The Prevent Severe COVID-19 (PRESECO) Study

Phase 3

Completed

Conditions: Covid19

Interventions: Drug: Favipiravir
Drug: Placebo

Registration Number: NCT04600895

Lead Sponsor: Appili Therapeutics Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1187

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Favipiravir	Favipiravir	Favipiravir 200mg tablet
Placebo	Placebo	Placebo 200mg tablet

Primary Outcome Measures

Name	Time	Method
Number of Participants With Sustained Clinical Recovery	From Day 0 to Day 28	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects With COVID-19 Progression (Narrow Progression)	From study day 3 to day 28	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)

Trial Locations

Locations (37): Quality Professional HealthCare
🇺🇸
Miami, Florida, United States
Continental Clinical Research, LLC
🇺🇸
Miami, Florida, United States
Sanitas Research, LLC
🇺🇸
Miami, Florida, United States
US Associates in Research, LLC
🇺🇸
Miami, Florida, United States
Clinical Trial Network
🇺🇸
Houston, Texas, United States
Homestead Associates In Research
🇺🇸
Miami, Florida, United States
Verus Clinical Research Corporation
🇺🇸
Miami, Florida, United States
B.G Clinical Research Center, LLC
🇺🇸
Little Rock, Arkansas, United States
Next Level Urgent Care
🇺🇸
Houston, Texas, United States
Tecsi S.C.
🇲🇽
Monterrey, Nuevo Leon, Mexico
Centro Medico Espiritu Santo
🇲🇽
Tequisquiapan, Queretaro, Mexico
Nucleo de Pesquisa Clinica do Rio Grande do Sul
🇧🇷
Porto Alegre, RS, Brazil
Hospital Santa Paula
🇧🇷
São Paulo, Brazil
Panamerican Clinical Research Mexico, S.A. de C. V.
🇲🇽
Juriquilla, Queretaro, Mexico
Invesclinic Mx
🇲🇽
Irapuato, Guanajuato, Mexico
JM Research SC
🇲🇽
Cuernavaca, Morelos, Mexico
Centro de Pesquisas Clínicas de Natal
🇧🇷
Natal, RN, Brazil
Kohler & Milstein Research S.A. de C.V
🇲🇽
Yucatán, Merida, Mexico
Frontier Clinical Research
🇺🇸
Kingwood, West Virginia, United States
Hospital de Clinicas de Porto Alegre
🇧🇷
Porto Alegre, RS, Brazil
Global Life Research Network, Llc
🇺🇸
Miami, Florida, United States
LMK Servicos Medicos S/S
🇧🇷
Porto Alegre, RS, Brazil
Pesquisare Saude S/S LTDA
🇧🇷
Santo André, SP, Brazil
Centro Medico Mazzei
🇧🇷
São Paulo, Brazil
Cahaba Research, Inc.
🇺🇸
Pelham, Alabama, United States
Synergy Healthcare
🇺🇸
Bradenton, Florida, United States
Xera Med Research
🇺🇸
Boca Raton, Florida, United States
Best Quality Research,Inc.
🇺🇸
Hialeah, Florida, United States
Elixia Clinical Research Collaborative
🇺🇸
Hollywood, Florida, United States
Biore'Search Institute Llc
🇺🇸
Pembroke Pines, Florida, United States
Luminous Clinical Research - South Florida Urgent Care
🇺🇸
Pembroke Pines, Florida, United States
University of Massachusettts Medical School
🇺🇸
Worcester, Massachusetts, United States
Thomas Jefferson University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
Frontier Clinical Research, LLC
🇺🇸
Smithfield, Pennsylvania, United States
New Phase Research & Development
🇺🇸
Knoxville, Tennessee, United States
Alliance Clinical Research of Tampa
🇺🇸
Tampa, Florida, United States
Absolute Clinical Research
🇺🇸
Phoenix, Arizona, United States