NCT04705831CompletedPhase 2
Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection
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
Source: ClinicalTrials.gov · Last updated 11 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 7 Jan 2021
- Start date
- 11 Jan 2021
- Primary completion date
- 30 Mar 2024
- Lead sponsor
- IMMUNOe Research Centers
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT04705831
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 40
- From 11 Jan 2021 to the primary completion date, 30 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving any form of C1-INH therapy either acute or prophylactic treatment
- 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
Other illness
- History or suspicion of allergy to rabbits
- Neurological conditions related to injury
- Neuropathy related to diabetes
Other
- Participants who are pregnant or lactating
- Largely incapacitated or bed ridden
- Patients who, in the investigator's opinion, might not be suitable for the trial for safety reasons
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IMMUNOe Research Centers Coordinator of this site? Confirm its status | Centennial | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.