Resumen

The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Have chronic kidney disease
Have type 1 or type 2 diabetes
Have immunosuppressive disease
Are currently receiving immunosuppressive treatment
For low-risk participant arms 9-11 only: Are greater than or equal to (≥)18 and less than (\<)65 years of age at the time of randomization and do not have the risk factors defined in the bullet point directly below
For high-risk participant arms 12 and 13 only:
\-- Are ≥18 years of age and satisfy at least one of the following risk factors at the time of screening
Are ≥65 years of age
Have a body mass index (BMI) ≥ 35
Have chronic kidney disease
Have type 1 or type 2 diabetes
Have immunosuppressive disease
Are currently receiving immunosuppressive treatment, or
Are ≥55 years of age AND have
cardiovascular disease, OR
hypertension, OR
chronic obstructive pulmonary disease or other chronic respiratory disease
For high-risk participant arms 12 and 13 only:
Are 12-17 years of age (inclusive) AND satisfy at least one of the following risk factors at the time of screening
Have a BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical\_charts.htm
Have sickle cell disease
Have congenital or acquired heart disease
Have neurodevelopmental disorders, for example, cerebral palsy
Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
Have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control
Have type 1 or type 2 diabetes
Have chronic kidney disease
Have immunosuppressive disease, or
Are currently receiving immunosuppressive treatment.
For high-risk participants arm 14 only:
Are ≥12 years of age and satisfy at least one of the following risk factors at the time of screening Are ≥65 years of age
Are adults (≥18 years of age) with BMI \>25 kg/m2 , or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts
Have cardiovascular disease (including congenital heart disease) or hypertension
Have chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma \[moderate-to-severe\], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
Have sickle cell disease
Have neurodevelopmental disorder (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
Have a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation \[not related to COVID-19\]
Are currently not hospitalized
Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion, nasal congestion or runny nose, new loss of smell, chills
Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
Are men or non-pregnant women who agree to contraceptive requirements
Understand and agree to comply with planned study procedures
Agree to the collection of nasopharyngeal swabs and venous blood
The participant or legally authorized representative give signed informed consent and/or assent

Criterios de exclusión

For low-risk participants only: BMI ≥35
Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) \<300, respiratory rate ≥30 per minute, heart rate ≥125 per minute
Require mechanical ventilation or anticipated impending need for mechanical ventilation
Have known allergies to any of the components used in the formulation of the interventions
Have hemodynamic instability requiring use of pressors within 24 hours of randomization
Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
Have any co-morbidity requiring surgery within \<7 days, or that is considered life-threatening within 29 days
Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
Have a history of a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test prior to the one serving as eligibility for this study
Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
Have received treatment with a SARS-CoV-2 specific monoclonal antibody
Have a history of convalescent COVID-19 plasma treatment
For low-risk arms only: have received a SARS-CoV-2 vaccine or have participated in a previous SARS-CoV-2 vaccine study and are currently blinded to treatment allotment
Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Are pregnant or breast feeding
Are investigator site personnel directly affiliated with this study
Have body weight \<40 kilograms

Ubicaciones

Sanatorio Sagrado Corazón

Ciudad de Buenos Aires, AR, Argentina

Clínica Zabala

Ciudad de Buenos Aires, AR, Argentina

Sanatorio de la Trinidad Mitre

CABA, Buenos Aires, Argentina

Clínica Privada Independencia

Munro, Buenos Aires, Argentina

Go Centro Medico San Nicolás

San Nicolás de los Arroyos, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Zarate

Zárate, Buenos Aires, Argentina

Instituto Médico Rio Cuarto

Río Cuarto, Córdoba Province, Argentina

Centro de Investigaciones Clínicas - Clínica Viedma

Viedma, Río Negro Province, Argentina

Clinica Central S.A.

Villa Regina, Río Negro Province, Argentina

INECO Neurociencias Oroño

Rosario, Santa Fe Province, Argentina

Hospital San Roque

Córdoba, Argentina

A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy With Monoclonal Antibodies in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Bamlanivimab

Etesevimab

Placebo

VIR-7831

Bebtelovimab