Exploring the Extended Efficacy and Initial Use of RUCONEST® in Managing Neurological Symptoms Linked to Infectious Pathogens
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
Status
Bedingungen
Bedingungen
Intervention / Behandlung
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
Studientyp
Einschreibung (Geschätzt)
Einschreibung
Phase
Phase
- Phase 4
Kontakte und Standorte
Studienorte
-
-
Colorado
-
Centennial, Colorado, Vereinigte Staaten, 80112
- Rekrutierung
- IMMUNOe Research Centers
-
Kontakt:
- Maureen Collins
- Telefonnummer: 1248 303-771-9000
- E-Mail: mcollins@immunoe.com
-
Hauptermittler:
- Isaac Melamed, MD
-
Unterermittler:
- J. Lynn Williams, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
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
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Anzahl der Arme
Waffen und Interventionen
Teilnehmergruppe / ArmTeilnehmergruppe / Arm |
Intervention / BehandlungIntervention / Behandlung |
|---|---|
|
Aktiver Komparator: Ruconest
IV Ruconest |
IV Ruconest |
Was misst die Studie?
Primäre Ergebnismessungen
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Neuropsychological Measures (BRIEF-A)
Zeitfenster: Week 0
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Behavior Rating Inventory of Executive Function - Adult |
Week 0
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Neuropsychological Measures (BRIEF-A)
Zeitfenster: Week 5
|
Behavior Rating Inventory of Executive Function - Adult |
Week 5
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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
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Neuropsychological Measures (BRIEF-A)
Zeitfenster: Week 17
|
Behavior Rating Inventory of Executive Function - Adult |
Week 17
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Neuropsychological Measures (BRIEF-A)
Zeitfenster: Week 21
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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
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Neuropsychological Measures (RBANS)
Zeitfenster: Week 5
|
Repeatable Battery for the Assessment of Neuropsychological Status |
Week 5
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Neuropsychological Measures (RBANS)
Zeitfenster: Week 9
|
Repeatable Battery for the Assessment of Neuropsychological Status |
Week 9
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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
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Neuropsychological Measures (BDI II)
Zeitfenster: Week 5
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Beck Depression Inventory (BDI II) |
Week 5
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Neuropsychological Measures (BDI II)
Zeitfenster: Week 9
|
Beck Depression Inventory (BDI II) |
Week 9
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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
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|
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
|
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Patient-Rated Questionnaire (Activities)
Zeitfenster: Week 5
|
Activities of Daily Living Sliding Scale and Questionnaire |
Week 5
|
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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
Sponsor
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Studienbeginn
Primärer Abschluss (Geschätzt)
Primärer Abschluss
Studienabschluss (Geschätzt)
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Zuerst gepostet
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes Update gepostet
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neuroinflammatorische Erkrankungen
- Erkrankungen des Bewegungsapparates
- Erkrankungen des Nervensystems
- Muskelerkrankungen
- Pathologische Prozesse
- Enzephalomyelitis
- Neuromuskuläre Erkrankungen
- Chronische Erkrankung
- Krankheitsattribute
- Infektionen der Atemwege
- Infektionen
- RNA-Virusinfektionen
- Viruserkrankungen
- Erkrankungen der Atemwege
- Lungenkrankheit
- Pneumonie, viral
- Lungenentzündung
- Coronavirus-Infektionen
- Coronaviridae-Infektionen
- Nidovirales-Infektionen
- Pathologische Zustände, Anzeichen und Symptome
- COVID-19
- Erschöpfungssyndrom, chronisch
- conestat alfa
Andere Studien-ID-Nummern
Andere Studien-ID-Nummern
- IIS202402
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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