Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

6. November 2026 aktualisiert von: 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

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

30

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Colorado
      • Centennial, Colorado, Vereinigte Staaten, 80112
        • Rekrutierung
        • IMMUNOe Research Centers
        • Kontakt:
        • Hauptermittler:
          • Isaac Melamed, MD
        • Unterermittler:
          • J. Lynn Williams, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 90 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Ruconest

IV Ruconest

IV Ruconest

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Neuropsychological Measures (BRIEF-A)
Zeitfenster: Week 0

Behavior Rating Inventory of Executive Function - Adult

Week 0
Neuropsychological Measures (BRIEF-A)
Zeitfenster: Week 5

Behavior Rating Inventory of Executive Function - Adult

Week 5
Neuropsychological Measures (BRIEF-A)
Zeitfenster: Week 9

Behavior Rating Inventory of Executive Function - Adult

Week 9
Neuropsychological Measures (BRIEF-A)
Zeitfenster: Week 13

Behavior Rating Inventory of Executive Function - Adult

Week 13
Neuropsychological Measures (BRIEF-A)
Zeitfenster: Week 17

Behavior Rating Inventory of Executive Function - Adult

Week 17
Neuropsychological Measures (BRIEF-A)
Zeitfenster: Week 21

Behavior Rating Inventory of Executive Function - Adult

Week 21
Neuropsychological Measures (BRIEF-A)
Zeitfenster: Week 25

Behavior Rating Inventory of Executive Function - Adult

Week 25
Neuropsychological Measures (RBANS)
Zeitfenster: Week 0

Repeatable Battery for the Assessment of Neuropsychological Status

Week 0
Neuropsychological Measures (RBANS)
Zeitfenster: Week 5

Repeatable Battery for the Assessment of Neuropsychological Status

Week 5
Neuropsychological Measures (RBANS)
Zeitfenster: Week 9

Repeatable Battery for the Assessment of Neuropsychological Status

Week 9
Neuropsychological Measures (RBANS)
Zeitfenster: Week 13

Repeatable Battery for the Assessment of Neuropsychological Status

Week 13
Neuropsychological Measures (RBANS)
Zeitfenster: Week 17

Repeatable Battery for the Assessment of Neuropsychological Status

Week 17
Neuropsychological Measures (RBANS)
Zeitfenster: Week 21

Repeatable Battery for the Assessment of Neuropsychological Status

Week 21
Neuropsychological Measures (RBANS)
Zeitfenster: Week 25

Repeatable Battery for the Assessment of Neuropsychological Status

Week 25
Neuropsychological Measures (BDI II)
Zeitfenster: Week 0

Beck Depression Inventory (BDI II)

Week 0
Neuropsychological Measures (BDI II)
Zeitfenster: Week 5

Beck Depression Inventory (BDI II)

Week 5
Neuropsychological Measures (BDI II)
Zeitfenster: Week 9

Beck Depression Inventory (BDI II)

Week 9
Neuropsychological Measures (BDI II)
Zeitfenster: Week 13

Beck Depression Inventory (BDI II)

Week 13
Neuropsychological Measures (BDI II)
Zeitfenster: Week 17

Beck Depression Inventory (BDI II)

Week 17
Neuropsychological Measures (BDI II)
Zeitfenster: Week 21

Beck Depression Inventory (BDI II)

Week 21
Neuropsychological Measures (BDI II)
Zeitfenster: Week 25

Beck Depression Inventory (BDI II)

Week 25
Neuropsychological Measures (MoCA)
Zeitfenster: Week 0

Montreal Cognitive Assessment (MoCA)

Week 0
Neuropsychological Measures (MoCA)
Zeitfenster: Week 5

Montreal Cognitive Assessment (MoCA)

Week 5
Neuropsychological Measures (MoCA)
Zeitfenster: Week 9

Montreal Cognitive Assessment (MoCA)

Week 9
Neuropsychological Measures (MoCA)
Zeitfenster: Week 13

Montreal Cognitive Assessment (MoCA)

Week 13
Neuropsychological Measures (MoCA)
Zeitfenster: Week 17

Montreal Cognitive Assessment (MoCA)

Week 17
Neuropsychological Measures (MoCA)
Zeitfenster: Week 21

Montreal Cognitive Assessment (MoCA)

Week 21
Neuropsychological Measures (MoCA)
Zeitfenster: Week 25

Montreal Cognitive Assessment (MoCA)

Week 25
Patient-Rated Questionnaire (FSS)
Zeitfenster: Week 0

Fatigue Severity Scale (FSS)

Week 0
Patient-Rated Questionnaire (FSS)
Zeitfenster: Week 5

Fatigue Severity Scale (FSS)

Week 5
Patient-Rated Questionnaire (FSS)
Zeitfenster: Week 9

Fatigue Severity Scale (FSS)

Week 9
Patient-Rated Questionnaire (FSS)
Zeitfenster: Week 13

Fatigue Severity Scale (FSS)

Week 13
Patient-Rated Questionnaire (FSS)
Zeitfenster: Week 17

Fatigue Severity Scale (FSS)

Week 17
Patient-Rated Questionnaire (FSS)
Zeitfenster: Week 21

Fatigue Severity Scale (FSS)

Week 21
Patient-Rated Questionnaire (FSS)
Zeitfenster: Week 25

Fatigue Severity Scale (FSS)

Week 25
Patient-Rated Questionnaire (MIDAS)
Zeitfenster: Week 0

Migraine Disability Assessment (MIDAS)

Week 0
Patient-Rated Questionnaire (MIDAS)
Zeitfenster: Week 5

Migraine Disability Assessment (MIDAS)

Week 5
Patient-Rated Questionnaire (MIDAS)
Zeitfenster: Week 9

Migraine Disability Assessment (MIDAS)

Week 9
Patient-Rated Questionnaire (MIDAS)
Zeitfenster: Week 13

Migraine Disability Assessment (MIDAS)

Week 13
Patient-Rated Questionnaire (MIDAS)
Zeitfenster: Week 17

Migraine Disability Assessment (MIDAS)

Week 17
Patient-Rated Questionnaire (MIDAS)
Zeitfenster: Week 21

Migraine Disability Assessment (MIDAS)

Week 21
Patient-Rated Questionnaire (MIDAS)
Zeitfenster: Week 25

Migraine Disability Assessment (MIDAS)

Week 25
Patient-Rated Questionnaire (HIT)
Zeitfenster: Week 0

Headache Impact Scale (HIT)

Week 0
Patient-Rated Questionnaire (HIT)
Zeitfenster: Week 5

Headache Impact Scale (HIT)

Week 5
Patient-Rated Questionnaire (HIT)
Zeitfenster: Week 9

Headache Impact Scale (HIT)

Week 9
Patient-Rated Questionnaire (HIT)
Zeitfenster: Week 13

Headache Impact Scale (HIT)

Week 13
Patient-Rated Questionnaire (HIT)
Zeitfenster: Week 17

Headache Impact Scale (HIT)

Week 17
Patient-Rated Questionnaire (HIT)
Zeitfenster: Week 21

Headache Impact Scale (HIT)

Week 21
Patient-Rated Questionnaire (HIT)
Zeitfenster: Week 25

Headache Impact Scale (HIT)

Week 25
Patient-Rated Questionnaire (Activities)
Zeitfenster: Week 0

Activities of Daily Living Sliding Scale and Questionnaire

Week 0
Patient-Rated Questionnaire (Activities)
Zeitfenster: Week 5

Activities of Daily Living Sliding Scale and Questionnaire

Week 5
Patient-Rated Questionnaire (Activities)
Zeitfenster: Week 9

Activities of Daily Living Sliding Scale and Questionnaire

Week 9
Patient-Rated Questionnaire (Activities)
Zeitfenster: Week 13

Activities of Daily Living Sliding Scale and Questionnaire

Week 13
Patient-Rated Questionnaire (Activities)
Zeitfenster: Week 17

Activities of Daily Living Sliding Scale and Questionnaire

Week 17
Patient-Rated Questionnaire (Activities)
Zeitfenster: Week 21

Activities of Daily Living Sliding Scale and Questionnaire

Week 21
Patient-Rated Questionnaire (Activities)
Zeitfenster: Week 25

Activities of Daily Living Sliding Scale and Questionnaire

Week 25
Patient-Rated Questionnaire (SF)
Zeitfenster: Week 0

SF McGill Pain Questionnaire

Week 0
Patient-Rated Questionnaire (SF)
Zeitfenster: Week 5

SF McGill Pain Questionnaire

Week 5
Patient-Rated Questionnaire (SF)
Zeitfenster: Week 9

SF McGill Pain Questionnaire

Week 9
Patient-Rated Questionnaire (SF)
Zeitfenster: Week 13

SF McGill Pain Questionnaire

Week 13
Patient-Rated Questionnaire (SF)
Zeitfenster: Week 17

SF McGill Pain Questionnaire

Week 17
Patient-Rated Questionnaire (SF)
Zeitfenster: Week 21

SF McGill Pain Questionnaire

Week 21
Patient-Rated Questionnaire (SF)
Zeitfenster: Week 25

SF McGill Pain Questionnaire

Week 25
Patient-Rated Questionnaire (GSRS)
Zeitfenster: Week 0

Gastrointestinal Symptoms Rating Scale (GSRS)

Week 0
Patient-Rated Questionnaire (GSRS)
Zeitfenster: Week 5

Gastrointestinal Symptoms Rating Scale (GSRS)

Week 5
Patient-Rated Questionnaire (GSRS)
Zeitfenster: Week 9

Gastrointestinal Symptoms Rating Scale (GSRS)

Week 9
Patient-Rated Questionnaire (GSRS)
Zeitfenster: Week 13

Gastrointestinal Symptoms Rating Scale (GSRS)

Week 13
Patient-Rated Questionnaire (GSRS)
Zeitfenster: Week 17

Gastrointestinal Symptoms Rating Scale (GSRS)

Week 17
Patient-Rated Questionnaire (GSRS)
Zeitfenster: Week 21

Gastrointestinal Symptoms Rating Scale (GSRS)

Week 21
Patient-Rated Questionnaire (GSRS)
Zeitfenster: Week 25

Gastrointestinal Symptoms Rating Scale (GSRS)

Week 25
Patient-Rated Questionnaire (SF-36)
Zeitfenster: Week 0

SF-36

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

SF-36

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

SF-36

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

SF-36

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

SF-36

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

SF-36

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

SF-36

Week 25
Neurological Exam
Zeitfenster: Week 0

Complete neurological examination

Week 0
Neurological Exam
Zeitfenster: Week 5

Complete neurological examination

Week 5
Neurological Exam
Zeitfenster: Week 9

Complete neurological examination

Week 9
Neurological Exam
Zeitfenster: Week 13

Complete neurological examination

Week 13
Neurological Exam
Zeitfenster: Week 17

Complete neurological examination

Week 17
Neurological Exam
Zeitfenster: Week 21

Complete neurological examination

Week 21
Neurological Exam
Zeitfenster: Week 25

Complete neurological examination

Week 25

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. November 2025

Primärer Abschluss (Geschätzt)

31. Juli 2027

Studienabschluss (Geschätzt)

29. Oktober 2027

Studienanmeldedaten

Zuerst eingereicht

6. November 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. November 2026

Zuerst gepostet (Tatsächlich)

12. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • IIS202402

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .