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

Suspended

• Conditions: COVID-19

• Registration Number: NL-OMON24112
• Lead Sponsor: MC Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 950

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.
-Willing and able to give written informed consent

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) or breast-feeding
-Unable to take oral medication (chloroquine and hydroxychloroquine can be administered through tube feeding and 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) = 480ms on baseline electrocardiogram. (The treatment guideline states: An electrocardiogram is made before start chloroquine and hydroxychloroquine)
-Uncorrected severe hypokalaemia (< 2,5 mmol/l) or uncorrected severe hypomagnesemia (< 0.6 mmol/l)
-Pancreatitis
-Concomitant medication that affect drug absorption, metabolism and excretion, that can induce QT interval prolongation:
oAmiodarone, disopyramide, flecainide, ibutailide, kinidine, sotalol,
ochlorpromazine, citolapram, escitalopram, haloperidol, pimozide,
oazitromycine, claritromycine, erytromycine, moxifloxacine, trimethoprim/sulfamethoxazole,
oDimperidon, ondansetron,
oMethadon,
oAnagrelide, arseentrioxide, droperidol, pentamidine, sevofluraan, vandetanib.
-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
-Composite endpoint with disease progression defined as a NEWS2score = 7 within 14 days or resulting in admission to Intensive/Medium Care unit or resulting in death within 14 days.

Secondary Outcome Measures

Name	Time	Method
-Side effects of different drugs leading to regimen change or discontinuation of the antiviral treatment