Status:
TERMINATED
Chloroquine, Hydroxychloroquine or Only Supportive Care in Patients AdmItted With Moderate to Severe COVID-19
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
COVID-19
Eligibility:
All Genders
18-110 years
Phase:
PHASE4
Brief Summary
Rationale: Currently there are no approved treatments for COVID-19. In the Dutch treatment protocol guideline (SWAB) designated treatment is supportive care with the option to add chloroquine base (CQ...
Detailed Description
Study rationale CQ and HCQ were both employed in the treatment of COVID-19 in China. Based on unpublished anecdotal positive results in China, CQ is now implemented in China and the Netherlands in sev...
Eligibility Criteria
Inclusion
- \- 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.
- Willing and able to give written informed consent
Exclusion
- \- 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
- 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
- Known corrected QT interval (QTc) ≥ 500ms.
- 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
Key Trial Info
Start Date :
April 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04362332
Start Date
April 14 2020
End Date
June 8 2020
Last Update
June 19 2020
Active Locations (1)
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1
UMCU
Utrecht, Netherlands, 3508GA