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
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.

Unknown status
Post-Viral Fatigue Syndrome
Post-Viral Disorder (Disorder)
COVID19

Drug: Ruconest

C1 Esterase Inhibitor

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 75 Years
Countries
United States
Locations

IMMUNOe Research Centers
Centennial, Colorado, United States

Investigator: Maureen Collins
Contact: 303-771-9000
mcollins@immunoe.com

Investigator: Isaac Melamed, MD

Contacts

Maureen Collins
303-771-9000 - 1248
mcollins@immunoe.com

Alicia Palm
303-225-0087
apalm@immunoe.com

IMMUNOe Research Centers
NCT Number
Keywords
Post-COVID Symptoms
Post-Viral Fatigue Syndrome
MeSH Terms
COVID-19
Fatigue Syndrome, Chronic
Fatigue
Complement C1 Inhibitor Protein