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.

Standard of care as directed by the treating clinicians.

COVID

Single dose of 400 mg subcutaneous sarilumab

SARILUMAB

VA Connecticut Healthcare System

VA Boston Healthcare System

VA Medical Center - White River Junction

Sarilumab for Patients With Moderate COVID-19 Disease

Sarilumab for Patients With Moderate COVID-19 Disease: A Randomized Controlled Trial With a Play-The-Winner Design

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.

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

In order to achieve these objectives, clinical data and blood sample results obtained through the MUHC LEGACY Biobank (directed by Dr. Evelyne Vinet) will be analysed. The objective of the LEGACY Biobank (the "Bank") is the conservation of blood samples; more specifically, plasma, sera, and crude white cell pellet and clinical data ("material/data") collected from an international multi-centre prospective cohort of pregnant women with systemic lupus erythematosus (SLE).

Systemic Lupus Erythematosus

Pregnancy Complications

James G, Witten D, Hastie T, Tibshirani R. An Introduction to Statistical Learning—With Applications in R. New York: Springer; 2013.

McGill University Health Centre

The Lupus prEGnAnCY Cohort: An International Prospective Cohort of Lupus Pregnancies

Fetal death, neonatal death, preterm delivery or termination of pregnancy, and small for gestational age neonate confirmed by chart review and autopsy report.

The Adherence to Refills and Medications Scale (ARMS), a validated self-reported questionnaire developed for patients with chronic disease with low literacy, measures ASA adherence. A self-reported aspirin adherence questionnaire consisting of 3 to 6 questions about the use of aspirin during current pregnancy measures ASA use. A visual analogue scale from 0 to 10 measures frequency of ASA ingestion. Change in ASA use will be measured by the questionnaires. Frequencies of dosage of ASA will also be measured.

Baseline covariates such as lupus anticoagulant antibodies, a subtype of anticoagulant antibodies, Antiphosphatidylserine/prothrombin antibodies (aPS/PT), antihypertensive use, disease activity, platelet levels will be measured and defined by the physician-in-charge. Nephritis history, race/ethnicity, nulliparity, maternal age, pre-gestational diabetes, obsesity (BMI above 30) and medication use (corticosteroids, antimalarials, immunosuppressive and low-dose aspirin) will be characterized.
Measures for disease activity include the SLE Pregnancy Disease Activity Index (SLEPDAI), a widely-recognized adaptation of the validated SLE Disease Activity Index, reflects disease activity in pregnancy context.

Positive results for Antiphosphatidylserine/prothrombin antibodies (aPS/PT) and and lupus anticoagulant results in pregnant women with SLE with and without adverse pregnancy outcomes

Information will be kept between investigators.

Evelyne Vinet

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

Duke University

University of California, Los Angeles

Dalhousie University

Hanyang University

Hospital for Special Surgery, New York

Johns Hopkins University

Monash University

New York University

Oklahoma Medical Research Foundation

University of North Carolina

Temple University

University of Alabama at Birmingham

University of Birmingham

University of Calgary

University of California

University of Copenhagen

University of Manitoba

University of Michigan

University of Toronto

NYU Langone Health

University of British Columbia

National Institute of Medical Science & Nutrition

Laval University

University Health Network, Toronto

Chloroquine placebo one tablet daily for 3 weeks

80mg chloroquine or placebo tablet weekly for Weeks 1-3

Metabolic Syndrome X

Overweight

Hypertension

Dyslipidemias

Prediabetic State

1 chloroquine placebo tablet for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells

Placebo Comparator Limb 1

80mg chloroquine or placebo tablet weekly for Weeks 1-3;euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells

Chloroquine

80mg tablet daily for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells

250mg tablet daily for 3 weeks; euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells

click here for Washington University Research Participant Registry

Washington University in St. Louis

Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS)

Genotoxic Stress, Atherosclerosis, and Metabolic Syndrome-AIM 2

Washington University School of Medicine

National Heart, Lung, and Blood Institute (NHLBI)

Participants will receive 80 mg of chloroquine on a daily basis.

Participants will receive a placebo comparator tablet on a daily basis.

One tablet of 80 mg of chloroquine on a daily basis for 12 months followed by 12 months off drug with 1 visit at month 24

Chloroquine Placebo tablet daily for 12 months followed by 12 months off drug with 1 visit at month 24

Placebo Comparator

Atheroma Reduction With Chloroquine in Patients With the Metabolic Syndrome (ARCH-MS)

Genotoxic Stress, Atherosclerosis, and Metabolic Syndrome- Aim 3

A noninvasive predictor of cardiovascular events, Carotid artery intima-media thickness (CIMT) was measured from B-mode images by a single sonographer using standard approaches

antimalarial/lihavuus

Sarilumab for Patients With Moderate COVID-19 Disease

The Lupus prEGnAnCY Cohort: An International Prospective Cohort of Lupus Pregnancies

Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS)

Atheroma Reduction With Chloroquine in Patients With the Metabolic Syndrome (ARCH-MS)

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