Public trial
RBR-25rtydq Tocilizumab role in reducing the complications of COVID patients
Date of registration: 08/11/2021 (mm/dd/yyyy)Last approval date : 08/11/2021 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Tocilizumab role in reducing the complications of COVID patients
pt-br
Papel do tocilizumabe na redução das complicações de pacientes com COVID
es
Tocilizumab role in reducing the complications of COVID patients
Trial identification
- UTN code:
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Public title:
en
Tocilizumab role in reducing the complications of COVID patients
pt-br
Papel do tocilizumabe na redução das complicações de pacientes com COVID
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Scientific acronym:
en
TOCIPAK
pt-br
TOCIPAK
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Public acronym:
en
TOCIPAK
pt-br
TOCIPAK
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Secondaries identifiers:
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U1111-1268-3185
Issuing authority:
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Ethics Committee approval protocol number
Issuing authority: 443-1/LRH/MTI
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U1111-1268-3185
Sponsors
- Primary sponsor: Lady Reading Hospital-MTI Peshawar
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Secondary sponsor:
- Institution: Department of Pharmacy Services
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Supporting source:
- Institution: Lady Reading Hospital-MTI Peshawar
Health conditions
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Health conditions:
en
Pneumonia due to COVID-19
pt-br
Pneumonia devido a COVID-19
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General descriptors for health conditions:
en
B34.2 Unspecified acute lower respiratory infection
pt-br
B34.2 Infecção respiratória inferior aguda não especificada
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Specific descriptors:
en
J12.82 Pneumonia due to COVID-19
pt-br
J12.82 Pneumonia devido a COVID-19
Interventions
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Interventions:
en
Single Arm Study: 59 patients admitted for the treatment of COVID-19 patients receive tocilizumab as a dose of 400 mg intravenously in 100 mL NaCl 0.9 % administered in 60 minutes as intervention. Control Group: No control group
pt-br
Estudo de braço único: 59 pacientes admitidos para o tratamento de pacientes com COVID-19 receberam tocilizumabe como uma dose de 400 mg por via intravenosa em 100 mL de NaCl 0,9% administrado em 60 minutos como intervenção. Grupo de controle: Sem grupo de controle
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Descriptors:
en
D26.670 Prescription Drugs
pt-br
D26.670 Medicamentos sob Prescrição
Recruitment
- Study status: Recruitment completed
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Countries
- Pakistan
- Date first enrollment: 04/16/2020 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 59 - 17 Y 0 -
Inclusion criteria:
en
Confirmed or suspected SARS-CoV infection; Adult patient; Moderate to Critical COVID Patients
pt-br
Infecção confirmada ou suspeita de SARS-CoV; Paciente adulto; Pacientes COVID moderados a críticos
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Exclusion criteria:
en
Known hypersensitivity to Tocilizumab or its excipients; patient below 18 years; mild cases of Confirmed or suspected SARS-CoV
pt-br
Hipersensibilidade conhecida ao Tocilizumab ou seus excipientes; paciente menor de 18 anos; casos leves de SARS-CoV confirmados ou suspeitos
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Treatment Single-group 1 Open Single-arm-study 3
Outcomes
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Primary outcomes:
en
Rate of mortality in patients receiving tocilizumab in the hospital, verified by chi square test, it was observed that patients receiving invasive respiratory support were identified to higher risk of mortality than patients receiving oxygen support ( (50 vs 86, p<0.05)
pt-br
Taxa de mortalidade em pacientes recebendo tocilizumabe no hospital, verificada pelo teste do qui-quadrado, observou-se que os pacientes recebendo suporte respiratório invasivo foram identificados com maior risco de mortalidade do que os pacientes recebendo suporte de oxigênio ((50 vs 86 p <0,05)
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Secondary outcomes:
en
Secondary outcomes are not expected
pt-br
Não são esperados desfechos secundários
Contacts
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Public contact
- Full name: Muhammad Amir
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- Address: Lady Reading Hospital, Peshawar
- City: Peshawr / Pakistan
- Zip code: 75290|
- Phone: ++92-334-3266804
- Email: mohd_amir80@hotmail.com
- Affiliation:
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Scientific contact
- Full name: Muhammad Amir
-
- Address: Lady Reading Hospital, Peshawar
- City: Peshawr / Pakistan
- Zip code: 75290|
- Phone: ++92-334-3266804
- Email: mohd_amir80@hotmail.com
- Affiliation:
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Site contact
- Full name: Muhammad Amir
-
- Address: Lady Reading Hospital, Peshawar
- City: Peshawr / Pakistan
- Zip code: 75290|
- Phone: ++92-334-3266804
- Email: mohd_amir80@hotmail.com
- Affiliation:
Additional links:
Total de Ensaios Clínicos 16962.
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