Status:
COMPLETED
Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection
Lead Sponsor:
IMMUNOe Research Centers
Conditions:
Post-Viral Fatigue Syndrome
Post-Viral Disorder (Disorder)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 suc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04705831
Start Date
January 11 2021
End Date
July 1 2024
Last Update
August 11 2025
Active Locations (1)
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1
IMMUNOe Research Centers
Centennial, Colorado, United States, 80112