Public trial
RBR-4vm3yy Effect of convalescent plasma in patients with severe COVI-19
Date of registration: 05/15/2020 (mm/dd/yyyy)Last approval date : 05/15/2020 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Use of convalescent plasma submitted to pathogen inactivation for the treatment of patients with severe COVID-19
pt-br
Uso de plasma convalescente submetido à inativação de patógenos para o tratamento de pacientes com COVID-19 grave
Trial identification
- UTN code: U1111-1251-9286
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Public title:
en
Effect of convalescent plasma in patients with severe COVI-19
pt-br
Efeito do plasma convalescente em pacientes graves com COVID-19 grave
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Scientific acronym:
-
Public acronym:
-
Secondaries identifiers:
-
30487220.8.1001.5267 - CAAE
Issuing authority: Plataforma Brasil
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3.980.508
Issuing authority: Comitê de Ética em Pesquisa do Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti
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30487220.8.1001.5267 - CAAE
Sponsors
- Primary sponsor: Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti
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Secondary sponsor:
- Institution: Paulo Niemeyer State Brain Institute
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Supporting source:
- Institution: Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti
Health conditions
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Health conditions:
en
Coronavirus infection; Sepsis
pt-br
Infecções por Coronavirus; Sepse
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General descriptors for health conditions:
en
C01 Infections
pt-br
C01 Infecções
es
C01 Infecciones
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Specific descriptors:
Interventions
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Interventions:
en
Hyperimmune plasma anti-SARS-CoV-2 20 patients will be included and will be compared with historical controls, that were admitted before the start of the current study
pt-br
Plasma hiper-imune ANTI-SARS-CoV-2 20 pacientes serão incluídos e serão comparados com controles históricos, antes do início do estudo
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Descriptors:
en
E02.095.465.425.400.330 Immunization, Passive
pt-br
E02.095.465.425.400.330 Imunização Passiva
es
E02.095.465.425.400.330 Inmunización Pasiva
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 04/19/2020 (mm/dd/yyyy)
- Date last enrollment: 05/31/2020 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 20 - 18 Y 0 - -
Inclusion criteria:
en
Age > or equal to 18 years; Severe or critical-19 COVID-19; Length of stay < 3 days; Laboratory confirmation of COVID-19 by detection of the viral genome in respiratory secretions, collected by swab; Signature, by the patient or a relative, of the informed consent form
pt-br
Idade > ou igual a 18 anos; COVID-19 grave ou crítica; Tempo de internação < 3 dias; Confirmação laboratorial de COVID-19, pela detecção do genoma viral em secreções respiratórias, colhidas por swab; Assinatura, pelo paciente ou por um familiar, do termo de consentimento livre e esclarecido
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Exclusion criteria:
en
Allergic reactions prior to plasma transfusion
pt-br
Reações alérgicas prévias à transfusão de plasma
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 Treatment Single-group 1 Open Single-arm-study N/A
Outcomes
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Primary outcomes:
en
Temporal improvement in inflammatory biomarkers and organ dysfunction scores during ICU admission, measured by the daily reduction in 10% of biomarkers in plasma and respiratory secretions, per day for 14 days
pt-br
Melhora temporal dos marcadores inflamatórios e de disfunção orgânica durante a internação na UTI, avaliada pela redução de 10% na mensuração diária de biomarcadores plasmáticos e nas secreções respiratórias, a cada dia nos primeiros 14 dias
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Secondary outcomes:
en
Reduction of 10% in mechanical ventilations days, measured by ventilation-free days during the first 14 days
pt-br
Redução de 10% no tempo de ventilação mecânica, medido pelos dias livres de ventilação mecânica nos primeiros 14 dias
en
Reduction of 5% in in-hospital mortality, measured by the frequency of deaths during hospital admission
pt-br
Redução absoluta de 5% na mortalidade hospitalar, medida pelo percentual de óbitos ocorridos durante a internação
en
Reduction of 10% in ICU length of stay, measured by days of ICU and hospital admission
pt-br
Redução de 10% no tempo de de internação na UTI e no hospital, medido pelo número de dias internados no hospital
Contacts
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Public contact
- Full name: Pedro Kurtz
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- Address: Rua do Resende 156
- City: Rio de Janeiro / Brazil
- Zip code: 20092-231
- Phone: +5502122779352
- Email: kurtzpedro@mac.com
- Affiliation: Instituto Estadual do Cérebro Paulo Niemeyer
- Full name: Pedro Kurtz
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- Address: Rua do Resende 156
- City: Ro de Janeiro / Brazil
- Zip code: 20231092
- Phone: 2122779352
- Email: kurtzpedro@mac.com
- Affiliation: Instituto Estadual do Cérebro Paulo Niemeyer
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Scientific contact
- Full name: Pedro Kurtz
-
- Address: Rua do Resende 156
- City: Ro de Janeiro / Brazil
- Zip code: 20231092
- Phone: 2122779352
- Email: kurtzpedro@mac.com
- Affiliation: Instituto Estadual do Cérebro Paulo Niemeyer
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Site contact
- Full name: Pedro Kurtz
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- Address: Rua do Resende 156
- City: Ro de Janeiro / Brazil
- Zip code: 20231092
- Phone: 2122779352
- Email: kurtzpedro@mac.com
- Affiliation: Instituto Estadual do Cérebro Paulo Niemeyer
Additional links:
Total de Ensaios Clínicos 12637.
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