Favipiravir vs Hydroxychloroquine vs Control in COVID -19

• Status: Completed
• Trial end date: 2021-04-07
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

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
• Treatments: Favipiravir; Hydroxychloroquine

Criteria

Inclusion Criteria:

• Admitted COVID-19 patients being treated as an in-patient at a hospital facility.

• COVID-19 diagnosis confirmed by PCR nasopharyngeal swab.

• Study participants must be symptomatic with any COVID-19 symptoms defined by the Bahrain National Protocol

• Onset of symptoms must be within 10 days prior to enrolment.

• Study participants must have the ability to give informed consent.

• Participants must be at minimum 21 years of age.

• Mild to Moderate COVID-19 disease defined as saturation equals to or more than 93% on room air or PaO2:FiO2 ratio more than 300 on enrolment.

Exclusion Criteria:

• Severe COVID-19 disease: defined as presence of SpO₂ less than 93% on room air or a PaO₂ to FiO₂ ratio of 300 or lower.

• Patients on ventilatory support.

• Cardiac dysfunction that would preclude treatment with hydroxychloroquine:

1. Patients on medication known to prolong QT segment.

2. Known history of LQT syndrome.

3. Acquired QT prolongation at baseline >500ms.

4. AV block.

5. Bundle Branch Block.

6. Known history of Cardiomyopathy, Pulmonary Hypertension, or Sick Sinus Syndrome.

7. History of ventricular tachyarrhythmia.

8. Patients with implantable cardioverter-defibrillator (ICD).

9. Patients with a baseline bradycardia of less than 50 beats per minute.

• Renal dysfunction (estimated glomerular filtration rate less than 30ml/min).

• Hepatic dysfunction defined as:

1. Transaminitis more than three times the upper limit of normal or

2. Chronic liver disease of Child Pugh Class B or higher.

• Gout or a history of gout

• Patients that are pregnant or breastfeeding.

• Patients with a known allergy to an intervention medication.

• Patients who receive any of the study medications prior to randomization

• Patient with G6PD

• Readmission due to COVID19 disease.

• Participants in any other COVID-19 disease trial.

• Patients on immunosuppressants, HIV patients, cancer patients who received chemotherapy within the past 6 months, or who are on chronic oral steroids.

• Patients unable to give informed consent.