Clinical trial NCT04705831: Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post-Viral Fatigue Syndrome
Post-Viral Disorder (Disorder)
Covid19
Keywords: Post-COVID Symptoms
Post-Viral Fatigue Syndrome
Lead sponsor: IMMUNOe Research Centers
Sponsor class: INDUSTRY
First posted: 2021-01-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neuropsychological Measures (BRIEF-A)
timeFrame: Week 0
measure: Neuropsychological Measures (BRIEF-A)
timeFrame: Week 9
measure: Neuropsychological Measures (BRIEF-A)
timeFrame: Week 17
measure: Neuropsychological Measures (RBANS)
timeFrame: Week 0
measure: Neuropsychological Measures (RBANS)
timeFrame: Week 9
measure: Neuropsychological Measures (RBANS)
timeFrame: Week 17
measure: Neuropsychological Measures (BDI II)
timeFrame: Week 0
measure: Neuropsychological Measures (BDI II)
timeFrame: Week 9
measure: Neuropsychological Measures (BDI II)
timeFrame: Week 17
measure: Neuropsychological Measures (MoCA)
timeFrame: Week 0
measure: Neuropsychological Measures (MoCA)
timeFrame: Week 9
measure: Neuropsychological Measures (MoCA)
timeFrame: Week 17
measure: Patient-Rate Questionnaires (FSS)
timeFrame: Week 0
measure: Patient-Rate Questionnaires (FSS)
timeFrame: Week 5
measure: Patient-Rate Questionnaires (FSS)
timeFrame: Week 9
measure: Patient-Rate Questionnaires (FSS)
timeFrame: Week 14
measure: Patient-Rate Questionnaires (FSS)
timeFrame: Week 17
measure: Patient-Rate Questionnaires (MIDAS)
timeFrame: Week 0
measure: Patient-Rate Questionnaires (MIDAS)
timeFrame: Week 5
measure: Patient-Rate Questionnaires (MIDAS)
timeFrame: Week 9
measure: Patient-Rate Questionnaires (MIDAS)
timeFrame: Week 14
measure: Patient-Rate Questionnaires (MIDAS)
timeFrame: Week 17
measure: Patient-Rate Questionnaires (HIT)
timeFrame: Week 0
measure: Patient-Rate Questionnaires (HIT)
timeFrame: Week 5
measure: Patient-Rate Questionnaires (HIT)
timeFrame: Week 9
measure: Patient-Rate Questionnaires (HIT)
timeFrame: Week 14
measure: Patient-Rate Questionnaires (HIT)
timeFrame: Week 17
measure: Patient-Rate Questionnaires (Activities)
timeFrame: Week 0
measure: Patient-Rate Questionnaires (Activities)
timeFrame: Week 5
measure: Patient-Rate Questionnaires (Activities)
timeFrame: Week 9
measure: Patient-Rate Questionnaires (Activities)
timeFrame: Week 14
measure: Patient-Rate Questionnaires (Activities)
timeFrame: Week 17
measure: Patient-Rate Questionnaires (SF)
timeFrame: Week 0
measure: Patient-Rate Questionnaires (SF)
timeFrame: Week 5
measure: Patient-Rate Questionnaires (SF)
timeFrame: Week 9
measure: Patient-Rate Questionnaires (SF)
timeFrame: Week 14
measure: Patient-Rate Questionnaires (SF)
timeFrame: Week 17
measure: Patient-Rate Questionnaires (GSRS)
timeFrame: Week 0
measure: Patient-Rate Questionnaires (GSRS)
timeFrame: Week 5
measure: Patient-Rate Questionnaires (GSRS)
timeFrame: Week 9
measure: Patient-Rate Questionnaires (GSRS)
timeFrame: Week 14
measure: Patient-Rate Questionnaires (GSRS)
timeFrame: Week 17
measure: Patient-Rate Questionnaires (SF-36)
timeFrame: Week 0
measure: Patient-Rate Questionnaires (SF-36)
timeFrame: Week 5
measure: Patient-Rate Questionnaires (SF-36)
timeFrame: Week 9
measure: Patient-Rate Questionnaires (SF-36)
timeFrame: Week 14
measure: Patient-Rate Questionnaires (SF-36)
timeFrame: Week 17
measure: Neurological Exam (0)
timeFrame: Week 0
measure: Neurological Exam (9)
timeFrame: Week 9
measure: Neurological Exam (17)
timeFrame: Week 17
measure: Immunological Biomarkers (Toll)
timeFrame: Week 1
measure: Immunological Biomarkers (Toll)
timeFrame: Week 9
measure: Immunological Biomarkers (Toll)
timeFrame: Week 17
measure: Immunological Biomarkers (GAD)
timeFrame: Week 1
measure: Immunological Biomarkers (GAD)
timeFrame: Week 9
measure: Immunological Biomarkers (GAD)
timeFrame: Week 17
measure: Immunological Biomarkers (Com)
timeFrame: Week 1
measure: Immunological Biomarkers (Com)
timeFrame: Week 9
measure: Immunological Biomarkers (Com)
timeFrame: Week 17
measure: Immunological Biomarkers (Ig)
timeFrame: Week 1
measure: Immunological Biomarkers (Ig)
timeFrame: Week 9
measure: Immunological Biomarkers (Ig)
timeFrame: Week 17
measure: Immunological Biomarkers (IgG)
timeFrame: Week 1
measure: Immunological Biomarkers (IgG)
timeFrame: Week 9
measure: Immunological Biomarkers (IgG)
timeFrame: Week 17
measure: Immunological Biomarkers (TH/TH)
timeFrame: Week 1
measure: Immunological Biomarkers (TH/TH)
timeFrame: Week 9
measure: Immunological Biomarkers (TH/TH)
timeFrame: Week 17
Secondary outcomes:
Other outcomes:
Locations:
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
Study officials:
References: