- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04358809
Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill
A Randomized, Double-blind, Two Arm, Controlled Clinical Trial to Compare the Efficacy and Safety of Mycobacterium w (Mw) Administered Along With Standard of Care Versus Placebo Administered Along With Standard of Care, in Adult, COVID 19 Positive Patients Hospitalized But Not Critically Ill.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Total 480 hospitalized adult eligible patients will be randomized in 1:1 ratio to receive either Mw+SOC or placebo+SOC for first 3 days post-randomization.
Daily clinical evaluation of patient will be performed till discharge from hospital or till ICU admission.
Study duration for each patient will be approximately up to 28 days, or discharge from hospital or transfer to ICU, whichever is earlier.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Bhopal, India
- 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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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 India Institute of Medical Sciences, Delhi
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Contacto:
- Anant Mohan, MD
- Número de teléfono: 911126588700
- Correo electrónico: anantmohan88@gmail.com
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Investigador principal:
- Anant Mohan, MD
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Chhattisgarh
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Raipur, Chhattisgarh, India, 492099
- Reclutamiento
- All India Institute of Medical Science, Raipur
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Contacto:
- Sajal De, MD
- Número de teléfono: 917712577372
- Correo electrónico: sajalde@yahoo.com
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Investigador principal:
- Sajal De, 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:
- COVID-19 positive patients with ordinal scale score of 3.
- Patients of either gender, age ≥ 18 years at the time of enrollment.
- Female patients 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 3 months post-dosing.
- The patients 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:
- Patient with ordinal scale of ≥4 at the time of hospital admission and randomization.
- Pregnant and / or lactating female patients.
- A family history of congenital or hereditary immunodeficiency.
- Any disease condition requiring ICU admission.
- History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator.
- History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period.
- History of allergic reactions or anaphylaxis to Mw or its component.
- Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patient's health or is likely to result nonconformance to the protocol or a patient's ability to give written informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Suspension of Mw + Standard therapy of COVID-19
0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days + Standard therapy of COVID-19
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Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19
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Comparador de placebos: Placebo
0.3 ml (0.1ml x 3 Injection) of intradermal Placebo for 3 consecutive days + Standard therapy of COVID-19
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Placebo along with Standard of care (SOC) treatment for COVID-19
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of patients with increased disease severity
Periodo de tiempo: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
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To compare the difference in proportion of patients with increased disease severity
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From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of adverse events and serious adverse events (Safety)
Periodo de tiempo: Till day 28
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To evaluate safety of Mw in COVID-19 patients admitted to hospital
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Till day 28
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Number of COVID-19 patients discharged from hospital
Periodo de tiempo: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
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To compare the proportion of patients discharged from hospital
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From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
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Number of COVID-19 patients transfer to ICU
Periodo de tiempo: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
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To compare the proportion of patients transfer to ICU
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From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
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Number of COVID-19 patients with reduction in disease severity by 1 ordinal scale
Periodo de tiempo: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
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To compare the proportion of patients with reduction in disease severity by 1 ordinal scale
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From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
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Number of of symptom free patients
Periodo de tiempo: From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
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To compare the proportion of symptom free patients
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From baseline to Day 3, Day 7, Day 14, Day 21, Day 28 or at any time during the study till 28 days post first dosing.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Sanjay Patel, 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
- CRSC20006
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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