NCT04705831

Brief Summary

Randomized, Double Blind, Placebo Controlled, Proof-of-Concept Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post-SARS-CoV-2 Infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

August 11, 2025

Status Verified

January 1, 2021

Enrollment Period

3.2 years

First QC Date

January 7, 2021

Last Update Submit

August 5, 2025

Conditions

Post-Viral Fatigue SyndromePost-Viral Disorder (Disorder)Covid19

Keywords

Post-COVID SymptomsPost-Viral Fatigue Syndrome

Outcome Measures

Primary Outcomes (68)

  • Neuropsychological Measures (BRIEF-A)

    Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)

    Week 0

  • Neuropsychological Measures (BRIEF-A)

    Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)

    Week 9

  • Neuropsychological Measures (BRIEF-A)

    Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)

    Week 17

  • Neuropsychological Measures (RBANS)

    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Week 0

  • Neuropsychological Measures (RBANS)

    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Week 9

  • Neuropsychological Measures (RBANS)

    Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Week 17

  • Neuropsychological Measures (BDI II)

    Beck Depression Inventory II (BDI II)

    Week 0

  • Neuropsychological Measures (BDI II)

    Beck Depression Inventory II (BDI II)

    Week 9

  • Neuropsychological Measures (BDI II)

    Beck Depression Inventory II (BDI II)

    Week 17

  • Neuropsychological Measures (MoCA)

    Montreal Cognitive Assessment (MoCA)

    Week 0

  • Neuropsychological Measures (MoCA)

    Montreal Cognitive Assessment (MoCA)

    Week 9

  • Neuropsychological Measures (MoCA)

    Montreal Cognitive Assessment (MoCA)

    Week 17

  • Patient-Rate Questionnaires (FSS)

    Fatigue Severity Scale (FSS)

    Week 0

  • Patient-Rate Questionnaires (FSS)

    Fatigue Severity Scale (FSS)

    Week 5

  • Patient-Rate Questionnaires (FSS)

    Fatigue Severity Scale (FSS)

    Week 9

  • Patient-Rate Questionnaires (FSS)

    Fatigue Severity Scale (FSS)

    Week 14

  • Patient-Rate Questionnaires (FSS)

    Fatigue Severity Scale (FSS)

    Week 17

  • Patient-Rate Questionnaires (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Week 0

  • Patient-Rate Questionnaires (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Week 5

  • Patient-Rate Questionnaires (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Week 9

  • Patient-Rate Questionnaires (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Week 14

  • Patient-Rate Questionnaires (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Week 17

  • Patient-Rate Questionnaires (HIT)

    Headache Impact Scale (HIT)

    Week 0

  • Patient-Rate Questionnaires (HIT)

    Headache Impact Scale (HIT)

    Week 5

  • Patient-Rate Questionnaires (HIT)

    Headache Impact Scale (HIT)

    Week 9

  • Patient-Rate Questionnaires (HIT)

    Headache Impact Scale (HIT)

    Week 14

  • Patient-Rate Questionnaires (HIT)

    Headache Impact Scale (HIT)

    Week 17

  • Patient-Rate Questionnaires (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Week 0

  • Patient-Rate Questionnaires (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Week 5

  • Patient-Rate Questionnaires (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Week 9

  • Patient-Rate Questionnaires (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Week 14

  • Patient-Rate Questionnaires (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Week 17

  • Patient-Rate Questionnaires (SF)

    SF McGill Pain Questionnaire

    Week 0

  • Patient-Rate Questionnaires (SF)

    SF McGill Pain Questionnaire

    Week 5

  • Patient-Rate Questionnaires (SF)

    SF McGill Pain Questionnaire

    Week 9

  • Patient-Rate Questionnaires (SF)

    SF McGill Pain Questionnaire

    Week 14

  • Patient-Rate Questionnaires (SF)

    SF McGill Pain Questionnaire

    Week 17

  • Patient-Rate Questionnaires (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Week 0

  • Patient-Rate Questionnaires (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Week 5

  • Patient-Rate Questionnaires (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Week 9

  • Patient-Rate Questionnaires (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Week 14

  • Patient-Rate Questionnaires (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Week 17

  • Patient-Rate Questionnaires (SF-36)

    SF-36

    Week 0

  • Patient-Rate Questionnaires (SF-36)

    SF-36

    Week 5

  • Patient-Rate Questionnaires (SF-36)

    SF-36

    Week 9

  • Patient-Rate Questionnaires (SF-36)

    SF-36

    Week 14

  • Patient-Rate Questionnaires (SF-36)

    SF-36

    Week 17

  • Neurological Exam (0)

    Complete neurological examination

    Week 0

  • Neurological Exam (9)

    Complete neurological examination

    Week 9

  • Neurological Exam (17)

    Complete neurological examination

    Week 17

  • Immunological Biomarkers (Toll)

    Toll Like Receptor Function Assay

    Week 1

  • Immunological Biomarkers (Toll)

    Toll Like Receptor Function Assay

    Week 9

  • Immunological Biomarkers (Toll)

    Toll Like Receptor Function Assay

    Week 17

  • Immunological Biomarkers (GAD)

    GAD-65

    Week 1

  • Immunological Biomarkers (GAD)

    GAD-65

    Week 9

  • Immunological Biomarkers (GAD)

    GAD-65

    Week 17

  • Immunological Biomarkers (Com)

    Complement Panel (C4, C1-INH, C1-INH Function)

    Week 1

  • Immunological Biomarkers (Com)

    Complement Panel (C4, C1-INH, C1-INH Function)

    Week 9

  • Immunological Biomarkers (Com)

    Complement Panel (C4, C1-INH, C1-INH Function)

    Week 17

  • Immunological Biomarkers (Ig)

    Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)

    Week 1

  • Immunological Biomarkers (Ig)

    Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)

    Week 9

  • Immunological Biomarkers (Ig)

    Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)

    Week 17

  • Immunological Biomarkers (IgG)

    Immunoglobulins G, Subclasses (1-4)

    Week 1

  • Immunological Biomarkers (IgG)

    Immunoglobulins G, Subclasses (1-4)

    Week 9

  • Immunological Biomarkers (IgG)

    Immunoglobulins G, Subclasses (1-4)

    Week 17

  • Immunological Biomarkers (TH/TH)

    TH1/TH2 Cytokine Levels

    Week 1

  • Immunological Biomarkers (TH/TH)

    TH1/TH2 Cytokine Levels

    Week 9

  • Immunological Biomarkers (TH/TH)

    TH1/TH2 Cytokine Levels

    Week 17

Study Arms (2)

RUCONEST

ACTIVE COMPARATOR

IV Ruconest

Drug: Ruconest

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Ruconest

Interventions

RuconestDRUG

C1 Esterase Inhibitor

PlaceboRUCONEST

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and older, male or female
  • Previous confirmed diagnosis of SARS-CoV-2
  • Experiencing SARS-CoV-2 post-viral fatigue syndrome 4 weeks after recovery for SARS-CoV-2
  • Experiencing neurological symptoms including fatigue
  • Willing to comply with all aspects of the protocol, including blood draws
  • Patient is able to understand and fully participate in the activities of the study and the consent in accordance with guidelines
  • Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. Acceptable forms of contraception are defined as those with a failure rate of \< 1% when properly applied and include: a combination pill, some intra-uterine devices, and a sterilized partner in a stable relationship. Female patients must not be pregnant, planning to become pregnant, or be actively breastfeeding through the entire period.

You may not qualify if:

  • 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
  • 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 with 30 days of study entry from any other clinical study involving an investigational product
  • Patients who, in the investigator's opinion, might not be suitable for the trial for safety reasons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

Related Publications (1)

  • Melamed I, Buckley C, Bayko ME, Williams JL, Or-Geva N. Does C1 esterase inhibitor play a role in post COVID-19 neurological symptoms? A randomized, double-blind, placebo-controlled, crossover, proof-of-concept study. Front Neurol. 2025 Nov 6;16:1523814. doi: 10.3389/fneur.2025.1523814. eCollection 2025.

    PMID: 41281561DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, ChronicCOVID-19

Interventions

conestat alfa

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 12, 2021

Study Start

January 11, 2021

Primary Completion

March 30, 2024

Study Completion

July 1, 2024

Last Updated

August 11, 2025

Record last verified: 2021-01

Locations

US(1)