The Prevent Severe COVID-19 (PRESECO) Study

Covid19 Clinical Trial

— PRESECO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04600895
• Other study ID #: ATI0220
• Status: Completed
• Phase: Phase 3
• Start date: November 30, 2020
• Est. completion date: October 20, 2021

Study information

• Verified date: March 2024
• Source: Appili Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1187
• Est. completion date: October 20, 2021
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Favipiravir
Favipiravir
• Placebo
Placebo

Locations

Country	Name	City	State
Brazil	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
Mexico	JM Research SC	Cuernavaca	Morelos
Mexico	Invesclinic Mx	Irapuato	Guanajuato
Mexico	Panamerican Clinical Research Mexico, S.A. de C. V.	Juriquilla	Queretaro
Mexico	Tecsi S.C.	Monterrey	Nuevo Leon
Mexico	Centro Medico Espiritu Santo	Tequisquiapan	Queretaro
Mexico	Kohler & Milstein Research S.A. de C.V	Yucatán	Merida
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	Clinical Trial Network	Houston	Texas
United States	Next Level Urgent Care	Houston	Texas
United States	Frontier Clinical Research	Kingwood	West Virginia
United States	New Phase Research & Development	Knoxville	Tennessee
United States	B.G Clinical Research Center, LLC	Little Rock	Arkansas
United States	Continental Clinical Research, LLC	Miami	Florida
United States	Global Life Research Network, Llc	Miami	Florida
United States	Homestead Associates In Research	Miami	Florida
United States	Quality Professional HealthCare	Miami	Florida
United States	Sanitas Research, LLC	Miami	Florida
United States	US Associates in Research, LLC	Miami	Florida
United States	Verus Clinical Research Corporation	Miami	Florida
United States	Cahaba Research, Inc.	Pelham	Alabama
United States	Biore'Search Institute Llc	Pembroke Pines	Florida
United States	Luminous Clinical Research - South Florida Urgent Care	Pembroke Pines	Florida
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Absolute Clinical Research	Phoenix	Arizona
United States	Frontier Clinical Research, LLC	Scottdale	Pennsylvania
United States	Frontier Clinical Research, LLC	Smithfield	Pennsylvania
United States	Alliance Clinical Research of Tampa	Tampa	Florida
United States	University of Massachusettts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Appili Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Brazil,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of Subjects With COVID-19 Progression (Narrow Progression)	Proportion of subjects with COVID-19 progression, where progression is defined as the occurrence from study day 3 onward of any emergency department (ED) visit for COVID-19 worsening or shortness of breath OR hospitalization for COVID-19 worsening or shortness of breath OR death (narrow progression)	From study day 3 to day 28