Early Intervention in COVID-19: Favipiravir Verses Standard Care (PIONEER)

This is an interventional treatment trial for Coronavirus Infection focused on measuring COVID-19, Coronavirus Read More

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