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Sarilumab for Patients With Moderate COVID-19 Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359901
Recruitment Status : Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Westyn Branch-Elliman, VA Boston Healthcare System

Brief Summary:

Objectives: To determine whether blockade of IL-6R is beneficial in patients with COVID-19 infection of moderate severity.

Research Design: Randomized, controlled trial. Two-arm trial comparing standard care alone to standard care with addition of sarilumab (anti-IL6R). The trial will use a randomized play-the-winner design, in which randomization becomes weighted toward the arm that was more effective in previous subjects in the trial.

Methodology Hospitalized patients meeting clinical criteria for moderate disease and testing positive for coronavirus infection. Interventions: sarilumab, 400 mg subcutaneous injection. Standard care is not pre-specified, may vary among patients, and may include agents with anti-viral activity, such as remdesivir or hydroxychloroquine, among others. Up to 120 patients, primary outcome intubation or death within 14 days. All data will be extracted remotely from the electronic health record (EHR).

Clinical Implications: The study has potential to establish IL-6R blockade, delivered subcutaneously, as standard of care in reducing progression to critical illness in patients with moderate COVID-19 disease.


Condition or disease Intervention/treatment Phase
COVID Biological: SARILUMAB Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sarilumab for Patients With Moderate COVID-19 Disease: A Randomized Controlled Trial With a Play-The-Winner Design
Actual Study Start Date : April 10, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Sarilumab

Arm Intervention/treatment
Active Comparator: Standard of care plus subcutaneous sarilumab
Standard of care as directed by the treating clinicians, plus sarilumab 400 mg subcutaneous injection. Sarilumab is provided in prefilled syringes/pens containing 200 mg each as is used clinically, and both injections will be given as soon as is convenient after the patient has decided to enroll.
Biological: SARILUMAB
Single dose of 400 mg subcutaneous sarilumab
Other Name: KEVZARA

No Intervention: Standard of care
Standard of care as directed by the treating clinicians.



Primary Outcome Measures :
  1. Intubation or death [ Time Frame: within 14 Days of enrollment ]
    Composite outcome of intubation or death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Study subjects will be inpatients with confirmed SARS-CoV-2 testing. Testing is performed at the discretion of the treating physician. Only Veterans will be enrolled.

Inclusion Criteria:

  1. Positive testing for novel coronavirus SARS-CoV-2019
  2. Patients with moderate COVID-19 disease as defined clinically:

    1. Score of 1-3 (out of 3) on a modified Brescia COVID respiratory severity score (BCRSS), elements of which include wheezing or inability to speak complete sentences without effort, respiratory rate ≥22, O2 saturation ≤ 94% with or without supplemental oxygen, or requiring ≥2L supplemental oxygen to maintain O2 Sat >94% in patients without previously documented hypoxia or baseline oxygenation requirement; either is equal to one point on the score) all within a 24-hour period prior to enrollment, and/or any worsening of chest X-ray (CXR) findings after COVID-19 diagnosis
    2. Worsening of baseline oxygenation by at least 3%, or increase in oxygen requirement by at least 2L, in patients with pre-existing hypoxemia or receiving supplemental oxygen chronically.
    3. The BCRSS risk calculation score is available at: https://www.mdcalc.com/brescia-covid-respiratory-severity-scale-bcrss-algorithm

Exclusion Criteria:

  1. Critical disease, defined by need for mechanical ventilation
  2. Expected death within 48 hours
  3. Patients taking any of the following for chronic inflammatory diseases: glucocorticoids equivalent to prednisone > 10 mg/day (methylprednisolone > 8 mg/day, dexamethasone > 2 mg/day), a JAK inhibitor (tofacitinib, baricitinib, upadacitinib), or a biologic

    1. Use of chronic inhaled steroids is NOT an exclusion
    2. Current or recent short-term use of glucocorticoids for chronic conditions such as COPD or gout is NOT an exclusion.
    3. Current use of glucocorticoids for COVID-19 is NOT an exclusion
    4. Use of biologics for non-inflammatory diseases is NOT an exclusion
  4. Receipt of any IL-6 inhibitor within 3 months prior to enrollment in the trial
  5. Pregnancy, due to lack of fetal monitoring capabilities
  6. Patients enrolled in other interventional clinical trials, including for COVID-19. Patients enrolled in non-interventional studies or receiving non-FDA-approved drugs for compassionate use are not excluded.
  7. Patients whose goal of care is comfort measures only
  8. Inability to provide informed consent, or absence of a legally authorized representative to provide informed consent.
  9. Severe psychiatric disease that prevents compliance with typical medical care.
  10. Initial positive test for active infection with novel coronavirus SARS-CoV-2019 was >4 weeks prior to current admission.

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): NCT04359901


Locations
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United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
United States, Maine
VA Maine Healthcare System
Augusta, Maine, United States, 04330
United States, Massachusetts
VA Boston Healthcare System
Boston, Massachusetts, United States, 02132
United States, Rhode Island
Providence VA Medical Center
Providence, Rhode Island, United States, 02908
United States, Vermont
VA Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
Westyn Branch-Elliman
Investigators
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Principal Investigator: Westyn Branch-Elliman, MD VA Boston Healthcare System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Westyn Branch-Elliman, Assistant Professor of Medicine, Harvard Medical School; Investigator, VA Boston Center for Healthcare Organization and Implementation Research; Infectious Disease Consultant, VA Boston Healthcare System, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT04359901    
Other Study ID Numbers: IRB 3305
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Digital data underlying primary scientific publications will be held as part of a data sharing resource. Study data held for this purpose may include data, data content, format, and organization. The data may contain but are not limited to individually identifiable information, other PHI, and study codes. The data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy that prioritize protecting participants' privacy and confidentiality to the fullest extent possible. A detailed plan will be developed in accordance with current technology, infrastructure, best practices, and policies and procedures in place at the time of oversight committee reviews (e.g., Privacy Board, Information Security, and Information Technology standards). The plan will include how data will be discovered, retrieved, analyzed, and managed and will note the materials that are available in machine-readable formats.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Within one year of primary publication.
Access Criteria: Consistent with VA Privacy, Regulatory and IT requirements and VHA Handbook 1200.12

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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