Covid19, Post-Viral Disorder (Disorder), Post-Viral Fatigue Syndrome
Conditions
Keywords
Post-COVID Symptoms, Post-Viral Fatigue Syndrome
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.
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.
Interventions
DRUGRuconest
C1 Esterase Inhibitor
Sponsors
IMMUNOe Research Centers
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 and older, male or female 2. Previous confirmed diagnosis of SARS-CoV-2 3. Experiencing SARS-CoV-2 post-viral fatigue syndrome 4 weeks after recovery for SARS-CoV-2 4. Experiencing neurological symptoms including fatigue 5. Willing to comply with all aspects of the protocol, including blood draws 6. Patient is able to understand and fully participate in the activities of the study and the consent in accordance with guidelines 7. 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.
Exclusion criteria
1. Receiving any form of C1-INH therapy either acute or prophylactic treatment 2. History or suspicion of allergy to rabbits 3. Neurological conditions related to injury 4. Neuropathy related to diabetes 5. Participants who are pregnant or lactating 6. Largely incapacitated or bed ridden 7. 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 8. Patients who, in the investigator's opinion, might not be suitable for the trial for safety reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychological Measures (BRIEF-A) | Week 0 | Behavior Rating Inventory of Executive Function- Adult (BRIEF-A) |
| Neuropsychological Measures (RBANS) | Week 0 | Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) |
| Neuropsychological Measures (BDI II) | Week 0 | Beck Depression Inventory II (BDI II) |
| Neuropsychological Measures (MoCA) | Week 0 | Montreal Cognitive Assessment (MoCA) |
| Patient-Rate Questionnaires (FSS) | Week 0 | Fatigue Severity Scale (FSS) |
| Patient-Rate Questionnaires (MIDAS) | Week 0 | Migraine Disability Assessment (MIDAS) |
| Patient-Rate Questionnaires (HIT) | Week 0 | Headache Impact Scale (HIT) |
| Patient-Rate Questionnaires (Activities) | Week 0 | Activities of Daily Living Sliding Scale and Questionnaire |
| Patient-Rate Questionnaires (SF) | Week 0 | SF McGill Pain Questionnaire |
| Patient-Rate Questionnaires (GSRS) | Week 0 | Gastrointestinal Symptoms Rating Scale (GSRS) |
| Patient-Rate Questionnaires (SF-36) | Week 0 | SF-36 |
| Neurological Exam (0) | Week 0 | Complete neurological examination |
| Neurological Exam (9) | Week 9 | Complete neurological examination |
| Neurological Exam (17) | Week 17 | Complete neurological examination |
| Immunological Biomarkers (Toll) | Week 1 | Toll Like Receptor Function Assay |
| Immunological Biomarkers (GAD) | Week 1 | GAD-65 |
| Immunological Biomarkers (Com) | Week 1 | Complement Panel (C4, C1-INH, C1-INH Function) |
| Immunological Biomarkers (Ig) | Week 1 | Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM) |
| Immunological Biomarkers (IgG) | Week 1 | Immunoglobulins G, Subclasses (1-4) |
| Immunological Biomarkers (TH/TH) | Week 1 | TH1/TH2 Cytokine Levels |
Countries
United States
Outcome results
None listed