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Covid-19Phase 2SARCOVIDNCT04357808

Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID)

A Phase 2 study testing Sarilumab and Standar of care in people with Covid-19, run by Maria del Rosario Garcia de Vicuña Pinedo at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The global health emergency created by the rapid spread of the SARS-CoV-2 coronavirus has pushed healthcare services to face unprecedent challenges to properly manage COVID-19 severe and critical manifestations affecting a wide population in a short period of time. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid-19
What is being tested?
Sarilumab and Standar of care
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSpain
Study dates
13 Apr 2020to 4 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age> 18 years
  • Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other validated commercial or public health assay
  • Documented interstitial pneumonia requiring admission and at least two of the following:
  • Fever ≥ 37.8ºC (tympanic)
  • IL-6 in serum ≥ 25 ng / mL (in the absence of a previous dose of prednisone or equivalent> 1 mg / kg) or PCR> 5mg / dL
  • Lymphocytes <600 mm3
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  • Ferritin> 300 mcg / L that doubles in 24 hours
  • Ferritin> 600 mcg / L in the first determination and LDH> 250 U / L
  • D-dimer (> 1 mg / L)
  • Informed verbal or administration consent under urgent conditions, documented in the electronic medical record.

Who cannot join

  • Patients who require mechanical ventilation at the time of inclusion.
  • AST / ALT values > 5 folds upper normal limit.
  • Neutrophil count below 500 cells / mm3
  • Platelet count below 50,000 cells / mm3
  • Documented sepsis or high suspicion by pathogens other than COVID-19.
  • Presence of comorbidities that according to clinical judgment could lead to an unfavorable result.
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  • Complicated diverticulitis or intestinal perforation.
  • Current skin infection (eg, uncontrolled dermopiodermitis).
  • Immunosuppressive anti-rejection therapy.
  • Pregnancy or lactation.
  • Previous treatment with tocilizumab or sarilumab.
  • Patients participating in some other clinical trial for SARS-CoV-2 infection.
  • Patients with known hypersensitivity or contraindication to sarilumab or excipients.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario de la Princesa

    Madrid, 28006

Other trials in Spain

About this study

Official title: Randomized Open Pilot Study to Evaluate the Efficacy of Subcutaneous Sarilumab in Patients With Moderate-severe COVID-19 Infection

The global health emergency created by the rapid spread of the SARS-CoV-2 coronavirus has pushed healthcare services to face unprecedent challenges to properly manage COVID-19 severe and critical manifestations affecting a wide population in a short period of time. Clinicians are committed to do their best with a great uncertainty in this evolving crisis. Off label use of plenty of drugs has arisen the need for clinical trials to demonstrate their true role in the therapy. Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are available yet. Sarilumab is a human monoclonal antibody that binds membrane-bound and soluble IL-6 receptors to inhibit IL-6 signalling, licensed in a subcutaneous route administration.

Read the detailed description

SARCOVID is an investigator-initiated monocentric randomised proof of concept study that aims to evaluate the efficacy and safety of a single dose of sarilumab, in subcutaneous administration, in hospitalised patients with moderate to early severe COVID-19 infection, compared to the current standard of care.

Conditions
Covid-19
Being tested
Sarilumab, Standar of care
Keywords
COVID, SARS-CoV-2, coronavirus infections, sarilumab, IL-6 receptor inhibitors
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SarilumabDrug

    Also called Kevzara, SAR153191

    Single dose treatment with sarilumab 2 x 200 mg subcutaneously

  • Standar of careOther

    Usual clinical care

Study groups in NCT04357808
Study groupRoleWhat they receive
Sarilumab plus standard of careExperimentalSarilumab 200 mg, 2 sc injections in pre-filled syringe or pen, single dose. Treatment with drugs or procedures in routine clinical practice that the clinician responsible for the patient deems necessary is allowed
Receives: Drug: Sarilumab
Standard of careActive comparatorTreatment with drugs or procedures in routine clinical practice
Receives: Other: Standar of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation

    Score ranges 1-7

    1. Death;
    2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
    3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices;
    4. Hospitalized, requiring supplemental oxygen;
    5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
    6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
    7. Not hospitalized

    Measured: 7 days from enrolment

  2. Duration of hospitalisation (days)

    Days from the date of enrolment to the date of discharge

    Measured: 30 days from enrolment

  3. Death

    Number of deaths

    Measured: 30 days from enrolment

Secondary outcomes (5)

  1. Time to become afebrile (days)

    Time to become afebrile for a minimum period of 48 hours, without antipyretics

    Measured: 30 days from enrolment

  2. Time to non-invasive mechanical ventilation (days)

    Days from enrolment to non-invasive mechanical ventilation

    Measured: 30 days from enrolment

  3. Time to invasive mechanical ventilation (days)

    Days from enrolment to invasive mechanical ventilation

    Measured: 30 days from enrolment

  4. Time to independence from supplementary oxygen therapy (days)

    Days from enrolment to supplementary oxygen therapy withdrawal

    Measured: 30 days from enrolment

  5. Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation

    Scale ranges 1-7:

    1. Death
    2. Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
    3. Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles.
    4. Hospitalized with oxygen supplement
    5. Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID)
    6. Hospitalized, without oxygen supplement and without the need for continued medical care
    7. Not hospitalized

    Measured: 14 days from enrolment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2020
  2. Study start13 Apr 2020
  3. Primary completion30 Nov 2020
  4. Study completion4 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomised, open-label, single-center, comparative trial of sarilumab plus standard of care vs. standard of care in a 2:1 ratio.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04357808
Sponsor's protocol ID
SARCOVID
Other IDs
2020-001634-36
Acronym
SARCOVID
Status last verified
Feb 2021
First submitted
14 Apr 2020
Last updated
11 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Garcia-Vicuna R, Rodriguez-Garcia SC, Abad-Santos F, Bautista Hernandez A, Garcia-Fraile L, Barrios Blandino A, Gutierrez Liarte A, Alonso-Perez T, Cardenoso L, Alfranca A, Mejia-Abril G, Sanz Sanz J, Gonzalez-Alvaro I. Subcutaneous IL-6 Inhibitor Sarilumab vs. Standard Care in Hospitalized Patients With Moderate-To-Severe COVID-19: An Open Label Randomized Clinical Trial. Front Med (Lausanne). 2022 Feb 23;9:819621. doi: 10.3389/fmed.2022.819621. eCollection 2022.

    PubMed 35280907

  • Garcia-Vicuna R, Abad-Santos F, Gonzalez-Alvaro I, Ramos-Lima F, Sanz JS. Subcutaneous Sarilumab in hospitalised patients with moderate-severe COVID-19 infection compared to the standard of care (SARCOVID): a structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Sep 9;21(1):772. doi: 10.1186/s13063-020-04588-5.

    PubMed 32907638

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sarilumab and Standar of care in people with Covid-19, run by Maria del Rosario Garcia de Vicuña Pinedo at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation (time frame: 7 days from enrolment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04357808, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.

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