Overview

Hydroxychloroquine or Diltiazem-Niclosamide for the Treatment of COVID-19

Status:
Withdrawn
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
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 prognosis. This study aims to evaluate the efficacy of two experimental antiviral treatments, compared to standard of care (SOC), to prevent clinical worsening, hospitalization or death at day 14 in adults with documented SARS-CoV-2 infection, asymptomatic or with symptoms lasting less than 8 days, and associated comorbidities without any severity criteria of the disease at inclusion. Participants will be randomized to receive SOC alone or SOC + hydroxychloroquine 200 mg three times a day during 10 days or SOC + association of niclosamide 2 g at J1 then 500 mg two times a day with diltiazem 60 mg three times a day during 10 days. Efficacy and tolerance of each treatments will be compared across the three treatment groups during the 28 days of follow-up.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital, Lille
Collaborator:
I-site University Lille North Europe
Treatments:
Diltiazem
Hydroxychloroquine
Niclosamide