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Early Identification and Treatment of Cytokine Storm Syndrome in Covid-19

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ClinicalTrials.gov Identifier: NCT04362111
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
W Winn Chatham, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Cytokine Storm COVID-19 Drug: Anakinra Drug: Normal saline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two parallel treatment arms. Subjects failing primary outcome will be unblinded and can then receive open label anakinra
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Investigator, care provider, and participant blinded until primary outcome assessed; non-responders in placebo arm may cross-over to open-label anakinra
Primary Purpose: Treatment
Official Title: Early Identification and Treatment of Cytokine Storm Syndrome in Covid-19
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arm Intervention/treatment
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 Name: 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 Name: NS




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362111


Contacts
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Contact: Walter W Chatham, MD 800-822-6478 wchatham@uabmc.edu
Contact: Angela Kendrach 205-996-5602 akendrach@uab.edu

Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Walter W Chatham, MD University of Alabama at Birmingham
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Responsible Party: W Winn Chatham, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04362111    
Other Study ID Numbers: Chatham-Cytokine Covid-19
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Contact PI by e-mail for protocol specifics Submission of results for peer reviewed publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: During study enrollment
Access Criteria: wchatham@uabmc.edu

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents