Early Intervention in COVID-19: Favipiravir Verses Standard Care

• Status: Active, not recruiting
• Trial end date: 2021-06-25
• Target enrollment: 0
• Participant gender: All

Summary

Currently we do not know how best to treat patients infected with COVID-19. This study is looking at whether randomising participants to either favipiravir or to usual care, can help patients with suspected or proven COVID-19 infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chelsea and Westminster NHS Foundation Trust
• Collaborators: FUJIFILM Toyama Chemical Co., Ltd.; Imperial College London; NEAT ID Foundation; Universitaire Ziekenhuizen Leuven
• Treatments: Azithromycin; Favipiravir; Hydroxychloroquine; Zinc; Zinc Sulfate

Criteria

Inclusion Criteria:

1. Adult participants: Signed informed consent

2. New admission to hospital for period expected to last ≥ 1 night

3. Suspected or confirmed COVID-19 infection

Patients are suspected of COVID-19 infection if they have the following:

· Influenza like illness (fever ≥37.8°C and at least one of the following respiratory symptoms, which must be of acute onset: persistent cough, hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing or sneezing).

And

· Finding from either a chest x-ray or CT suggestive of Covid-19 infection

And

· Alternative causes are considered unlikely

4. For women to be eligible to enter and participate in the study they should be: of non-child-bearing

• potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,

• or of child-bearing potential have a negative pregnancy test at screening and agrees to remain sexually abstinent or use a method of contraception with a failure rate of < 1% per year as indicated in Appendix B during the treatment and for a period of 7 days after the last dose. Hormonal contraceptive methods must be supplemented by a barrier method.

5. Men who are sexually active must use an adequate method of contraception as listed in Appendix B, for a period of at least 7 days after the last dose

Exclusion Criteria:

1. Pregnant or breast feeding, due to potential teratogenicity

2. Hepatic impairment - (AST or ALT > 3.5 x upper limit of normal)

3. Presently enrolled in an interventional drug study

4. Unable to take medication via the oral or nasogastric route

5. Known sensitivity Favipiravir