Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

6. november 2026 opdateret af: 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

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Colorado
      • Centennial, Colorado, Forenede Stater, 80112
        • Rekruttering
        • IMMUNOe Research Centers
        • Kontakt:
        • Ledende efterforsker:
          • Isaac Melamed, MD
        • Underforsker:
          • J. Lynn Williams, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Ruconest

IV Ruconest
Medicin: Ruconest

IV Ruconest

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Neuropsychological Measures (BRIEF-A)
Tidsramme: Week 0

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

SF-36
Week 25
Neurological Exam
Tidsramme: Week 0

Complete neurological examination
Week 0
Neurological Exam
Tidsramme: Week 5

Complete neurological examination
Week 5
Neurological Exam
Tidsramme: Week 9

Complete neurological examination
Week 9
Neurological Exam
Tidsramme: Week 13

Complete neurological examination
Week 13
Neurological Exam
Tidsramme: Week 17

Complete neurological examination
Week 17
Neurological Exam
Tidsramme: Week 21

Complete neurological examination
Week 21
Neurological Exam
Tidsramme: Week 25

Complete neurological examination
Week 25

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

IMMUNOe Research Centers

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. november 2025

Primær færdiggørelse (Anslået)

31. juli 2027

Studieafslutning (Anslået)

29. oktober 2027

Datoer for studieregistrering

Først indsendt

6. november 2026

Først indsendt, der opfyldte QC-kriterier

6. november 2026

Først opslået (Faktiske)

12. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IIS202402

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner