The Prevent Severe COVID-19 (PRESECO) Study

NCT ID: NCT04600895

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-30
• Study Completion Date: 2021-10-20

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Favipiravir

Favipiravir 200mg tablet

Group Type: EXPERIMENTAL

Favipiravir

Intervention Type: DRUG

Favipiravir

Placebo

Placebo 200mg tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Favipiravir

Favipiravir

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Appili Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

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, Rio Grande do Norte, Brazil

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

LMK Servicos Medicos S/S

Porto Alegre, Rio Grande do Sul, Brazil

Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Pesquisare Saude S/S LTDA

Santo André, São Paulo, 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 León, Mexico

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

Juriquilla, Querétaro, Mexico

Centro Medico Espiritu Santo

Tequisquiapan, Querétaro, Mexico

Countries

United States; Brazil; Mexico

References

Golan Y, Campos JAS, Woolson R, Cilla D, Hanabergh R, Gonzales-Rojas Y, Lopez R, Finberg R, Balboni A. Favipiravir in Patients With Early Mild-to-moderate Coronavirus Disease 2019 (COVID-19): A Randomized Controlled Trial. Clin Infect Dis. 2023 Feb 8;76(3):e10-e17. doi: 10.1093/cid/ciac712.

Reference Type: DERIVED

PMID: 36065065 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ATI0220

Identifier Type: -

Identifier Source: org_study_id