Favipiravir vs Hydroxychloroquine vs Control in COVID -19

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.

Conditions

• SARS-CoV 2
• COVID-19

Interventions

DRUG

Hydroxychloroquine

400mg BID PO day 1 then 200mg BID PO from day 2 to day 10. In addition to Hydroxychloroquine all patients will receive the standard care (according to local Bahrain COVID19 guidelines). Any patient who is fit for discharge, can be discharged and medications will be stopped on discharge.

DRUG

Favipiravir

1600mg BID PO day 1600mg BID PO day 2 to day 10. In addition to Favipiravir all patients will receive the standard care (according to local Bahrain COVID19 guidelines). Any patient who is fit for discharge, can be discharged and medications will be stopped on discharge.

OTHER

Routine care for COVID-19 patients

Supportive care according to local guidelines

Sponsors & Collaborators

• Ebrahim Khalil Kanoo Community Medical Center

  collaborator UNKNOWN

• Hereditary blood Disorder Centre - Salmaniya Medical Complex

  collaborator UNKNOWN

• Mohammed Bin Khalifa Bin Sulman Al Khalifa Cardiac Centre, Awali

  collaborator UNKNOWN

• Jidhafs COVID-19 Centre

  collaborator UNKNOWN

• Sitra FICU

  collaborator UNKNOWN

• Salmaniya Medical Complex- 6th Floor

  collaborator UNKNOWN

• Salmaniya Medical Complex- Helipad

  collaborator UNKNOWN

• Royal College of Surgeons in Ireland - Medical University of Bahrain

  lead OTHER

Principal Investigators

• Manaf Al Qahtani, Dr. · Royal College of Surgeons in Ireland - Bahrain

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-11

Primary Completion

2021-03-06

Completion

2021-04-07

Countries

• Bahrain

Study Locations