Overview

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

Status:
Recruiting

Trial end date:
2022-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

IMMUNOe Research Centers

Treatments:

Complement C1 Inhibitor Protein

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