hydroxychloroquine or only supportive care in patients admitted with moderate to severe COVID-19

Completed

• Conditions: dyspnoea; Hypoxemia; 10047438

• Registration Number: NL-OMON49317
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-06-09
• Results First Posted: 2020-06-10
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

Patients (>=18 years of age) admitted to the hospital with confirmed COVID-19
and not needing admission to MC or ICU
Patient has moderate to severe COVID-19. This will be defined as patients with
NEWS-2 score <= 5

Exclusion Criteria

- Severe Covid-19 defined as NEWS-2 score >5 or admission to the ICU needing
ventilation or pressure support.
- Contra-indications for hydroxychloroquine or chloroquine
- Known pregnancy, not using adequate contraception and having a chance of
being pregnant (unless a negative pregnancy test is documented).
- Unable to take oral medication (chloroquine and hydroxychloroquine can be
administered through tube feeding which is considered oral administration)
- Identified allergies to 4-aminoquinoline
- Severe diseases of the blood system
- 6-phosphate dehydrogenase deficiency
- History of acute myocardial infarction, unstable angina pectoris, severe
arrhythmia (frequent ventricular, ventricular tachycardia, ventricular
fibrillation) in recent 6 months; New York Heart Association (NYHA) level III-IV
- Corrected QT interval (QTc) >= 500ms on baseline electrocardiogram.
- Uncorrected severe hypokalaemia (< 2,5 mmol/l) or uncorrected severe
hypomagnesemia (< 0.6 mmol/l)
- Pancreatitis
- Refusal to participate expressed by patient or legally authorized
representative if they are present

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Disease progression defined as a NEWS-2 score >= 7 within 14 days, or admission<br /><br>to Medium Care or Intensive Care Unit, or death</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Assessing the proportion of side effects of different drugs leading to<br /><br>regimen change or discontinuation of the anti-COVID-19antiviral treatment</p><br>