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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

                                
    
                                    
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                                        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:
    
                                        
    
                                                                                                                                
    
                                    
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    Public acronym:
    
                                        
    
                                                                                                                                
    
                                    
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                                        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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Sponsors

                                
    
                                    
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                                        Primary sponsor:
                                        Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti 
                                    
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                                        Secondary sponsor:
                                                                                                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Paulo Niemeyer State Brain Institute
                                                
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                                        Supporting source:
                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti 
                                                
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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:
    
                                                                                
     
    
                                    
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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
                                                    
    
                                                    
                                            
     
    
                                    
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Recruitment

                                
    
                                    
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                                        Study status:
                                                                                Recruiting
                                    
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                                        Countries
                                        
      
                                            
    • Brazil
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                                        Date first enrollment:
                                        
                                                                                        04/19/2020                                            (mm/dd/yyyy)
                                        

                                    
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                                        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 -
                                            
    
                                            
    
                                    
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    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 

    
                                                
                                            
    
                                    
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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
                                            
    
                                                
                                        
    
                                    
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Outcomes

                                
    
                                    
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    Primary outcomes:
    
                                        
    
                                                    
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                                                        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  


                                                
    
                                                
                                            
     
    
                                    
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Contacts

                                
    

                                    
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                                        Public contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Pedro   Kurtz
                                                
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                                                            Address:
                                                            Rua do Resende 156
                                                        
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                                                            City: 
                                                            Rio de Janeiro / Brazil
                                                        
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                                                            Zip code:
                                                            20092-231
                                                        
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                                                    Phone:
                                                    +5502122779352
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Instituto Estadual do Cérebro Paulo Niemeyer 
                                                
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                                                    Full name:
                                                    Pedro  Kurtz 
                                                
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                                                            Address:
                                                            Rua do Resende 156 
                                                        
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                                                            City: 
                                                            Ro de Janeiro  / Brazil
                                                        
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                                                            Zip code:
                                                            20231092
                                                        
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                                                    Phone:
                                                    2122779352
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Instituto Estadual do Cérebro Paulo Niemeyer 
                                                
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                                        Scientific contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Pedro  Kurtz 
                                                
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                                                            Address:
                                                            Rua do Resende 156 
                                                        
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                                                            City:
                                                            Ro de Janeiro  / Brazil
                                                        
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                                                            Zip code:
                                                            20231092
                                                        
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                                                    Phone:
                                                    2122779352
                                                
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                                                    Email:
                                                    
                                                
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                                                    Affiliation:
                                                    Instituto Estadual do Cérebro Paulo Niemeyer 
                                                
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                                        Site contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Pedro  Kurtz 
                                                
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      • 
                                                            Address:
                                                            Rua do Resende 156 
                                                        
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                                                            City:
                                                            Ro de Janeiro  / Brazil
                                                        
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      • 
                                                            Zip code:
                                                            20231092
                                                        
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    • 
                                                    Phone:
                                                    2122779352
                                                
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                                                    Email:
                                                    
                                                
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    • 
                                                    Affiliation:
                                                    Instituto Estadual do Cérebro Paulo Niemeyer 
                                                
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Additional links:

                                                                
                            

                        

                    

                    
 

                            

        

        
 

        
    




            
    

    

        


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