- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04353518
Clinical Trial to Evaluate Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19
A Randomized, Double-blind, Two Arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Approximately eligible 4000 subjects who are at risk of getting infected with COVID-19 (i.e. person living in same household as COVID-19 patients / healthcare workers providing direct care to COVID-19 patients) will be enrolled in to the study after due consent and based on the eligibility criteria.
Initially, 400 subjects at risk of getting infected with COVID-19 will be enrolled in the study and randomized in 1:1 ratio to receive either Mw (n=200) or placebo (n=200). After the interim analysis from the data of these 400 subjects for safety and efficacy and based on review and recommendations from DSMB / MC, modification in study design, objective or sample size will be considered.
Study duration for each subject will be of 8 weeks.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sanjay Patel, MBBS
- Número de teléfono: 270 +912714221481
- Correo electrónico: sanjay.p@cadilapharma.co.in
Copia de seguridad de contactos de estudio
- Nombre: Ashish Amarsheda, M.Pharm
- Número de teléfono: +919898073861
- Correo electrónico: ashish.a@cadilapharma.co.in
Ubicaciones de estudio
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Chandigarh, India, 160012.
- Reclutamiento
- Post Graduate Institute of Medical Education and Research
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Contacto:
- Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
- Número de teléfono: 01722756823
- Correo electrónico: inderpgi@outlook.com
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Investigador principal:
- Inderpaul Singh Sehgal, DM (Pulmonary Medicine)
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Delhi, India, 110029
- Reclutamiento
- All lndia Institute of Medical Science, Delhi
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Contacto:
- Sushma Bhatnagar, MD (Anaesthesiology)
- Número de teléfono: 919811326453
- Correo electrónico: sushmabhatnagar1@gmail.com
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Investigador principal:
- Sushma Bhatnagar, MD (Anaesthesiology)
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Madhya Pradesh
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Bhopal, Madhya Pradesh, India, 462024
- Reclutamiento
- All India Institute of Medical Sciences, Bhopal
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Contacto:
- Sarman Singh, MD
- Número de teléfono: 917552672317
- Correo electrónico: director@aiimsbhopal.edu.in
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Investigador principal:
- Sarman Singh, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Healthy subjects of either gender, age ≥ 18 years, with recent history of close contact with COVID-19 patients.
- Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit.
- Female subject who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least months post-dosing.
- The subject must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.
Exclusion Criteria:
- Any febrile illness with oral temperature > 100°F within 3 days prior to randomization.
- Subject with past history of COVID-19 infection.
- Pregnant and / or lactating female subjects.
- Presence of any illness requiring hospital referral.
- Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressant's as Azathioprine, Cyclosporine, Mycophenolate etc.
- History of allergic reactions or anaphylaxis to Mw or its component.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Suspension of Mw
Intradermal suspension of Mw will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal Mw in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal Mw administered. |
Subjects randomized to Test arm will receive intraderma Mw in divided doses at least 2 cm away from first injection site in the deltoid region.
|
Comparador de placebos: Placebo
Placebo will be administered in two divided doses: Dose 1 at Day 0: 0.2 ml (0.1 ml x 2 injection) of intradermal placebo in two divided dose. Dose 2 at Day 15 after the first dose: 0.1 ml injection of intradermal placebo. |
Subjects randomized to placebo arm will receive intraderma Placebo in divided doses at least 2 cm away from first injection site in the deltoid region.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of subject acquiring COVID-19 infection
Periodo de tiempo: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..
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To compare proportion of subjects acquiring COVID-19 infection between two arms over the time till 8 weeks from administration of 1st dose
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing..
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of Adverse Event and Serious Adverse Event (safety and tolerability)
Periodo de tiempo: Till 8 weeks
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Any AE / SAE observed during the study.
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Till 8 weeks
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Number of subject developing Upper Respiratory Tract Infection (URTI) symptoms
Periodo de tiempo: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.
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Whether administration of Mw prevents development of Upper Respiratory Tract Infection (URTI) symptoms in close contacts of COVID-19 patients.
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing.
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Number of subject developing severe COVID-19 infection based on ordinal scale
Periodo de tiempo: From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing
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Whether administration of Mw prevents development of severe COVID-19 infection.
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From first dosing to week 1, week 2, week 4, week 8 or at any time during the study till 8 week post first dosing
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Anil Avhad, MBBS, Cadila Pharmaceuticals Limited
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRSC20005
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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