Status:
WITHDRAWN
Hydroxychloroquine or Diltiazem-Niclosamide for the Treatment of COVID-19
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
I-site University Lille North Europe
Conditions:
Sars-CoV2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
No optimal antiviral intervention has been yet validated to treat COVID-19 disease. Comorbidities, such as older age, obesity, diabetes, history of cardiovascular diseases are associated with poor pro...
Eligibility Criteria
Inclusion
- Positive SARS-CoV-2 test on nasopharyngeal swab
- Onset of symptoms \<8 days prior to randomization
- NEWS score\<4 AND no item ≥2
- At least one comorbidity among: age ≥ 70 years old, history of cardiac disease, diabetes, obesity, chronic kidney disease, chronic respiratory failure, immunosuppression, neoplasia, liver failure (stage ≥ Child-Pugh B)
- Fully able to understand the challenges of the trial
- Signed informed consent
- Covered by Health Insurance
Exclusion
- For all patients:
- Inability to decide to participate
- Pregnancy or breath feeding
- Hypersensitivity to any of the test drugs
- stage 4 or 5 chronic kidney disease (DFG \<30 mL/min/1.73 m²)
- For hydroxychloroquine arm:
- Long QT syndrome or QTc space \>500 ms
- Treatment with piperazine, halofantrine, dasatinib, nilotinib, citalopram, escitalopram, hydroxyzine, domperidone
- Hepatic porphyria, retinopathy, known glucose-6-phosphate dehydrogenase deficiency,
- Heart rate \<50/min
- hypokaliemia \< 3.5 mmol/L
- For diltiazem arm:
- Heart rate\<40/min
- Sinus bradycardia, second- or third-degree atrioventricular block
- Left heart insufficiency with pulmonary stasis
- Treatment with dantrolene, pimozide, dihydroergotamine, ergotamine, nifedipine, ivabradine, esmolol, bêta-blockers (bisoprolol, carvedilol, metoprolol, nebivolol), fingolimod
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04372082
Start Date
May 1 2020
End Date
May 1 2023
Last Update
March 11 2021
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