Resumen

Los objetivos primarios de este estudio son evaluar la seguridad, tolerabilidad y eficacia de BGE-175 en participantes ≥ 50 años de edad hospitalizados con COVID-19 confirmado.

Descripción detallada

Este es un estudio aleatorizado, controlado con placebo, de grupos paralelos, multicéntrico, doble ciego de BGE-175 administrado por vía oral (PO) o sonda nasogástrica (NG) en participantes ≥ 50 años de edad hospitalizados con COVID-19 confirmado que aún no presentan insuficiencia respiratoria. Tras la firma del consentimiento informado, los participantes serán evaluados en el momento de su presentación en el hospital. El tamizaje incluirá examen físico completo, signos vitales, evaluaciones de laboratorio de seguridad, saturación de oxígeno, prediagnósticos para medir el estado de la prostaglandina D2 (PGD2) y evaluación basal de la Escala Ordinal de la Organización Mundial de la Salud (OMS) para COVID-19. Si se confirma que el participante cumple con este protocolo de acuerdo con los criterios de inclusión y exclusión enumerados, recibirá la primera dosis del medicamento del estudio por vía oral. A continuación, el participante recibirá el medicamento del estudio por vía oral o sonda nasogástrica (si está intubado o no puede deglutir el medicamento) una vez al día, aproximadamente a la misma hora cada día, durante hasta 13 días adicionales. El medicamento del estudio se administrará además del tratamiento estándar considerado apropiado por el o los médicos tratantes. Los participantes serán aleatorizados para recibir BGE-175 o placebo. Los participantes serán monitoreados diariamente para todos los desenlaces de eficacia relevantes, saturación de oxígeno y eventos adversos. Se extraerán muestras de sangre periódicamente para mediciones de laboratorio de seguridad, cinética plasmática, subpoblaciones de linfocitos, proteína C reactiva y citocinas. Se recolectarán hisopados nasofaríngeos para medir la carga viral. Los participantes serán monitoreados durante 14 días después de la administración de la última dosis (Día 28) y se realizará seguimiento hasta el Día 57.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Ability to voluntarily provide informed consent that is documented per local requirements
An understanding, ability, and willingness to fully comply with study procedures and restrictions
Hospitalized subjects with a confirmed SARS-CoV-2 infection
Laboratory (polymerase chain reaction \[PCR\]) confirmed infection with SARS-CoV-2
Age ≥ 50 years
COVID-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (Note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%)
Not in respiratory failure as defined by at least one of the following:
Respiratory failure defined by requiring at least one of the following:
Endotracheal intubation and mechanical ventilation
Oxygen delivered by high-flow nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5)
NIPPV
ECMO
Clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting)
Hemodynamic compromise (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg) or requiring vasopressors
Multi-organ dysfunction/failure
Females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on Day 1
Male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies

Criterios de exclusión

Participation in any other randomized, controlled clinical trial of an experimental treatment for COVID-19 (uncontrolled, compassionate use trials are allowed)
In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
Currently participating in a vaccination trial for SARS-CoV-2
Known positive test for influenza A or influenza B at the time of screening
Positive for human immunodeficiency virus (HIV) that is not controlled with current treatment
Hepatitis B surface antigen, or Hepatitis C positive at the time of screening. Subjects who are positive for Hepatitis C but have Hepatitis C virus (HCV) RNA below the limit of quantitation may be enrolled. Subjects with Hepatitis B, but with undetectable viral load, may be enrolled.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 × the upper limit of normal (ULN)
Stage 4 severe chronic kidney disease (i.e., estimated glomerular filtration rate \[eGFR\] \< 30 mL/min) or acute renal failure resulting in eGFR \< 30 mL/min
Serious comorbidity, including:
Myocardial infarction (within the last month)
Moderate or severe heart failure (New York Heart Association \[NYHA\] class III or IV)
Acute stroke (within the last month)
Uncontrolled malignancy. Uncontrolled malignancy would include cancers that are not considered in remission, or solid tumor or hematological malignancies with evidence of disease progression in the past 3 months (i.e., there is evidence of disease progression by Response Evaluation Criteria in Solid Tumours \[RECIST\] or equivalent relevant criterion for the type of malignancy), and are not considered effectively managed with ongoing treatment as determined by the investigator
Recent severe thromboembolic disease or evidence of severe thromboembolic disease defined as a current large vessel thromboembolic event or a thromboembolic event within the past 3 months (e.g., deep vein thrombosis \[DVT\], pulmonary embolism, ischemic stroke, transient ischemic attack) requiring interventional treatment. This exclusion does not prohibit prophylaxis for thromboembolic events, including those considered possible with concurrent SARS-CoV-2 infection.
History of severe allergic or anaphylactic reactions or hypersensitivity to the study drug
Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment

Estudio de fase 2, multicéntrico, aleatorizado, doble ciego, controlado con placebo para investigar la eficacia y seguridad de BGE-175 en adultos hospitalizados con COVID-19

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

BGE-175

Placebo

Ubicaciones

Clinica Privada Independencia

Sanatorio De La Trinidad Mitre

Clinica Adventista Belgrano (CAB)

Patrocinadores