Recruiting
Phase 4

RUCONEST

Sponsor:

IMMUNOe Research Centers

Code:

NCT07932002

Conditions

Post SARS-CoV2 (COVID-19)

Post-Viral Fatigue Syndrome

Post-Viral Disorder (Disorder)

COVID - 19

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ruconest

Study Details

Brief summary:

Assessment of RUCONEST (C1 Esterase Inhibitor \[Recombinant\]) in Alleviating Neurological Symptoms Linked to Infectious Pathogens

Conditions

Post SARS-CoV2 (COVID-19)

Post-Viral Fatigue Syndrome

Post-Viral Disorder (Disorder)

COVID - 19

Study ID

NCT07932002

Start date

Nov 5, 2025

Status verified date

Nov, 2026

Completion date

Oct 29, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 and older, male or female
  • Patient is able to understand and fully participate in the activities of the study and the consent in accordance with federal regulations.
  • Patients who were involved in the previous study with defined post-COVID neurologic symptoms.
  • New patients who have been diagnosed with post-COVID neurologic symptoms.

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
  • Abnormal kidney or liver enzymes
  • History of thrombotic stroke
  • 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 within 30 days of study entry from any other clinical study involving and investigational product.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Ruconest

IV Ruconest

Interventions

Ruconest

IV Ruconest

Primary outcome measure

  • Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 0 ]
  • Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 5 ]
  • Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 9 ]
  • Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 13 ]
  • Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 17 ]
  • Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 21 ]
  • Neuropsychological Measures (BRIEF-A) [ Time Frame: Week 25 ]
  • Neuropsychological Measures (RBANS) [ Time Frame: Week 0 ]
  • Neuropsychological Measures (RBANS) [ Time Frame: Week 5 ]
  • Neuropsychological Measures (RBANS) [ Time Frame: Week 9 ]
  • Neuropsychological Measures (RBANS) [ Time Frame: Week 13 ]
  • Neuropsychological Measures (RBANS) [ Time Frame: Week 17 ]
  • Neuropsychological Measures (RBANS) [ Time Frame: Week 21 ]
  • Neuropsychological Measures (RBANS) [ Time Frame: Week 25 ]
  • Neuropsychological Measures (BDI II) [ Time Frame: Week 0 ]
  • Neuropsychological Measures (BDI II) [ Time Frame: Week 5 ]
  • Neuropsychological Measures (BDI II) [ Time Frame: Week 9 ]
  • Neuropsychological Measures (BDI II) [ Time Frame: Week 13 ]
  • Neuropsychological Measures (BDI II) [ Time Frame: Week 17 ]
  • Neuropsychological Measures (BDI II) [ Time Frame: Week 21 ]
  • Neuropsychological Measures (BDI II) [ Time Frame: Week 25 ]
  • Neuropsychological Measures (MoCA) [ Time Frame: Week 0 ]
  • Neuropsychological Measures (MoCA) [ Time Frame: Week 5 ]
  • Neuropsychological Measures (MoCA) [ Time Frame: Week 9 ]
  • Neuropsychological Measures (MoCA) [ Time Frame: Week 13 ]
  • Neuropsychological Measures (MoCA) [ Time Frame: Week 17 ]
  • Neuropsychological Measures (MoCA) [ Time Frame: Week 21 ]
  • Neuropsychological Measures (MoCA) [ Time Frame: Week 25 ]
  • Patient-Rated Questionnaire (FSS) [ Time Frame: Week 0 ]
  • Patient-Rated Questionnaire (FSS) [ Time Frame: Week 5 ]
  • Patient-Rated Questionnaire (FSS) [ Time Frame: Week 9 ]
  • Patient-Rated Questionnaire (FSS) [ Time Frame: Week 13 ]
  • Patient-Rated Questionnaire (FSS) [ Time Frame: Week 17 ]
  • Patient-Rated Questionnaire (FSS) [ Time Frame: Week 21 ]
  • Patient-Rated Questionnaire (FSS) [ Time Frame: Week 25 ]
  • Patient-Rated Questionnaire (MIDAS) [ Time Frame: Week 0 ]
  • Patient-Rated Questionnaire (MIDAS) [ Time Frame: Week 5 ]
  • Patient-Rated Questionnaire (MIDAS) [ Time Frame: Week 9 ]
  • Patient-Rated Questionnaire (MIDAS) [ Time Frame: Week 13 ]
  • Patient-Rated Questionnaire (MIDAS) [ Time Frame: Week 17 ]
  • Patient-Rated Questionnaire (MIDAS) [ Time Frame: Week 21 ]
  • Patient-Rated Questionnaire (MIDAS) [ Time Frame: Week 25 ]
  • Patient-Rated Questionnaire (HIT) [ Time Frame: Week 0 ]
  • Patient-Rated Questionnaire (HIT) [ Time Frame: Week 5 ]
  • Patient-Rated Questionnaire (HIT) [ Time Frame: Week 9 ]
  • Patient-Rated Questionnaire (HIT) [ Time Frame: Week 13 ]
  • Patient-Rated Questionnaire (HIT) [ Time Frame: Week 17 ]
  • Patient-Rated Questionnaire (HIT) [ Time Frame: Week 21 ]
  • Patient-Rated Questionnaire (HIT) [ Time Frame: Week 25 ]
  • Patient-Rated Questionnaire (Activities) [ Time Frame: Week 0 ]
  • Patient-Rated Questionnaire (Activities) [ Time Frame: Week 5 ]
  • Patient-Rated Questionnaire (Activities) [ Time Frame: Week 9 ]
  • Patient-Rated Questionnaire (Activities) [ Time Frame: Week 13 ]
  • Patient-Rated Questionnaire (Activities) [ Time Frame: Week 17 ]
  • Patient-Rated Questionnaire (Activities) [ Time Frame: Week 21 ]
  • Patient-Rated Questionnaire (Activities) [ Time Frame: Week 25 ]
  • Patient-Rated Questionnaire (SF) [ Time Frame: Week 0 ]
  • Patient-Rated Questionnaire (SF) [ Time Frame: Week 5 ]
  • Patient-Rated Questionnaire (SF) [ Time Frame: Week 9 ]
  • Patient-Rated Questionnaire (SF) [ Time Frame: Week 13 ]
  • Patient-Rated Questionnaire (SF) [ Time Frame: Week 17 ]
  • Patient-Rated Questionnaire (SF) [ Time Frame: Week 21 ]
  • Patient-Rated Questionnaire (SF) [ Time Frame: Week 25 ]
  • Patient-Rated Questionnaire (GSRS) [ Time Frame: Week 0 ]
  • Patient-Rated Questionnaire (GSRS) [ Time Frame: Week 5 ]
  • Patient-Rated Questionnaire (GSRS) [ Time Frame: Week 9 ]
  • Patient-Rated Questionnaire (GSRS) [ Time Frame: Week 13 ]
  • Patient-Rated Questionnaire (GSRS) [ Time Frame: Week 17 ]
  • Patient-Rated Questionnaire (GSRS) [ Time Frame: Week 21 ]
  • Patient-Rated Questionnaire (GSRS) [ Time Frame: Week 25 ]
  • Patient-Rated Questionnaire (SF-36) [ Time Frame: Week 0 ]
  • Patient-Rated Questionnaire (SF-36) [ Time Frame: Week 5 ]
  • Patient-Rated Questionnaire (SF-36) [ Time Frame: Week 9 ]
  • Patient-Rated Questionnaire (SF-36) [ Time Frame: Week 13 ]
  • Patient-Rated Questionnaire (SF-36) [ Time Frame: Week 17 ]
  • Patient-Rated Questionnaire (SF-36) [ Time Frame: Week 21 ]
  • Patient-Rated Questionnaire (SF-36) [ Time Frame: Week 25 ]
  • Neurological Exam [ Time Frame: Week 0 ]
  • Neurological Exam [ Time Frame: Week 5 ]
  • Neurological Exam [ Time Frame: Week 9 ]
  • Neurological Exam [ Time Frame: Week 13 ]
  • Neurological Exam [ Time Frame: Week 17 ]
  • Neurological Exam [ Time Frame: Week 21 ]
  • Neurological Exam [ Time Frame: Week 25 ]

Central Contacts and Locations

Locations

IMMUNOe Research Centers

Recruiting

Centennial, Colorado, United States, 80112

Contacts

Maureen Collins

303-771-9000mcollins@immunoe.com

Principal Investigator:

Isaac Melamed, MD

More Information

Sponsor

IMMUNOe Research Centers

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Keywords

  • post-viral fatigue syndrome
  • Post-COVID Symptoms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by IMMUNOe Research Centers on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.