Resumen

El propósito de este estudio es medir la proporción de participantes que se infectan con el coronavirus 2 del síndrome respiratorio agudo grave (SARS-CoV-2) (resultado positivo en la prueba de reacción en cadena de la polimerasa con transcripción inversa [RT-PCR]) y presentan síntoma(s) de la enfermedad por coronavirus 2019 (COVID-19) con comprimidos de S-217622 en comparación con comprimidos de placebo, en participantes que son contactos domiciliarios de un individuo con COVID-19 sintomático.

Descripción detallada

Este estudio incorporará dos tipos de participantes: 1. aquellos con un resultado negativo en la selección para infección por SARS-CoV-2 (denominados "participantes del estudio"); 2. aquellos con un resultado positivo en la selección para infección por SARS-CoV-2 (denominados "participantes índice"). Los participantes del estudio recibirán la intervención del estudio (S-217622 o placebo); los participantes índice no recibirán ninguna intervención del estudio.

Elegibilidad

Sexo: ALL

Criterios de inclusión

Index Participants
Only 1 index participant from each household will be enrolled in the study. Participants are eligible to be included as an index participant if all of the following criteria apply:
Pediatric participants or adult participants (of any age)
The index participant must:
Have at least 1 COVID-19 symptom within 24 hours before the index participant providing informed consent. COVID-19 symptom(s) must be deemed by the investigator as related to the current SARS-CoV-2 infection (not related to preexisting comorbidities) or deemed as preexisting and worsened due to SARS-CoV-2 infection.
Must have positive SARS-CoV-2 test (a nucleic acid amplification test or antigen test) from any respiratory tract specimen from a sample collected prior to randomization of the participant
Must have a potential study participant who can participate in the study after onset of COVID-19 symptoms in an index participant
Study Participants
Multiple study participants from the same household are allowed to be enrolled in the study. The study intervention randomization will be performed based at the study participant's level. Participants will be eligible to be included in the study only if all of the following criteria apply:
≥ 12 years of age at the time of signing the informed consent
Has a negative screening for SARS-CoV-2 infection, as determined by SARS-CoV-2 test (a nucleic acid amplification test or antigen test) from any respiratory tract specimen (for example, oropharyngeal, nasopharyngeal or nasal swab, or saliva).
Has lived in household with index participant and will continue to live in same household and share common areas such as dining rooms and bathrooms until the end of the study
Must not be considered by the investigator or subinvestigator to have SARS-CoV-2 infection and:
No measured fever at Screening (defined as body temperature ≥ 38.0°Celsius \[C\] per tympanic or rectal thermometer or ≥ 37.5°C per axillary, oral, or forehead/temporal thermometer)
No COVID-19 symptoms at Screening (if a participant has COVID-19-like symptoms caused by comorbidities, only 1 symptom will be allowed)
Capable and willing to complete a participant diary
a. Male participants: Participants with partners that are woman of childbearing potential (WOCBP) must agree to use effective contraception. Participants with pregnant partners must agree to use effective contraception.
b. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and the following conditions applies:
Is not a WOCBP or
All of the following apply:
Is a WOCBP and using a contraceptive method that is effective as described in the protocol.
A WOCBP must have a negative urine pregnancy test within 24 hours before the first dose of study intervention period.
If a urine pregnancy test cannot be confirmed as negative (for example, an ambiguous result), a serum pregnancy test must be negative.
Additional requirements for pregnancy testing during and after study intervention as described in the protocol.
The investigator/subinvestigator will review medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with an early undetected pregnancy.
Participant must be randomized ≤ 72 hours from onset of COVID-19 symptoms in the index participant.

Criterios de exclusión

Study Participants: Participants will be excluded from the study if any of the following criteria apply:
Tested positive for SARS-CoV-2 in the past 6 months.
Have an underlying disease requiring systemic corticosteroids (excluding topical), antipyretics/analgesics, or immunosuppressive agents.
Known current renal impairment defined as creatinine clearance \< 30 milliliters/minute by Cockcroft Gault or requiring dialysis.
Participants with severe liver dysfunction, such as known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
Received approved, authorized, or investigational convalescent plasma, or other anti- SARS-CoV-2 biologic products within 3 months of the Screening Visit
Received approved, authorized, or investigational anti-SARS-CoV-2 monoclonal antibodies (mAbs) in the last 6 months.
Received any SARS-CoV-2 vaccine within 6 months prior to the Screening Visit or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments until the end of the study.
Participants who have used any of the following drugs within 14 days prior to enrollment:
Strong cytochrome P450 (CYP) 3A inducer
Products containing St. John's wort
Exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to the Screening Visit.
Positive urine pregnancy test at Screening Visit or are lactating.
Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622.
Any condition or circumstance that, in the opinion of the investigator or subinvestigator, would compromise the safety of the participant or the quality of the study data.

Ubicaciones

Hospital Interzonal General de Agudos Vicente Lopez Y Planes

General Rodríguez, Buenos Aires, Argentina

Clínica Privada Independencia

Munro, Buenos Aires, Argentina

Centro Médico San Nicolás Grupo Oroño

San Nicolás de los Arroyos, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Zárate

Zárate, Buenos Aires, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

INECO Neurociencias Oroño

Rosario, Santa Fe Province, Argentina

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Santa Fe Province, Argentina

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Rawson

Córdoba, Argentina

Sanatorio Allende S.A