Official Title
Favipiravir for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
Brief Summary

Double-blinded, placebo control, randomized, phase-3 clinical trial to evaluate clinical efficacy of Favipiravir in patients with mild to moderate symptoms related to COVID-19 infection

Detailed Description

COVID-19 starts as a pure viral infection and evolves into a multifactorial disease with
components of hyper immune activation, end organ damage, and fibrosis. Suppression of viral
replication is expected to be impactful early in the course of disease. The ability to
mitigate the symptoms at an early stage will prevent progression to severe COVID-19 and can
save many lives. Early treatment could also reduce viral shedding, diminishing the period of
infectivity and decreasing the number of secondary cases.

Completed
COVID19

Drug: Favipiravir

Favipiravir

Drug: Placebo

Placebo

Eligibility Criteria

Inclusion Criteria:

- Adults age 18 or older

- Tested positive for SARS-CoV-2 by RT-PCR assay using a respiratory tract sample
(either nasopharyngeal swab OR oropharyngeal swab OR nasal aspirate OR
tracheobronchial aspirate OR saliva) collected within 72 hours of randomization

- Stated willingness to give their written informed consent to participate in the study

- Stated willingness to comply with all study procedures and availability for the
duration of the study

- Males must be sterile, OR agree not to donate semen AND agree to strictly adhere to
contraceptive measures during the study and for 7 days following the last dose of
study medication

- Females must be unable to bear children, OR ensure that their male partner is
incapable of fathering a child, OR, if of childbearing potential will strictly adhere
to contraceptive measures during the study and for seven days following the last dose
of study medication

- Females must agree to stop breast-feeding prior to first dose of study drug and
through seven days after completing therapy

- Females must have a negative pregnancy test at screening

- Ability to take oral medication and be willing to adhere to the favipiravir/placebo
regimen

- Subject has access to a smart phone, tablet, or PC

- Minimal baseline severity score for COVID-19-related symptoms: at least two symptoms
with a score of 2 or higher. COVID-19-related symptoms (excluding changes in the sense
of taste or smell) include:

- stuffy or runny nose

- sore throat

- shortness of breath

- cough

- lack of energy or tiredness

- muscle or body aches

- headache

- chills or shivering

- feeling hot or feverish

- nausea

- diarrhea

- vomiting

Exclusion Criteria:

- O2 saturation <94%

- Shortness of breath at rest

- Heart rate ≥ 125 per minute

- COVID-19 symptoms first presented >5 days prior to randomization

- Requirement for hospitalization at the time of enrollment

- Participation in another trial or use of any experimental treatment for COVID-19

- Treatment with high steroid dose i.e. >30 mg/day prednisolone equivalent (excluding
stable chronic treatment) or remdesivir or anyone receiving SARS-CoV-2 monoclonal
antibodies within 3 months prior to enrollment

- Known sepsis or organ dysfunction/ failure

- Known infection with a respiratory virus other than SARS-CoV2 (e.g. Influenza) or any
known bacterial infection (affecting the respiratory system or any other system)

- Inability to adhere to study requirements

- For premenopausal women: unwilling or unable to use effective birth control measures

- Known allergy to favipiravir

- Known end-stage kidney disease or requiring hemodialysis or continuous ambulatory
peritoneal dialysis (CAPD)

- Known liver impairment greater than Child-Pugh A

- Psychiatric illness that is not well controlled (defined as stable on a regimen for
more than one year).

- Known elevated uric acid levels in the past year or taking uric acid lowering
medications (allopurinol, febuxostat)

- History of hereditary xanthinuria or history of xanthine urolithiasis.

- History of gout or actively being treated for gout.

- Current use of the following medications, which cannot be discontinued for the
duration of the study: pyrazinamide, hydralazine, more than 3000 mg of acetaminophen
per day.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Brazil
Mexico
United States
Locations

Cahaba Research, Inc.
Pelham, Alabama, United States

Absolute Clinical Research
Phoenix, Arizona, United States

B.G Clinical Research Center, LLC
Little Rock, Arkansas, United States

Xera Med Research
Boca Raton, Florida, United States

Synergy Healthcare
Bradenton, Florida, United States

Best Quality Research,Inc.
Hialeah, Florida, United States

Elixia Clinical Research Collaborative
Hollywood, Florida, United States

Homestead Associates In Research
Miami, Florida, United States

Verus Clinical Research Corporation
Miami, Florida, United States

Quality Professional HealthCare
Miami, Florida, United States

Continental Clinical Research, LLC
Miami, Florida, United States

Global Life Research Network, Llc
Miami, Florida, United States

Sanitas Research, LLC
Miami, Florida, United States

US Associates in Research, LLC
Miami, Florida, United States

Biore'Search Institute Llc
Pembroke Pines, Florida, United States

Luminous Clinical Research - South Florida Urgent Care
Pembroke Pines, Florida, United States

Alliance Clinical Research of Tampa
Tampa, Florida, United States

University of Massachusettts Medical School
Worcester, Massachusetts, United States

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States

Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States

Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States

New Phase Research & Development
Knoxville, Tennessee, United States

Next Level Urgent Care
Houston, Texas, United States

Clinical Trial Network
Houston, Texas, United States

Frontier Clinical Research
Kingwood, West Virginia, United States

Centro de Pesquisas Clínicas de Natal
Natal, RN, Brazil

Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil

LMK Servicos Medicos S/S
Porto Alegre, RS, Brazil

Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, RS, Brazil

Pesquisare Saude S/S LTDA
Santo André, SP, Brazil

Centro Medico Mazzei
São Paulo, Brazil

Hospital Santa Paula
São Paulo, Brazil

Invesclinic Mx
Irapuato, Guanajuato, Mexico

Kohler & Milstein Research S.A. de C.V
Yucatán, Merida, Mexico

JM Research SC
Cuernavaca, Morelos, Mexico

Tecsi S.C.
Monterrey, Nuevo Leon, Mexico

Panamerican Clinical Research Mexico, S.A. de C. V.
Juriquilla, Queretaro, Mexico

Centro Medico Espiritu Santo
Tequisquiapan, Queretaro, Mexico

Appili Therapeutics Inc.
NCT Number
MeSH Terms
COVID-19
Favipiravir