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

IMMUNOe Research Centers

Status and phase: Unknown; Phase 4

Conditions: Post-Viral Fatigue Syndrome; Post-Viral Disorder (Disorder); Covid19

Treatments: Drug: Ruconest

Study type: Interventional

Funder types: Industry

Identifiers

NCT04705831

IIS202001-Neuroimmune

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

RUCONEST

Active Comparator group

Description:

IV Ruconest

Treatment:

Drug: Ruconest

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Ruconest