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

6. november 2026 oppdatert av: 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

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Colorado
      • Centennial, Colorado, Forente stater, 80112
        • Rekruttering
        • IMMUNOe Research Centers
        • Ta kontakt med:
        • Hovedetterforsker:
          • Isaac Melamed, MD
        • Underetterforsker:
          • J. Lynn Williams, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 90 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Ruconest

IV Ruconest
Legemiddel: Ruconest

IV Ruconest

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

IMMUNOe Research Centers

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. november 2025

Primær fullføring (Antatt)

31. juli 2027

Studiet fullført (Antatt)

29. oktober 2027

Datoer for studieregistrering

Først innsendt

6. november 2026

Først innsendt som oppfylte QC-kriteriene

6. november 2026

Først lagt ut (Faktiske)

12. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IIS202402

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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