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

  • STATUS
    Recruiting
  • days left to enroll
    28
  • participants needed
    40
  • sponsor
    IMMUNOe Research Centers
Updated on 1 February 2021

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.

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.

Details
Condition Chronic Fatigue Syndrome, COVID19, Post-Viral Disorder (Disorder), Post-Viral Disorder (Disorder)
Treatment Ruconest
Clinical Study IdentifierNCT04705831
SponsorIMMUNOe Research Centers
Last Modified on1 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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