Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19

Summary

This is an open-label, multicenter, parallel-group, randomized, phase III trial that evaluates the efficacy and safety of hydroxychloroquine and favipiravir in the treatment of patients with possible or confirmed COVID-19 observed within the last 5 days. 1000 patients will be randomized in 2:1:2:2:2:1 ratio and divided into six groups.

Conditions

• Sars-CoV2
• COVID-19

Interventions

DRUG

Favipiravir (3200 mg + 1200 mg)

Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator.

DRUG

Favipiravir (3600 mg + 1600 mg)

Drug: Favipiravir (3600 mg + 1600 mg) Dosage and method of administration: in a regimen of 2x1800 mg (oral) loading dose on day-1 followed by 1600 mg maintenance dose (2x800 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator.

DRUG

Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine

Hydroxychloroquine Dosage and method of administration: in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total). Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator.

DRUG

Favipiravir (3200 mg + 1200 mg) combined with Azithromycin

Azithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total). Favipiravir Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator.

DRUG

Hydroxychloroquine

Dosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (200 mg oral 2 times daily) on day-2 to day-5 (5 days in total). Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (200 mg oral 2 times daily) throughout 5 days (5 days in total).

DRUG

Hydroxychloroquine combined with Azithromycin

Drug: Hydroxychloroquine combined with Azithromycin Hydroxychloroquine Dosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total). Hydroxychloroquine Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (2x200 mg oral, 2 times daily) throughout 5 days (5 days in total). Azithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total).

Sponsors & Collaborators

• Hacettepe University, Faculty of Medicine

  collaborator UNKNOWN

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  collaborator OTHER

• Umraniye Education and Research Hospital

  collaborator OTHER_GOV

• SB Istanbul Education and Research Hospital

  collaborator OTHER

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

  collaborator OTHER

• Tepecik Training and Research Hospital

  collaborator OTHER

• Istanbul University - Cerrahpasa

  collaborator OTHER

• Ankara University

  collaborator OTHER

• Ankara City Hospital Bilkent

  collaborator OTHER

• Ankara Training and Research Hospital

  collaborator OTHER

• Ege University Hospital (Application and Research Center)

  collaborator UNKNOWN

• Kocaeli Derince Education and Research Hospital

  collaborator OTHER

• Istanbul University

  collaborator OTHER

• Kayseri City Hospital

  collaborator OTHER_GOV

• Ministry of Health, Turkey

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-05-08

Primary Completion

2020-12-31

Completion

2021-06-01

Countries

• Turkey (Türkiye)

Study Locations