Post-Viral Fatigue SyndromePhase 2NCT04705831
Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection
A Phase 2 study testing Ruconest in people with Post-Viral Fatigue Syndrome and Post-Viral Disorder (Disorder), run by IMMUNOe Research Centers at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Viral Fatigue Syndrome, Post-Viral Disorder (Disorder), Covid19
- What is being tested?
- Ruconest
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 1 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
IMMUNOe Research Centers
Centennial, Colorado, 80112
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Cross-Over, Proof-of-Concept Study to Evaluate the Benefit of RUCONEST (C1 Esterase Inhibitor [Recombinant]) in Improving Neurological Symptoms in Post-SARS-CoV-2 Infection
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.
Read the detailed description
This study will last approximately 19 weeks including 16 infusions total, each one week apart. This is to help patients that have developed "Post-Viral Fatigue Syndrome" which can include symptoms such as: extreme fatigue, lost of taste, brain fog, and/or seizures.
- Being tested
- Ruconest
- Keywords
- Post-COVID Symptoms, Post-Viral Fatigue Syndrome
- Medical subject headings
- Fatigue Syndrome, Chronic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuconestDrug
C1 Esterase Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| RUCONEST | Active comparator | IV Ruconest Receives: Drug: Ruconest |
| Placebo | Placebo comparator | Placebo Receives: Drug: Ruconest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Measures (BRIEF-A)
Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
Measured: Week 0
Neuropsychological Measures (BRIEF-A)
Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
Measured: Week 9
Neuropsychological Measures (BRIEF-A)
Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
Measured: Week 17
Neuropsychological Measures (RBANS)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: Week 0
Neuropsychological Measures (RBANS)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: Week 9
Neuropsychological Measures (RBANS)
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: Week 17
Neuropsychological Measures (BDI II)
Beck Depression Inventory II (BDI II)
Measured: Week 0
Neuropsychological Measures (BDI II)
Beck Depression Inventory II (BDI II)
Measured: Week 9
Neuropsychological Measures (BDI II)
Beck Depression Inventory II (BDI II)
Measured: Week 17
Neuropsychological Measures (MoCA)
Montreal Cognitive Assessment (MoCA)
Measured: Week 0
Neuropsychological Measures (MoCA)
Montreal Cognitive Assessment (MoCA)
Measured: Week 9
Neuropsychological Measures (MoCA)
Montreal Cognitive Assessment (MoCA)
Measured: Week 17
Patient-Rate Questionnaires (FSS)
Fatigue Severity Scale (FSS)
Measured: Week 0
Patient-Rate Questionnaires (FSS)
Fatigue Severity Scale (FSS)
Measured: Week 5
Patient-Rate Questionnaires (FSS)
Fatigue Severity Scale (FSS)
Measured: Week 9
Patient-Rate Questionnaires (FSS)
Fatigue Severity Scale (FSS)
Measured: Week 14
Patient-Rate Questionnaires (FSS)
Fatigue Severity Scale (FSS)
Measured: Week 17
Patient-Rate Questionnaires (MIDAS)
Migraine Disability Assessment (MIDAS)
Measured: Week 0
Patient-Rate Questionnaires (MIDAS)
Migraine Disability Assessment (MIDAS)
Measured: Week 5
Patient-Rate Questionnaires (MIDAS)
Migraine Disability Assessment (MIDAS)
Measured: Week 9
Patient-Rate Questionnaires (MIDAS)
Migraine Disability Assessment (MIDAS)
Measured: Week 14
Patient-Rate Questionnaires (MIDAS)
Migraine Disability Assessment (MIDAS)
Measured: Week 17
Patient-Rate Questionnaires (HIT)
Headache Impact Scale (HIT)
Measured: Week 0
Patient-Rate Questionnaires (HIT)
Headache Impact Scale (HIT)
Measured: Week 5
Patient-Rate Questionnaires (HIT)
Headache Impact Scale (HIT)
Measured: Week 9
Patient-Rate Questionnaires (HIT)
Headache Impact Scale (HIT)
Measured: Week 14
Patient-Rate Questionnaires (HIT)
Headache Impact Scale (HIT)
Measured: Week 17
Patient-Rate Questionnaires (Activities)
Activities of Daily Living Sliding Scale and Questionnaire
Measured: Week 0
Patient-Rate Questionnaires (Activities)
Activities of Daily Living Sliding Scale and Questionnaire
Measured: Week 5
Patient-Rate Questionnaires (Activities)
Activities of Daily Living Sliding Scale and Questionnaire
Measured: Week 9
Patient-Rate Questionnaires (Activities)
Activities of Daily Living Sliding Scale and Questionnaire
Measured: Week 14
Patient-Rate Questionnaires (Activities)
Activities of Daily Living Sliding Scale and Questionnaire
Measured: Week 17
Patient-Rate Questionnaires (SF)
SF McGill Pain Questionnaire
Measured: Week 0
Patient-Rate Questionnaires (SF)
SF McGill Pain Questionnaire
Measured: Week 5
Patient-Rate Questionnaires (SF)
SF McGill Pain Questionnaire
Measured: Week 9
Patient-Rate Questionnaires (SF)
SF McGill Pain Questionnaire
Measured: Week 14
Patient-Rate Questionnaires (SF)
SF McGill Pain Questionnaire
Measured: Week 17
Patient-Rate Questionnaires (GSRS)
Gastrointestinal Symptoms Rating Scale (GSRS)
Measured: Week 0
Patient-Rate Questionnaires (GSRS)
Gastrointestinal Symptoms Rating Scale (GSRS)
Measured: Week 5
Patient-Rate Questionnaires (GSRS)
Gastrointestinal Symptoms Rating Scale (GSRS)
Measured: Week 9
Patient-Rate Questionnaires (GSRS)
Gastrointestinal Symptoms Rating Scale (GSRS)
Measured: Week 14
Patient-Rate Questionnaires (GSRS)
Gastrointestinal Symptoms Rating Scale (GSRS)
Measured: Week 17
Patient-Rate Questionnaires (SF-36)
SF-36
Measured: Week 0
Patient-Rate Questionnaires (SF-36)
SF-36
Measured: Week 5
Patient-Rate Questionnaires (SF-36)
SF-36
Measured: Week 9
Patient-Rate Questionnaires (SF-36)
SF-36
Measured: Week 14
Patient-Rate Questionnaires (SF-36)
SF-36
Measured: Week 17
Neurological Exam (0)
Complete neurological examination
Measured: Week 0
Neurological Exam (9)
Complete neurological examination
Measured: Week 9
Neurological Exam (17)
Complete neurological examination
Measured: Week 17
Immunological Biomarkers (Toll)
Toll Like Receptor Function Assay
Measured: Week 1
Immunological Biomarkers (Toll)
Toll Like Receptor Function Assay
Measured: Week 9
Immunological Biomarkers (Toll)
Toll Like Receptor Function Assay
Measured: Week 17
Immunological Biomarkers (GAD)
GAD-65
Measured: Week 1
Immunological Biomarkers (GAD)
GAD-65
Measured: Week 9
Immunological Biomarkers (GAD)
GAD-65
Measured: Week 17
Immunological Biomarkers (Com)
Complement Panel (C4, C1-INH, C1-INH Function)
Measured: Week 1
Immunological Biomarkers (Com)
Complement Panel (C4, C1-INH, C1-INH Function)
Measured: Week 9
Immunological Biomarkers (Com)
Complement Panel (C4, C1-INH, C1-INH Function)
Measured: Week 17
Immunological Biomarkers (Ig)
Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
Measured: Week 1
Immunological Biomarkers (Ig)
Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
Measured: Week 9
Immunological Biomarkers (Ig)
Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
Measured: Week 17
Immunological Biomarkers (IgG)
Immunoglobulins G, Subclasses (1-4)
Measured: Week 1
Immunological Biomarkers (IgG)
Immunoglobulins G, Subclasses (1-4)
Measured: Week 9
Immunological Biomarkers (IgG)
Immunoglobulins G, Subclasses (1-4)
Measured: Week 17
Immunological Biomarkers (TH/TH)
TH1/TH2 Cytokine Levels
Measured: Week 1
Immunological Biomarkers (TH/TH)
TH1/TH2 Cytokine Levels
Measured: Week 9
Immunological Biomarkers (TH/TH)
TH1/TH2 Cytokine Levels
Measured: Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start11 Jan 2021
- Primary completion30 Mar 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Viral Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IMMUNOe Research Centers
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Isaac Melamed, MD, IMMUNOe Research Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705831
- Sponsor's protocol ID
- IIS202001-Neuroimmune
- Status last verified
- Jan 2021
- First submitted
- 7 Jan 2021
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41281561
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Cross-Over, Proof-of-Concept Study to Evaluate the Benefit of RUCONEST (C1 Esterase Inhibitor [Recombinant]) in Improving Neurological Symptoms in Post-SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04705831
- Acronym / sponsor ID
- IIS202001-Neuroimmune
- Keywords
- Post-COVID Symptoms, Post-Viral Fatigue Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IMMUNOe Research CentersIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will last approximately 19 weeks including 16 infusions total, each one week apart. This is to help patients that have developed "Post-Viral Fatigue Syndrome" which can include symptoms such as: extreme fatigue, lost of taste, brain fog, and/or seizures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RUCONEST | Active comparator | Drug: RuconestIV Ruconest |
| Placebo | Placebo comparator | Drug: RuconestPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuconestC1 Esterase Inhibitor | Drug | Placebo, RUCONEST |
Primary outcome
Neuropsychological Measures (BRIEF-A)
Time frame: Week 0
Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
Neuropsychological Measures (BRIEF-A)
Time frame: Week 9
Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
Neuropsychological Measures (BRIEF-A)
Time frame: Week 17
Behavior Rating Inventory of Executive Function- Adult (BRIEF-A)
Neuropsychological Measures (RBANS)
Time frame: Week 0
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Neuropsychological Measures (RBANS)
Time frame: Week 9
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Neuropsychological Measures (RBANS)
Time frame: Week 17
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Neuropsychological Measures (BDI II)
Time frame: Week 0
Beck Depression Inventory II (BDI II)
Neuropsychological Measures (BDI II)
Time frame: Week 9
Beck Depression Inventory II (BDI II)
Neuropsychological Measures (BDI II)
Time frame: Week 17
Beck Depression Inventory II (BDI II)
Neuropsychological Measures (MoCA)
Time frame: Week 0
Montreal Cognitive Assessment (MoCA)
Neuropsychological Measures (MoCA)
Time frame: Week 9
Montreal Cognitive Assessment (MoCA)
Neuropsychological Measures (MoCA)
Time frame: Week 17
Montreal Cognitive Assessment (MoCA)
Patient-Rate Questionnaires (FSS)
Time frame: Week 0
Fatigue Severity Scale (FSS)
Patient-Rate Questionnaires (FSS)
Time frame: Week 5
Fatigue Severity Scale (FSS)
Patient-Rate Questionnaires (FSS)
Time frame: Week 9
Fatigue Severity Scale (FSS)
Patient-Rate Questionnaires (FSS)
Time frame: Week 14
Fatigue Severity Scale (FSS)
Patient-Rate Questionnaires (FSS)
Time frame: Week 17
Fatigue Severity Scale (FSS)
Patient-Rate Questionnaires (MIDAS)
Time frame: Week 0
Migraine Disability Assessment (MIDAS)
Patient-Rate Questionnaires (MIDAS)
Time frame: Week 5
Migraine Disability Assessment (MIDAS)
Patient-Rate Questionnaires (MIDAS)
Time frame: Week 9
Migraine Disability Assessment (MIDAS)
Patient-Rate Questionnaires (MIDAS)
Time frame: Week 14
Migraine Disability Assessment (MIDAS)
Patient-Rate Questionnaires (MIDAS)
Time frame: Week 17
Migraine Disability Assessment (MIDAS)
Patient-Rate Questionnaires (HIT)
Time frame: Week 0
Headache Impact Scale (HIT)
Patient-Rate Questionnaires (HIT)
Time frame: Week 5
Headache Impact Scale (HIT)
Patient-Rate Questionnaires (HIT)
Time frame: Week 9
Headache Impact Scale (HIT)
Patient-Rate Questionnaires (HIT)
Time frame: Week 14
Headache Impact Scale (HIT)
Patient-Rate Questionnaires (HIT)
Time frame: Week 17
Headache Impact Scale (HIT)
Patient-Rate Questionnaires (Activities)
Time frame: Week 0
Activities of Daily Living Sliding Scale and Questionnaire
Patient-Rate Questionnaires (Activities)
Time frame: Week 5
Activities of Daily Living Sliding Scale and Questionnaire
Patient-Rate Questionnaires (Activities)
Time frame: Week 9
Activities of Daily Living Sliding Scale and Questionnaire
Patient-Rate Questionnaires (Activities)
Time frame: Week 14
Activities of Daily Living Sliding Scale and Questionnaire
Patient-Rate Questionnaires (Activities)
Time frame: Week 17
Activities of Daily Living Sliding Scale and Questionnaire
Patient-Rate Questionnaires (SF)
Time frame: Week 0
SF McGill Pain Questionnaire
Patient-Rate Questionnaires (SF)
Time frame: Week 5
SF McGill Pain Questionnaire
Patient-Rate Questionnaires (SF)
Time frame: Week 9
SF McGill Pain Questionnaire
Patient-Rate Questionnaires (SF)
Time frame: Week 14
SF McGill Pain Questionnaire
Patient-Rate Questionnaires (SF)
Time frame: Week 17
SF McGill Pain Questionnaire
Patient-Rate Questionnaires (GSRS)
Time frame: Week 0
Gastrointestinal Symptoms Rating Scale (GSRS)
Patient-Rate Questionnaires (GSRS)
Time frame: Week 5
Gastrointestinal Symptoms Rating Scale (GSRS)
Patient-Rate Questionnaires (GSRS)
Time frame: Week 9
Gastrointestinal Symptoms Rating Scale (GSRS)
Patient-Rate Questionnaires (GSRS)
Time frame: Week 14
Gastrointestinal Symptoms Rating Scale (GSRS)
Patient-Rate Questionnaires (GSRS)
Time frame: Week 17
Gastrointestinal Symptoms Rating Scale (GSRS)
Patient-Rate Questionnaires (SF-36)
Time frame: Week 0
SF-36
Patient-Rate Questionnaires (SF-36)
Time frame: Week 5
SF-36
Patient-Rate Questionnaires (SF-36)
Time frame: Week 9
SF-36
Patient-Rate Questionnaires (SF-36)
Time frame: Week 14
SF-36
Patient-Rate Questionnaires (SF-36)
Time frame: Week 17
SF-36
Neurological Exam (0)
Time frame: Week 0
Complete neurological examination
Neurological Exam (9)
Time frame: Week 9
Complete neurological examination
Neurological Exam (17)
Time frame: Week 17
Complete neurological examination
Immunological Biomarkers (Toll)
Time frame: Week 1
Toll Like Receptor Function Assay
Immunological Biomarkers (Toll)
Time frame: Week 9
Toll Like Receptor Function Assay
Immunological Biomarkers (Toll)
Time frame: Week 17
Toll Like Receptor Function Assay
Immunological Biomarkers (GAD)
Time frame: Week 1
GAD-65
Immunological Biomarkers (GAD)
Time frame: Week 9
GAD-65
Immunological Biomarkers (GAD)
Time frame: Week 17
GAD-65
Immunological Biomarkers (Com)
Time frame: Week 1
Complement Panel (C4, C1-INH, C1-INH Function)
Immunological Biomarkers (Com)
Time frame: Week 9
Complement Panel (C4, C1-INH, C1-INH Function)
Immunological Biomarkers (Com)
Time frame: Week 17
Complement Panel (C4, C1-INH, C1-INH Function)
Immunological Biomarkers (Ig)
Time frame: Week 1
Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
Immunological Biomarkers (Ig)
Time frame: Week 9
Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
Immunological Biomarkers (Ig)
Time frame: Week 17
Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM)
Immunological Biomarkers (IgG)
Time frame: Week 1
Immunoglobulins G, Subclasses (1-4)
Immunological Biomarkers (IgG)
Time frame: Week 9
Immunoglobulins G, Subclasses (1-4)
Immunological Biomarkers (IgG)
Time frame: Week 17
Immunoglobulins G, Subclasses (1-4)
Immunological Biomarkers (TH/TH)
Time frame: Week 1
TH1/TH2 Cytokine Levels
Immunological Biomarkers (TH/TH)
Time frame: Week 9
TH1/TH2 Cytokine Levels
Immunological Biomarkers (TH/TH)
Time frame: Week 17
TH1/TH2 Cytokine Levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Derived from this study: PubMed 41281561Melamed 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruconest in people with Post-Viral Fatigue Syndrome and Post-Viral Disorder (Disorder), run by IMMUNOe Research Centers at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological Measures (BRIEF-A) (time frame: Week 0). The study lists 68 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04705831, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.