Favipiravir vs Hydroxychloroquine vs Control in COVID -19
Status:
Completed
Trial end date:
2021-04-07
Target enrollment:
Participant gender:
Summary
Hydroxychloroquine is widely used to treat autoimmune diseases. Clinical investigation has
found that a high concentration of cytokines were detected in the plasma of critically ill
patients infected with SARS-CoV-2, therefore, hydroxychloroquine as anti-inflammatory agents
may reduce this response in accord with their use in autoimmune disease where the cytokine
response can be reduced.
Favipiravir is an antiviral drug developed in Japan that the data sheet notes that it is a
pyrazinecarboxamide derivative with activity against influenza viruses, west nile virus,
yellow fever virus, foot and mouth disease virus as well as against flaviviruses,
arenaviruses, bunyaviruses and alphaviruses. In February the drug was used for COVID-19
disease in China and was declared effective in treatment, and a report published (in press)
comparing Favipiravir with Lopinavir /ritonavir suggested that Favipiravir was superior for
prevention of disease progression and viral clearance.
The objective of this pilot study is to compare three arms: hydroxychloroquine; favipiravir;
standard care (no specific SARS-CoV-2 treatment) only, in symptomatic patients infected by
SARS-CoV-2 in an open label randomized clinical trial. The difference between groups will
allow an effect size to be determined for a definitive clinical trial.
Phase:
Phase 2
Details
Lead Sponsor:
Royal College of Surgeons in Ireland - Medical University of Bahrain
Collaborators:
Bahrain Defence Force Royal Medical Services, Military Hospital Ebrahim Khalil Kanoo Community Medical Center Hereditary blood Disorder Centre - Salmaniya Medical Complex Jidhafs COVID-19 Centre Mohammed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre, Awali Salmaniya Medical Complex- 6th Floor Salmaniya Medical Complex- Helipad Sitra FICU