COVID-19
Conditions
Interventions
All treatment arms contain standard supportive care during hospital and:
1. Chloroquine arm: loading dose 600mg as chloroquine base followed by 300mg 12 hours later followed by 300mg twice a day
total treatment duration 5 days (same dose as LCI guideline)
2. Hydroxychloroquine arm: loading dose 400mg bid followed by 200mg twice a day
total treatment duration 5 days (same dose as LCI guideline)
3. No antiviral treatment arm
Sponsors
UMC Utrecht
Eligibility
Inclusion criteria
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
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: o Amiodarone, disopyramide, flecainide, ibutailide, kinidine, sotalol, o chlorpromazine, citolapram, escitalopram, haloperidol, pimozide, o azitromycine, claritromycine, erytromycine, moxifloxacine, trimethoprim/sulfamethoxazole, o Dimperidon, ondansetron, o Methadon, o Anagrelide, arseentrioxide, droperidol, pentamidine, sevofluraan, vandetanib. - Refusal to participate expressed by patient or legally authorized representative if they are present
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -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
| Measure | Time frame |
|---|---|
| - Side effects of different drugs leading to regimen change or discontinuation of the antiviral treatment | — |
Contacts
Public ContactJesper Weehuizen
UMC Utrecht
Outcome results
None listed