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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04359901|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : June 4, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
Single dose of 400 mg subcutaneous sarilumab
Other Name: KEVZARA
No Intervention: Standard of care
Standard of care as directed by the treating clinicians.
- Intubation or death [ Time Frame: within 14 Days of enrollment ]Composite outcome of intubation or death
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
|Contact: Sara Schiller, MPH||857-364-2012||Sara.Schiller1@va.gov|
|Contact: Colleen Shannon, MPH||Colleen.Shannon@va.gov|
|United States, Massachusetts|
|VA Boston Healthcare System||Recruiting|
|Boston, Massachusetts, United States, 02132|
|Contact: Westyn Branch-Elliman, MD 617-323-7700 Westyn.Branch-Elliman@va.gov|
|Contact: Patricia Woods, RN, MSN Patricia.Woods@va.gov|
|Principal Investigator: Westyn Branch-Elliman, MD|
|Sub-Investigator: Paul Monach, MD|
|Principal Investigator:||Westyn Branch-Elliman, MD||VA Boston Healthcare System|