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History of Changes for Study: NCT04362111
Early Identification and Treatment of Cytokine Storm Syndrome in Covid-19
Latest version (submitted November 16, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 23, 2020 None (earliest Version on record)
2 September 8, 2020 Recruitment Status, Outcome Measures, Study Status, Study Design, Arms and Interventions, Study Identification, Contacts/Locations, Eligibility and Oversight
3 August 30, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
4 April 10, 2022 Study Status
5 September 26, 2022 Study Status
6 November 16, 2022 Study Status
Comparison Format:

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Study NCT04362111
Submitted Date:  April 23, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: Chatham-Cytokine Covid-19
Brief Title: Early Identification and Treatment of Cytokine Storm Syndrome in Covid-19
Official Title: Early Identification and Treatment of Cytokine Storm Syndrome in Covid-19
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Overall Status: Not yet recruiting
Study Start: May 2020
Primary Completion: July 2020 [Anticipated]
Study Completion: December 2020 [Anticipated]
First Submitted: April 21, 2020
First Submitted that
Met QC Criteria:
April 23, 2020
First Posted: April 24, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 23, 2020
Last Update Posted: April 24, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Alabama at Birmingham
Responsible Party: Principal Investigator
Investigator: W Winn Chatham
Official Title: Principal Investigator
Affiliation: University of Alabama at Birmingham
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief 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.
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.
Open or close this module Conditions
Conditions: Cytokine Storm
COVID-19
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Two parallel treatment arms. Subjects failing primary outcome will be unblinded and can then receive open label anakinra
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Anakinra Group
The active treatment group will receive anakinra 100 mg subcutaneously every 6 hours for period of 5 days.
Drug: Anakinra
The active treatment group will receive anakinra 100 mg subcutaneously every 6 hours for period of 5 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 5 days.
Drug: Normal saline
The control group will receive normal saline placebo subcutaneously every 6 hours for period of 5 days.
Other Names:
  • NS
Open or close this module Outcome Measures
Primary Outcome Measures:
1. No increase in oxygen requirement and no increase in respiratory support measures
[ Time Frame: 48 hours ]

Supplemental oxygen requirement to maintain oxygen saturation >90% stable or decreased without escalation of respiratory measures (addition of CPAP, initiation of mechanical ventilation)
Secondary Outcome Measures:
1. Improvement in Cytokine Storm markers
[ Time Frame: 72 hours ]

25% decrease in noted baseline elevations of serum ferritin, LDH, CRP, and d-dimer.
2. No requirement for mechanical ventilation
[ Time Frame: Day 5 (120 hours) ]

Subjects discharged from hospital without the need for mechanical ventilation
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. 18 years old or older
  2. Molecular (pcRNA) diagnosis of SARS-CoV-2 infection
  3. Hyperferritinemia (>700 ng/ml)
  4. Fever >38 degrees C
  5. Any two of the following:
    1. Elevated d-dimer (> 500 ng/ml) or thrombocytopenia (< 130,000/mm3)
    2. leucopenia (WBC <3500/mm3) or lymphopenia (<1000/mm3)
    3. elevated AST or ALT (> 2X ULN)
    4. elevated LDH (> 2X ULN)

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
Open or close this module Contacts/Locations
Central Contact Person: Walter W Chatham, MD
Telephone: 800-822-6478
Email: wchatham@uabmc.edu
Central Contact Backup: Angela Kendrach
Telephone: 205-996-5602
Email: akendrach@uab.edu
Study Officials: Walter W Chatham, MD
Principal Investigator
University of Alabama at Birmingham
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Yes
Contact PI by e-mail for protocol specifics Submission of results for peer reviewed publication
Supporting Information:
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame:
During study enrollment
Access Criteria:
wchatham@uabmc.edu
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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