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

Chelsea and Westminster NHS Foundation Trust

Status and phase: Completed; Phase 3

Conditions: Coronavirus Infection

Treatments: Drug: Favipiravir; Other: Standard of care management

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04373733

2020-001449-38 (EudraCT Number)

CW002

Details and patient eligibility

About

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.

Full description

A prospective, randomised, open label study of the combined use of favipiravir and standard clinical care verses standard clinical care alone.

A computer-based software will randomise participants 1:1 to either receive favipiravir and standard medical care or standard medical care alone. The allocated medical regime will commence for 10 days.

Research blood, sputum nose swab and urine samples will be collected at baseline, as well as between day 5 and 10, and between day 14 and 28 to enable comparative analyses.

A COVID-19 antibody test will also be performed 14-28 days after randomisation. In the event of clinically indicated bronchoscopy taking place within 28 days of consent then additional bronchoscopy washing and brushing samples and paired blood sample will be taken for research purposes If a participant is discharged before one of the latter time points, they will be required to return to hospital (provided they are well enough) for the collection of repeat samples.

Participants will be closely monitored whilst taking the study medications. Participants will study exit at subject death or 28 days post-randomisation.

Enrollment: 502 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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502 participants in 2 patient groups

Favipiravir & Standard of Care

Experimental group

Description:

Favipiravir: Day 1 1800mg twice per day, Days 2-10 800mg twice per day

Treatment:

Other: Standard of care management

Drug: Favipiravir

Standard of care

Other group

Description:

No trial intervention

Treatment:

Other: Standard of care management