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Exploring the Extended Efficacy and Initial Use of RUCONEST® in Managing Neurological Symptoms Linked to Infectious Pathogens

6 de novembro de 2026 atualizado por: Isaac Melamed, MD, IMMUNOe Research Centers

Assessment of RUCONEST® (C1 Esterase Inhibitor [Recombinant]) in Alleviating Neurological Symptoms Linked to Infectious Pathogens

Assessment of RUCONEST (C1 Esterase Inhibitor [Recombinant]) in Alleviating Neurological Symptoms Linked to Infectious Pathogens

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

This study will last approximately 30 weeks including 24 infusions total, each one week apart. This is an open label extension study aimed to investigate the continued use of RUCONEST in a post-SARS-CoV-2 population who experienced neurological symptoms both in patients who have participated in the previous trial (NCT04705831) as well as RUCONEST-naive participants.

Tipo de estudo

Intervencional

Inscrição (Estimado)

30

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Colorado
      • Centennial, Colorado, Estados Unidos, 80112
        • Recrutamento
        • IMMUNOe Research Centers
        • Contato:
        • Investigador principal:
          • Isaac Melamed, MD
        • Subinvestigador:
          • J. Lynn Williams, MD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 90 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Age 18 and older, male or female
  • Patient is able to understand and fully participate in the activities of the study and the consent in accordance with federal regulations.
  • Patients who were involved in the previous study with defined post-COVID neurologic symptoms.
  • New patients who have been diagnosed with post-COVID neurologic symptoms.

Exclusion Criteria:

  • Receiving any form of C1-INH therapy, either acute or prophylactic treatment
  • History or suspicion of allergy to rabbits
  • Neurological conditions related to injury
  • Neuropathy related to diabetes
  • Abnormal kidney or liver enzymes
  • History of thrombotic stroke
  • Participants who are pregnant or lactating
  • Largely incapacitated or bed-ridden
  • Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study or have discontinued within 30 days of study entry from any other clinical study involving and investigational product.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Ruconest

IV Ruconest
Medicamento: Ruconest

IV Ruconest

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Neuropsychological Measures (BRIEF-A)
Prazo: Week 0

Behavior Rating Inventory of Executive Function - Adult
Week 0
Neuropsychological Measures (BRIEF-A)
Prazo: Week 5

Behavior Rating Inventory of Executive Function - Adult
Week 5
Neuropsychological Measures (BRIEF-A)
Prazo: Week 9

Behavior Rating Inventory of Executive Function - Adult
Week 9
Neuropsychological Measures (BRIEF-A)
Prazo: Week 13

Behavior Rating Inventory of Executive Function - Adult
Week 13
Neuropsychological Measures (BRIEF-A)
Prazo: Week 17

Behavior Rating Inventory of Executive Function - Adult
Week 17
Neuropsychological Measures (BRIEF-A)
Prazo: Week 21

Behavior Rating Inventory of Executive Function - Adult
Week 21
Neuropsychological Measures (BRIEF-A)
Prazo: Week 25

Behavior Rating Inventory of Executive Function - Adult
Week 25
Neuropsychological Measures (RBANS)
Prazo: Week 0

Repeatable Battery for the Assessment of Neuropsychological Status
Week 0
Neuropsychological Measures (RBANS)
Prazo: Week 5

Repeatable Battery for the Assessment of Neuropsychological Status
Week 5
Neuropsychological Measures (RBANS)
Prazo: Week 9

Repeatable Battery for the Assessment of Neuropsychological Status
Week 9
Neuropsychological Measures (RBANS)
Prazo: Week 13

Repeatable Battery for the Assessment of Neuropsychological Status
Week 13
Neuropsychological Measures (RBANS)
Prazo: Week 17

Repeatable Battery for the Assessment of Neuropsychological Status
Week 17
Neuropsychological Measures (RBANS)
Prazo: Week 21

Repeatable Battery for the Assessment of Neuropsychological Status
Week 21
Neuropsychological Measures (RBANS)
Prazo: Week 25

Repeatable Battery for the Assessment of Neuropsychological Status
Week 25
Neuropsychological Measures (BDI II)
Prazo: Week 0

Beck Depression Inventory (BDI II)
Week 0
Neuropsychological Measures (BDI II)
Prazo: Week 5

Beck Depression Inventory (BDI II)
Week 5
Neuropsychological Measures (BDI II)
Prazo: Week 9

Beck Depression Inventory (BDI II)
Week 9
Neuropsychological Measures (BDI II)
Prazo: Week 13

Beck Depression Inventory (BDI II)
Week 13
Neuropsychological Measures (BDI II)
Prazo: Week 17

Beck Depression Inventory (BDI II)
Week 17
Neuropsychological Measures (BDI II)
Prazo: Week 21

Beck Depression Inventory (BDI II)
Week 21
Neuropsychological Measures (BDI II)
Prazo: Week 25

Beck Depression Inventory (BDI II)
Week 25
Neuropsychological Measures (MoCA)
Prazo: Week 0

Montreal Cognitive Assessment (MoCA)
Week 0
Neuropsychological Measures (MoCA)
Prazo: Week 5

Montreal Cognitive Assessment (MoCA)
Week 5
Neuropsychological Measures (MoCA)
Prazo: Week 9

Montreal Cognitive Assessment (MoCA)
Week 9
Neuropsychological Measures (MoCA)
Prazo: Week 13

Montreal Cognitive Assessment (MoCA)
Week 13
Neuropsychological Measures (MoCA)
Prazo: Week 17

Montreal Cognitive Assessment (MoCA)
Week 17
Neuropsychological Measures (MoCA)
Prazo: Week 21

Montreal Cognitive Assessment (MoCA)
Week 21
Neuropsychological Measures (MoCA)
Prazo: Week 25

Montreal Cognitive Assessment (MoCA)
Week 25
Patient-Rated Questionnaire (FSS)
Prazo: Week 0

Fatigue Severity Scale (FSS)
Week 0
Patient-Rated Questionnaire (FSS)
Prazo: Week 5

Fatigue Severity Scale (FSS)
Week 5
Patient-Rated Questionnaire (FSS)
Prazo: Week 9

Fatigue Severity Scale (FSS)
Week 9
Patient-Rated Questionnaire (FSS)
Prazo: Week 13

Fatigue Severity Scale (FSS)
Week 13
Patient-Rated Questionnaire (FSS)
Prazo: Week 17

Fatigue Severity Scale (FSS)
Week 17
Patient-Rated Questionnaire (FSS)
Prazo: Week 21

Fatigue Severity Scale (FSS)
Week 21
Patient-Rated Questionnaire (FSS)
Prazo: Week 25

Fatigue Severity Scale (FSS)
Week 25
Patient-Rated Questionnaire (MIDAS)
Prazo: Week 0

Migraine Disability Assessment (MIDAS)
Week 0
Patient-Rated Questionnaire (MIDAS)
Prazo: Week 5

Migraine Disability Assessment (MIDAS)
Week 5
Patient-Rated Questionnaire (MIDAS)
Prazo: Week 9

Migraine Disability Assessment (MIDAS)
Week 9
Patient-Rated Questionnaire (MIDAS)
Prazo: Week 13

Migraine Disability Assessment (MIDAS)
Week 13
Patient-Rated Questionnaire (MIDAS)
Prazo: Week 17

Migraine Disability Assessment (MIDAS)
Week 17
Patient-Rated Questionnaire (MIDAS)
Prazo: Week 21

Migraine Disability Assessment (MIDAS)
Week 21
Patient-Rated Questionnaire (MIDAS)
Prazo: Week 25

Migraine Disability Assessment (MIDAS)
Week 25
Patient-Rated Questionnaire (HIT)
Prazo: Week 0

Headache Impact Scale (HIT)
Week 0
Patient-Rated Questionnaire (HIT)
Prazo: Week 5

Headache Impact Scale (HIT)
Week 5
Patient-Rated Questionnaire (HIT)
Prazo: Week 9

Headache Impact Scale (HIT)
Week 9
Patient-Rated Questionnaire (HIT)
Prazo: Week 13

Headache Impact Scale (HIT)
Week 13
Patient-Rated Questionnaire (HIT)
Prazo: Week 17

Headache Impact Scale (HIT)
Week 17
Patient-Rated Questionnaire (HIT)
Prazo: Week 21

Headache Impact Scale (HIT)
Week 21
Patient-Rated Questionnaire (HIT)
Prazo: Week 25

Headache Impact Scale (HIT)
Week 25
Patient-Rated Questionnaire (Activities)
Prazo: Week 0

Activities of Daily Living Sliding Scale and Questionnaire
Week 0
Patient-Rated Questionnaire (Activities)
Prazo: Week 5

Activities of Daily Living Sliding Scale and Questionnaire
Week 5
Patient-Rated Questionnaire (Activities)
Prazo: Week 9

Activities of Daily Living Sliding Scale and Questionnaire
Week 9
Patient-Rated Questionnaire (Activities)
Prazo: Week 13

Activities of Daily Living Sliding Scale and Questionnaire
Week 13
Patient-Rated Questionnaire (Activities)
Prazo: Week 17

Activities of Daily Living Sliding Scale and Questionnaire
Week 17
Patient-Rated Questionnaire (Activities)
Prazo: Week 21

Activities of Daily Living Sliding Scale and Questionnaire
Week 21
Patient-Rated Questionnaire (Activities)
Prazo: Week 25

Activities of Daily Living Sliding Scale and Questionnaire
Week 25
Patient-Rated Questionnaire (SF)
Prazo: Week 0

SF McGill Pain Questionnaire
Week 0
Patient-Rated Questionnaire (SF)
Prazo: Week 5

SF McGill Pain Questionnaire
Week 5
Patient-Rated Questionnaire (SF)
Prazo: Week 9

SF McGill Pain Questionnaire
Week 9
Patient-Rated Questionnaire (SF)
Prazo: Week 13

SF McGill Pain Questionnaire
Week 13
Patient-Rated Questionnaire (SF)
Prazo: Week 17

SF McGill Pain Questionnaire
Week 17
Patient-Rated Questionnaire (SF)
Prazo: Week 21

SF McGill Pain Questionnaire
Week 21
Patient-Rated Questionnaire (SF)
Prazo: Week 25

SF McGill Pain Questionnaire
Week 25
Patient-Rated Questionnaire (GSRS)
Prazo: Week 0

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 0
Patient-Rated Questionnaire (GSRS)
Prazo: Week 5

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 5
Patient-Rated Questionnaire (GSRS)
Prazo: Week 9

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 9
Patient-Rated Questionnaire (GSRS)
Prazo: Week 13

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 13
Patient-Rated Questionnaire (GSRS)
Prazo: Week 17

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 17
Patient-Rated Questionnaire (GSRS)
Prazo: Week 21

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 21
Patient-Rated Questionnaire (GSRS)
Prazo: Week 25

Gastrointestinal Symptoms Rating Scale (GSRS)
Week 25
Patient-Rated Questionnaire (SF-36)
Prazo: Week 0

SF-36
Week 0
Patient-Rated Questionnaire (SF-36)
Prazo: Week 5

SF-36
Week 5
Patient-Rated Questionnaire (SF-36)
Prazo: Week 9

SF-36
Week 9
Patient-Rated Questionnaire (SF-36)
Prazo: Week 13

SF-36
Week 13
Patient-Rated Questionnaire (SF-36)
Prazo: Week 17

SF-36
Week 17
Patient-Rated Questionnaire (SF-36)
Prazo: Week 21

SF-36
Week 21
Patient-Rated Questionnaire (SF-36)
Prazo: Week 25

SF-36
Week 25
Neurological Exam
Prazo: Week 0

Complete neurological examination
Week 0
Neurological Exam
Prazo: Week 5

Complete neurological examination
Week 5
Neurological Exam
Prazo: Week 9

Complete neurological examination
Week 9
Neurological Exam
Prazo: Week 13

Complete neurological examination
Week 13
Neurological Exam
Prazo: Week 17

Complete neurological examination
Week 17
Neurological Exam
Prazo: Week 21

Complete neurological examination
Week 21
Neurological Exam
Prazo: Week 25

Complete neurological examination
Week 25

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

IMMUNOe Research Centers

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de novembro de 2025

Conclusão Primária (Estimado)

31 de julho de 2027

Conclusão do estudo (Estimado)

29 de outubro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

6 de novembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de novembro de 2026

Primeira postagem (Real)

12 de novembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IIS202402

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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