Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection

IMMUNOe Research Centers40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

RuconestDRUG

C1 Esterase Inhibitor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

IMMUNOe Research Centers

Centennial, Colorado, United States

Outcomes

Primary Outcomes

Neuropsychological Measures (BRIEF-A)

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

Time frame: Week 0

Neuropsychological Measures (BRIEF-A)

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

Time frame: Week 9

Neuropsychological Measures (BRIEF-A)

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

Time frame: Week 17

Neuropsychological Measures (RBANS)

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Time frame: Week 0

Neuropsychological Measures (RBANS)

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Time frame: Week 9

Neuropsychological Measures (RBANS)

Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Time frame: Week 17

Neuropsychological Measures (BDI II)

Beck Depression Inventory II (BDI II)

Time frame: Week 0

Neuropsychological Measures (BDI II)

Beck Depression Inventory II (BDI II)

Time frame: Week 9

Neuropsychological Measures (BDI II)

Beck Depression Inventory II (BDI II)

Time frame: Week 17

Data from ClinicalTrials.gov

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