ClinicalTrials.gg
RecruitingNCT07932002Updated Nov 12, 2026

Exploring the Extended Efficacy and Initial Use of RUCONEST® in Managing Neurological Symptoms Linked to Infectious Pathogens

A Phase 4 interventional study of Ruconest in Post SARS-CoV2 (COVID-19), Post-Viral Fatigue Syndrome and Post-Viral Disorder (Disorder), sponsored by IMMUNOe Research Centers. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by IMMUNOe Research Centers · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Nov 2025, registered Nov 2026).
  • Started Nov 2025; still recruiting 1 year later.
Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,859 studies in COVID-19 with a site in United States — 120 open to participants now, 210 under way, 16 of them phase 3. COVID-19 · United States.

Planned enrollment
951st of 1,321
30 · median 91
Started
2025
with 45 others
Phase 4
60 of 1,859
6 open now
Primary completion
2027-07
later than 135 of 208 live
Registered
1,859th of 1,859
by date

Among the 1,859 studies in COVID-19 with a site in United States, this one is the 951st largest by planned enrollment of the 1,321 interventional ones that give a count, is one of 46 that started in 2025, is one of 60 in phase 4, reaches primary completion later than 135 of the 208 other live ones, and was the 1,859th registered.

COVID-19

7,992 studies on the registry are indexed under COVID-19; 466 are open to participants now.

Browse COVID-19 studies →

Open to participants now

120 of the 1,859 studies in COVID-19 with a site in United States are open now. Recruiting first, the newest first:

114 more — sign in →

All 120 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 356 COVID-19 studies recruiting now, 206 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 135 take healthy volunteers.

This study: 18 Years to 90 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,859 studies in COVID-19 with a site in United States, or all of them as a file.
02

Study summary

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

Read the detailed description

This study will last approximately 30 weeks including 24 infusions total, each one week apart. This is an open label extension study aimed to investigate the continued use of RUCONEST in a post-SARS-CoV-2 population who experienced neurological symptoms both in patients who have participated in the previous trial (NCT04705831) as well as RUCONEST-naive participants.

03

Conditions studied

  • Post SARS-CoV2 (COVID-19)
  • Post-Viral Fatigue Syndrome
  • Post-Viral Disorder (Disorder)
  • COVID - 19

Keywords

  • post-viral fatigue syndrome
  • Post-COVID Symptoms
04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Ruconest

    IV Ruconest

    Drug: Ruconest

Interventions

06

What researchers measure

Primary outcomes

  1. Neuropsychological Measures (BRIEF-A)

    Behavior Rating Inventory of Executive Function - Adult

    Time frame: Week 0

  2. Neuropsychological Measures (BRIEF-A)

    Behavior Rating Inventory of Executive Function - Adult

    Time frame: Week 5

  3. Neuropsychological Measures (BRIEF-A)

    Behavior Rating Inventory of Executive Function - Adult

    Time frame: Week 9

  4. Neuropsychological Measures (BRIEF-A)

    Behavior Rating Inventory of Executive Function - Adult

    Time frame: Week 13

  5. Neuropsychological Measures (BRIEF-A)

    Behavior Rating Inventory of Executive Function - Adult

    Time frame: Week 17

  6. Neuropsychological Measures (BRIEF-A)

    Behavior Rating Inventory of Executive Function - Adult

    Time frame: Week 21

  7. Neuropsychological Measures (BRIEF-A)

    Behavior Rating Inventory of Executive Function - Adult

    Time frame: Week 25

  8. Neuropsychological Measures (RBANS)

    Repeatable Battery for the Assessment of Neuropsychological Status

    Time frame: Week 0

  9. Neuropsychological Measures (RBANS)

    Repeatable Battery for the Assessment of Neuropsychological Status

    Time frame: Week 5

  10. Neuropsychological Measures (RBANS)

    Repeatable Battery for the Assessment of Neuropsychological Status

    Time frame: Week 9

  11. Neuropsychological Measures (RBANS)

    Repeatable Battery for the Assessment of Neuropsychological Status

    Time frame: Week 13

  12. Neuropsychological Measures (RBANS)

    Repeatable Battery for the Assessment of Neuropsychological Status

    Time frame: Week 17

  13. Neuropsychological Measures (RBANS)

    Repeatable Battery for the Assessment of Neuropsychological Status

    Time frame: Week 21

  14. Neuropsychological Measures (RBANS)

    Repeatable Battery for the Assessment of Neuropsychological Status

    Time frame: Week 25

  15. Neuropsychological Measures (BDI II)

    Beck Depression Inventory (BDI II)

    Time frame: Week 0

  16. Neuropsychological Measures (BDI II)

    Beck Depression Inventory (BDI II)

    Time frame: Week 5

  17. Neuropsychological Measures (BDI II)

    Beck Depression Inventory (BDI II)

    Time frame: Week 9

  18. Neuropsychological Measures (BDI II)

    Beck Depression Inventory (BDI II)

    Time frame: Week 13

  19. Neuropsychological Measures (BDI II)

    Beck Depression Inventory (BDI II)

    Time frame: Week 17

  20. Neuropsychological Measures (BDI II)

    Beck Depression Inventory (BDI II)

    Time frame: Week 21

  21. Neuropsychological Measures (BDI II)

    Beck Depression Inventory (BDI II)

    Time frame: Week 25

  22. Neuropsychological Measures (MoCA)

    Montreal Cognitive Assessment (MoCA)

    Time frame: Week 0

  23. Neuropsychological Measures (MoCA)

    Montreal Cognitive Assessment (MoCA)

    Time frame: Week 5

  24. Neuropsychological Measures (MoCA)

    Montreal Cognitive Assessment (MoCA)

    Time frame: Week 9

  25. Neuropsychological Measures (MoCA)

    Montreal Cognitive Assessment (MoCA)

    Time frame: Week 13

  26. Neuropsychological Measures (MoCA)

    Montreal Cognitive Assessment (MoCA)

    Time frame: Week 17

  27. Neuropsychological Measures (MoCA)

    Montreal Cognitive Assessment (MoCA)

    Time frame: Week 21

  28. Neuropsychological Measures (MoCA)

    Montreal Cognitive Assessment (MoCA)

    Time frame: Week 25

  29. Patient-Rated Questionnaire (FSS)

    Fatigue Severity Scale (FSS)

    Time frame: Week 0

  30. Patient-Rated Questionnaire (FSS)

    Fatigue Severity Scale (FSS)

    Time frame: Week 5

  31. Patient-Rated Questionnaire (FSS)

    Fatigue Severity Scale (FSS)

    Time frame: Week 9

  32. Patient-Rated Questionnaire (FSS)

    Fatigue Severity Scale (FSS)

    Time frame: Week 13

  33. Patient-Rated Questionnaire (FSS)

    Fatigue Severity Scale (FSS)

    Time frame: Week 17

  34. Patient-Rated Questionnaire (FSS)

    Fatigue Severity Scale (FSS)

    Time frame: Week 21

  35. Patient-Rated Questionnaire (FSS)

    Fatigue Severity Scale (FSS)

    Time frame: Week 25

  36. Patient-Rated Questionnaire (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Time frame: Week 0

  37. Patient-Rated Questionnaire (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Time frame: Week 5

  38. Patient-Rated Questionnaire (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Time frame: Week 9

  39. Patient-Rated Questionnaire (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Time frame: Week 13

  40. Patient-Rated Questionnaire (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Time frame: Week 17

  41. Patient-Rated Questionnaire (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Time frame: Week 21

  42. Patient-Rated Questionnaire (MIDAS)

    Migraine Disability Assessment (MIDAS)

    Time frame: Week 25

  43. Patient-Rated Questionnaire (HIT)

    Headache Impact Scale (HIT)

    Time frame: Week 0

  44. Patient-Rated Questionnaire (HIT)

    Headache Impact Scale (HIT)

    Time frame: Week 5

  45. Patient-Rated Questionnaire (HIT)

    Headache Impact Scale (HIT)

    Time frame: Week 9

  46. Patient-Rated Questionnaire (HIT)

    Headache Impact Scale (HIT)

    Time frame: Week 13

  47. Patient-Rated Questionnaire (HIT)

    Headache Impact Scale (HIT)

    Time frame: Week 17

  48. Patient-Rated Questionnaire (HIT)

    Headache Impact Scale (HIT)

    Time frame: Week 21

  49. Patient-Rated Questionnaire (HIT)

    Headache Impact Scale (HIT)

    Time frame: Week 25

  50. Patient-Rated Questionnaire (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Time frame: Week 0

  51. Patient-Rated Questionnaire (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Time frame: Week 5

  52. Patient-Rated Questionnaire (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Time frame: Week 9

  53. Patient-Rated Questionnaire (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Time frame: Week 13

  54. Patient-Rated Questionnaire (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Time frame: Week 17

  55. Patient-Rated Questionnaire (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Time frame: Week 21

  56. Patient-Rated Questionnaire (Activities)

    Activities of Daily Living Sliding Scale and Questionnaire

    Time frame: Week 25

  57. Patient-Rated Questionnaire (SF)

    SF McGill Pain Questionnaire

    Time frame: Week 0

  58. Patient-Rated Questionnaire (SF)

    SF McGill Pain Questionnaire

    Time frame: Week 5

  59. Patient-Rated Questionnaire (SF)

    SF McGill Pain Questionnaire

    Time frame: Week 9

  60. Patient-Rated Questionnaire (SF)

    SF McGill Pain Questionnaire

    Time frame: Week 13

  61. Patient-Rated Questionnaire (SF)

    SF McGill Pain Questionnaire

    Time frame: Week 17

  62. Patient-Rated Questionnaire (SF)

    SF McGill Pain Questionnaire

    Time frame: Week 21

  63. Patient-Rated Questionnaire (SF)

    SF McGill Pain Questionnaire

    Time frame: Week 25

  64. Patient-Rated Questionnaire (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Time frame: Week 0

  65. Patient-Rated Questionnaire (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Time frame: Week 5

  66. Patient-Rated Questionnaire (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Time frame: Week 9

  67. Patient-Rated Questionnaire (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Time frame: Week 13

  68. Patient-Rated Questionnaire (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Time frame: Week 17

  69. Patient-Rated Questionnaire (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Time frame: Week 21

  70. Patient-Rated Questionnaire (GSRS)

    Gastrointestinal Symptoms Rating Scale (GSRS)

    Time frame: Week 25

  71. Patient-Rated Questionnaire (SF-36)

    SF-36

    Time frame: Week 0

  72. Patient-Rated Questionnaire (SF-36)

    SF-36

    Time frame: Week 5

  73. Patient-Rated Questionnaire (SF-36)

    SF-36

    Time frame: Week 9

  74. Patient-Rated Questionnaire (SF-36)

    SF-36

    Time frame: Week 13

  75. Patient-Rated Questionnaire (SF-36)

    SF-36

    Time frame: Week 17

  76. Patient-Rated Questionnaire (SF-36)

    SF-36

    Time frame: Week 21

  77. Patient-Rated Questionnaire (SF-36)

    SF-36

    Time frame: Week 25

  78. Neurological Exam

    Complete neurological examination

    Time frame: Week 0

  79. Neurological Exam

    Complete neurological examination

    Time frame: Week 5

  80. Neurological Exam

    Complete neurological examination

    Time frame: Week 9

  81. Neurological Exam

    Complete neurological examination

    Time frame: Week 13

  82. Neurological Exam

    Complete neurological examination

    Time frame: Week 17

  83. Neurological Exam

    Complete neurological examination

    Time frame: Week 21

  84. Neurological Exam

    Complete neurological examination

    Time frame: Week 25

07

Study locations

1 of 1 sites recruiting
  • IMMUNOe Research Centers
    Centennial, Colorado 80112, United States
    Recruiting
    • Maureen Collins · Contactmcollins@immunoe.com · 303-771-9000
    • Isaac Melamed, MD · Principal investigator
    • J. Lynn Williams, MD · Sub investigator
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Jul 2027, 20 months after the start.

Of 44 industry-sponsored phase 4 interventional studies under COVID-19, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 12. This study's planned 20 months is above that.

Counting every sponsor, half of 189 studies reached it within 8 months; a quarter within 4 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartActual
Nov 5, 2025
Primary completionEst.
Jul 31, 2027
CompletionEst.
Oct 29, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07932002
Lead sponsor
IMMUNOe Research Centers
Responsible party
Isaac Melamed, MD (Site Principal Investigator, IMMUNOe Research Centers) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 5, 2025
Primary completion
Jul 31, 2027 (estimated)
Completion
Oct 29, 2027 (estimated)
Last update
Nov 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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