Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 18 years old or older
  2. Molecular (pcRNA) diagnosis of SARS-CoV-2 infection
  3. Chest imaging studies consistent with Covid-19 pneumonia
  4. Hyperferritinemia (>700 ng/ml)
  5. Fever >38 degrees C
  6. Any three of the following:
  7. Elevated d-dimer (> 500 ng/ml)
  8. thrombocytopenia (< 130,000/mm3)
  9. leucopenia (WBC <3500/mm3) or lymphopenia (<1000/mm3)
  10. elevated AST or ALT (> 2X ULN)
  11. elevated LDH (> 2X ULN)
  12. CRP > 100 mg/L

Exclusion Criteria

  1. Participation in other investigational treatment protocols for Covid-19 infection
  2. Culture confirmed active bacterial infection requiring antibiotic therapy
  3. On mechanical ventilation
  4. Previous known hypersensitivity reaction to anakinra
  5. Previous known hypersensitivity reaction to E Coli derived proteins
  6. Pregnant or breast-feeding females

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Two parallel treatment arms
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Masking Description
Investigator, care provider, and participant blinded

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Anakinra Group
The active treatment group will receive anakinra 100 mg subcutaneously every 6 hours for period of 10 days. For subjects meeting complete response criteria at 5 days, dosing will be decreased to 100 mg twice daily for the remaining 5 days.
  • Drug: Anakinra
    The active treatment group will receive anakinra 100 mg subcutaneously every 6-12 hours for a period of 10 days
    Other names:
    • recombinant human IL-ra (rhIL-1ra)
Placebo Comparator
Control Group
The control group will receive normal saline placebo subcutaneously every 6 hours for period of 10 days. For subjects meeting complete repsonse criteria at 5 days, dosing wll be decreased to twice daily for the remaining 5 days.
  • Drug: Normal saline
    The control group will receive normal saline placebo subcutaneously every 6-12 hours for period of 10 days
    Other names:
    • NS

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Angelia Kendrach
akendrach@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Walter W Chatham, MD
800-822-6478
wchatham@uabmc.edu

Detailed Description

The first aim of this project is to determine whether rapidly assayed early clinical laboratory markers of CSS (eCSS: leucopenia, lymphopenia, and elevated ferritin, d-dimer, LDH, CRP, and AST/ALT) in patients admitted to the hospital with respiratory compromise in the setting of Covid-19 infection can accurately identify patients with CSS as defined by validated CSS case definitions (H-Score, aHLH-2004). Confirmation of eCSS predictive of evolving CSS will identify patients at risk for rapid deterioration of lung function and inform early initiation of treatment for CSS. Genotyping studies will also be performed on patients with confirmed CSS to determine whether perforin pathway mutations commonly present in CSS associated with other disorders are present. The second aim is to determine whether early treatment with rhIL-1Ra (anakinra) in patients admitted to the hospital with markers of CSS improves or prevents deterioration of respiratory dysfunction and prevents the development of respiratory failure requiring mechanical ventilation.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.