The Prevent Severe COVID-19 (PRESECO) Study

NCT04600895 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: ATI0220
• Study Type: interventional
• Target: 1,187
• Locations: 3 countries
• Sites: 38

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Sustained Clinical Recovery

  The endpoint will be considered to have been met at the earliest time point at which the subject has reached Sustained Alleviation of Symptoms (Symptoms related to smell or taste are not included in the primary endpoint) reported by the patient have reached a severity of "0 - none" or "1 - mild" in assessments for 4-point scale assessments and not known to have redeveloped any COVID-19 associated signs and symptoms (not including reduced sense of taste or smell) in a severity beyond mild for 4 consecutive days when assessed from the start of study treatment to day 28. To meet the primary endpoint, subjects must survive with no hospitalization to day 28.

  From Day 0 to Day 28

Secondary Outcomes (1)

• Proportion of Subjects With COVID-19 Progression (Narrow Progression)

  From study day 3 to day 28

Study Arms (2)

Favipiravir

EXPERIMENTAL

Favipiravir 200mg tablet

Drug: Favipiravir

Placebo

PLACEBO COMPARATOR

Placebo 200mg tablet

Drug: Placebo

Interventions

Favipiravir DRUG

Favipiravir

Favipiravir

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Appili Therapeutics Inc.: lead

Study Sites (38)

Cahaba Research, Inc.

Pelham, Alabama, 35124, United States

Location

Absolute Clinical Research

Phoenix, Arizona, 85051, United States

Location

B.G Clinical Research Center, LLC

Little Rock, Arkansas, 72205, United States

Location

Xera Med Research

Boca Raton, Florida, 33487, United States

Location

Synergy Healthcare

Bradenton, Florida, 34208, United States

Location

Best Quality Research,Inc.

Hialeah, Florida, 33016, United States

Location

Elixia Clinical Research Collaborative

Hollywood, Florida, 33023, United States

Location

Homestead Associates In Research

Miami, Florida, 33032, United States

Location

Verus Clinical Research Corporation

Miami, Florida, 33125, United States

Location

Quality Professional HealthCare

Miami, Florida, 33126, United States

Location

Continental Clinical Research, LLC

Miami, Florida, 33144, United States

Location

Global Life Research Network, Llc

Miami, Florida, 33155, United States

Location

Sanitas Research, LLC

Miami, Florida, 33155, United States

Location

US Associates in Research, LLC

Miami, Florida, 33175, United States

Location

Biore'Search Institute Llc

Pembroke Pines, Florida, 33026, United States

Location

Luminous Clinical Research - South Florida Urgent Care

Pembroke Pines, Florida, 33029, United States

Location

Alliance Clinical Research of Tampa

Tampa, Florida, 33615, United States

Location

University of Massachusettts Medical School

Worcester, Massachusetts, 01655, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683, United States

Location

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States

Location

New Phase Research & Development

Knoxville, Tennessee, 37909, United States

Location

Next Level Urgent Care

Houston, Texas, 77057, United States

Location

Clinical Trial Network

Houston, Texas, 77074, United States

Location

Frontier Clinical Research

Kingwood, West Virginia, 26537, United States

Location

Centro de Pesquisas Clínicas de Natal

Natal, Rio Grande do Norte, Brazil

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

LMK Servicos Medicos S/S

Porto Alegre, Rio Grande do Sul, Brazil

Location

Nucleo de Pesquisa Clinica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Pesquisare Saude S/S LTDA

Santo André, São Paulo, Brazil

Location

Centro Medico Mazzei

São Paulo, Brazil

Location

Hospital Santa Paula

São Paulo, Brazil

Location

Invesclinic Mx

Irapuato, Guanajuato, Mexico

Location

Kohler & Milstein Research S.A. de C.V

Yucatán, Merida, Mexico

Location

JM Research SC

Cuernavaca, Morelos, Mexico

Location

Tecsi S.C.

Monterrey, Nuevo León, Mexico

Location

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

Juriquilla, Querétaro, Mexico

Location

Centro Medico Espiritu Santo

Tequisquiapan, Querétaro, Mexico

Location

Related Publications (1)

• 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.

  PMID: 36065065 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

favipiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Prasann Bavaniya, MS-BioTech
• Organization: Appili Therapeutics Inc

pbavaniya@appilitherapeutics.com

902-442-4655

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 23, 2020
• Study Start: November 30, 2020
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: March 29, 2024
• Results First Posted: March 29, 2024

Record last verified: 2024-03

Locations

US (25); BR (7); ME (6)