Phase 3
N=32
Early Treatment of Cytokine Storm Syndrome in Covid-19
Cytokine Storm · COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04362111 ↗Enrolled (actual)
32
Serious AEs
53.3%
Results posted
Aug 2023
Primary outcome: Primary: Subjects Discharged From the Hospital Alive and Without the Need for Mechanical Ventilation. — 10; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Anakinra (Drug); Normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Discharged From the Hospital Alive and Without the Need for Mechanical Ventilation. |
10; 10 | — |
| SECONDARY Percentage of Subjects With 25% Change (Decrease) in Cytokine Storm Markers at 48-72 Hours After Dosing With Study Agent |
6; 8 | — |
| SECONDARY Percentage of Subjects Without Increase in Oxygen Requirement and no Increase in Oxygen Delivery/Respiratory Support Measures After 48 Hours. |
8; 9 | — |
| SECONDARY Patients Requiring Minimal Oxygen Support at Day 10 |
8; 9 | — |
| SECONDARY Percentage of Subjects With Resolution of Laboratory Markers of Cytokine Storm Syndrome |
0; 7 | — |
| SECONDARY Percentage of Subjects Who Develop Bacterial or Fungal or Non-Covid-19 Viral Infection |
1; 0 | — |
| SECONDARY Absence of Supplemental Oxygen Requirement at Day 10 |
4; 9 | — |
Summary
This proposal addresses the problem of preventing the very high mortality and morbidity associated with the development of Cytokine Storm Syndrome (CSS) associated respiratory failure in Covid-19 infection.
Eligibility Criteria
Inclusion Criteria
- 18 years old or older
- Molecular (pcRNA) diagnosis of SARS-CoV-2 infection
- Chest imaging studies consistent with Covid-19 pneumonia
- Hyperferritinemia (>700 ng/ml)
- History of fever >38 degrees C
- Any three of the following:
- Elevated d-dimer (> 500 ng/ml)
- thrombocytopenia ( 2X ULN)
- elevated LDH (> 2X ULN)
- CRP > 100 mg/L
Exclusion Criteria
- Participation in other investigational treatment protocols for Covid-19 infection
- Culture confirmed active bacterial infection requiring antibiotic therapy
- On mechanical ventilation
- Previous known hypersensitivity reaction to anakinra
- Previous known hypersensitivity reaction to E Coli derived proteins
- Pregnant or breast-feeding females
Data sourced from ClinicalTrials.gov (NCT04362111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.