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Can an arthritis drug tame severe COVID-19? trial results in.

NCT ID NCT04327388

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 study tested the drug sarilumab (Kevzara®) in 420 adults hospitalized with severe or critical COVID-19. Participants received either sarilumab or a placebo by IV. The main goal was to see if sarilumab speeds up clinical improvement. The trial also tracked survival, need for oxygen, and safety. Results help clarify whether this anti-inflammatory drug benefits COVID-19 patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sarilumab (Kevzara®)
What this could lead to
If successful, sarilumab could become a treatment option to help hospitalized COVID-19 patients recover faster and reduce the need for intensive care.
What could go wrong
This trial is completed, but results may not apply to all patients. Sarilumab can increase risk of serious infections and side effects like liver enzyme elevations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

420 people

The number who actually took part.

Started

Mar 2020

Finished

Sep 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria : Participants must be \>=18 years of age. Participants must be hospitalized for less than or equal to 7 days with evidence of pneumonia and have one of the following disease categories: severe disease or critical disease. Laboratory-confirmed severe acute respiratory syndrome coronavirus 2 infection. Exclusion criteria: Unlikely to survive after 48 hours from screening or unlikely to remain at the investigational site beyond 48 hours. Participants with multi organ dysfunction or requiring extracorporeal life support or renal replacement therapy were excluded. Presence of neutropenia less than 2000/cubic millimeter (mmˆ3), aspartate transaminase or ALT greater than 5X ULN, platelets less than 50,000/mmˆ3. Prior immunosuppressive therapies. Use of systemic chronic corticosteroids for non-COVID-19 related condition. Known or suspected history of tuberculosis. Suspected or known active systemic bacterial or fungal infections. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 Orthocoronavirinae infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Corona virus infection

Contacts and locations

Locations

  • Investigational Site Number 0320001

    Caba, 1430, Argentina

  • Investigational Site Number 0320003

    Caba, C1180AAX, Argentina

  • Investigational Site Number 0320004

    Caba, C1426AAM, Argentina

  • Investigational Site Number 0760001

    São Paulo, 01327-001, Brazil

  • Investigational Site Number 0760002

    São Paulo, 04231-030, Brazil

  • Investigational Site Number 0760003

    Porto Alegre, 90110-270, Brazil

  • Investigational Site Number 0760004

    São José do Rio Preto, 15090-000, Brazil

  • Investigational Site Number 0760005

    São Paulo, 04321-120, Brazil

  • Investigational Site Number 1240001

    Montreal, H2X3E4, Canada

  • Investigational Site Number 1240002

    Toronto, M5G 2N2, Canada

  • Investigational Site Number 1240003

    Vancouver, V5Z 1M9, Canada

  • Investigational Site Number 1240004

    Toronto, M4N3M5, Canada

  • Investigational Site Number 1240005

    Montreal, H4A 3J1, Canada

  • Investigational Site Number 1520001

    Talca, 3460001, Chile

  • Investigational Site Number 1520002

    Santiago, 80004005, Chile

  • Investigational Site Number 1520003

    Santiago, 750-0691, Chile

  • Investigational Site Number 1520004

    Santiago, Chile

  • Investigational Site Number 2500001

    Bordeaux, 33076, France

  • Investigational Site Number 2500002

    Nantes, 44093, France

  • Investigational Site Number 2500003

    Strasbourg, 67098, France

  • Investigational Site Number 2500004

    Suresnes, 92151, France

  • Investigational Site Number 2500005

    Paris, 75877, France

  • Investigational Site Number 2500006

    La Roche-sur-Yon, 85925, France

  • Investigational Site Number 2500007

    Clamart, 92140, France

  • Investigational Site Number 2760001

    Münster, 48149, Germany

  • Investigational Site Number 2760002

    Essen, 45147, Germany

  • Investigational Site Number 2760004

    Cologne, 50937, Germany

  • Investigational Site Number 3760001

    Ramat Gan, 52662, Israel

  • Investigational Site Number 3760002

    Jerusalem, 91120, Israel

  • Investigational Site Number 3800001

    Milan, 20132, Italy

  • Investigational Site Number 3800002

    Milan, 20157, Italy

  • Investigational Site Number 3800003

    Modena, 41100, Italy

  • Investigational Site Number 3800004

    Parma, 43100, Italy

  • Investigational Site Number 3800005

    Milan, 20122, Italy

  • Investigational Site Number 3800006

    Rozzano, 20089, Italy

  • Investigational Site Number 3920001

    Kamakura-Shi, Japan

  • Investigational Site Number 3920002

    Fuchu-Shi, Japan

  • Investigational Site Number 3920003

    Iruma-Gun, Japan

  • Investigational Site Number 6430001

    Moscow, 129301, Russia

  • Investigational Site Number 6430002

    Moscow, 123182, Russia

  • Investigational Site Number 6430003

    Moscow, 111539, Russia

  • Investigational Site Number 7240001

    Madrid, 28046, Spain

  • Investigational Site Number 7240002

    Madrid, 28007, Spain

  • Investigational Site Number 7240003

    Barcelona, 08035, Spain

  • Investigational Site Number 7240004

    Barcelona, 08036, Spain

  • Investigational Site Number 7240005

    Madrid, 28034, Spain

  • Investigational site number 3760003

    Ashdod, 7747629, Israel

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