Clinical trial NCT04600895: The Prevent Severe COVID-19 (PRESECO) Study
Official title: Favipiravir for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Lead sponsor: Appili Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 1187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Sustained Clinical Recovery
timeFrame: From Day 0 to Day 28
Secondary outcomes:
measure: Proportion of Subjects With COVID-19 Progression (Narrow Progression)
timeFrame: From study day 3 to day 28
Other outcomes:
Locations:
city: Pelham
country: United States
facility: Cahaba Research, Inc.
state: Alabama
city: Phoenix
country: United States
facility: Absolute Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: B.G Clinical Research Center, LLC
state: Arkansas
city: Boca Raton
country: United States
facility: Xera Med Research
state: Florida
city: Bradenton
country: United States
facility: Synergy Healthcare
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research,Inc.
state: Florida
city: Hollywood
country: United States
facility: Elixia Clinical Research Collaborative
state: Florida
city: Miami
country: United States
facility: Homestead Associates In Research
state: Florida
city: Miami
country: United States
facility: Verus Clinical Research Corporation
state: Florida
city: Miami
country: United States
facility: Quality Professional HealthCare
state: Florida
city: Miami
country: United States
facility: Continental Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Global Life Research Network, Llc
state: Florida
city: Miami
country: United States
facility: Sanitas Research, LLC
state: Florida
city: Miami
country: United States
facility: US Associates in Research, LLC
state: Florida
city: Pembroke Pines
country: United States
facility: Biore'Search Institute Llc
state: Florida
city: Pembroke Pines
country: United States
facility: Luminous Clinical Research - South Florida Urgent Care
state: Florida
city: Tampa
country: United States
facility: Alliance Clinical Research of Tampa
state: Florida
city: Worcester
country: United States
facility: University of Massachusettts Medical School
state: Massachusetts
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Scottdale
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Knoxville
country: United States
facility: New Phase Research & Development
state: Tennessee
city: Houston
country: United States
facility: Next Level Urgent Care
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Kingwood
country: United States
facility: Frontier Clinical Research
state: West Virginia
city: Natal
country: Brazil
facility: Centro de Pesquisas Clínicas de Natal
state: RN
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: LMK Servicos Medicos S/S
state: RS
city: Porto Alegre
country: Brazil
facility: Nucleo de Pesquisa Clinica do Rio Grande do Sul
state: RS
city: Santo André
country: Brazil
facility: Pesquisare Saude S/S LTDA
state: SP
city: São Paulo
country: Brazil
facility: Centro Medico Mazzei
city: São Paulo
country: Brazil
facility: Hospital Santa Paula
city: Irapuato
country: Mexico
facility: Invesclinic Mx
state: Guanajuato
city: Yucatán
country: Mexico
facility: Kohler & Milstein Research S.A. de C.V
state: Merida
city: Cuernavaca
country: Mexico
facility: JM Research SC
state: Morelos
city: Monterrey
country: Mexico
facility: Tecsi S.C.
state: Nuevo Leon
city: Juriquilla
country: Mexico
facility: Panamerican Clinical Research Mexico, S.A. de C. V.
state: Queretaro
city: Tequisquiapan
country: Mexico
facility: Centro Medico Espiritu Santo
state: Queretaro
Study officials:
References: