Efficacy of Subcutaneous Sarilumab in Hospitalised Patients With Moderate-severe COVID-19 Infection (SARCOVID) (SARCOVID)
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ClinicalTrials.gov Identifier: NCT04357808 |
Recruitment Status :
Completed
First Posted : April 22, 2020
Last Update Posted : February 11, 2021
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Condition or disease | Intervention/treatment | Phase |
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Covid-19 | Drug: Sarilumab Other: Standar of care | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention 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) |
Primary Purpose: | Treatment |
Official Title: | Randomized Open Pilot Study to Evaluate the Efficacy of Subcutaneous Sarilumab in Patients With Moderate-severe COVID-19 Infection |
Actual Study Start Date : | April 13, 2020 |
Actual Primary Completion Date : | November 30, 2020 |
Actual Study Completion Date : | December 4, 2020 |

Arm | Intervention/treatment |
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Experimental: Sarilumab plus standard of care
Sarilumab 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
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Drug: Sarilumab
Single dose treatment with sarilumab 2 x 200 mg subcutaneously
Other Names:
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Active Comparator: Standard of care
Treatment with drugs or procedures in routine clinical practice
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Other: Standar of care
Usual clinical care |
- Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation [ Time Frame: 7 days from enrolment ]
Score ranges 1-7
- Death;
- Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);
- Hospitalized, requiring non-invasive ventilation or high flow oxygen devices;
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care
- Not hospitalized
- Duration of hospitalisation (days) [ Time Frame: 30 days from enrolment ]Days from the date of enrolment to the date of discharge
- Death [ Time Frame: 30 days from enrolment ]Number of deaths
- Time to become afebrile (days) [ Time Frame: 30 days from enrolment ]Time to become afebrile for a minimum period of 48 hours, without antipyretics
- Time to non-invasive mechanical ventilation (days) [ Time Frame: 30 days from enrolment ]Days from enrolment to non-invasive mechanical ventilation
- Time to invasive mechanical ventilation (days) [ Time Frame: 30 days from enrolment ]Days from enrolment to invasive mechanical ventilation
- Time to independence from supplementary oxygen therapy (days) [ Time Frame: 30 days from enrolment ]Days from enrolment to supplementary oxygen therapy withdrawal
- Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation [ Time Frame: 14 days from enrolment ]
Scale ranges 1-7:
- Death
- Hospitalized, with mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
- Hospitalized, with non-invasive mechanical ventilation, a mask with a reservoir or oxygen with high flow nasal goggles.
- Hospitalized with oxygen supplement
- Hospitalized, without oxygen supplement, but in need of continued medical care (related or not with COVID)
- Hospitalized, without oxygen supplement and without the need for continued medical care
- Not hospitalized
- Incidence of serious and non-serious adverse events. [ Time Frame: 30 days after enrolment ]Number of adverse events and number of patients with adverse events
- Discontinuation due to adverse reactions [ Time Frame: 30 days after enrolment ]Number of adverse reactions that requires discontinuation of any drug in the study

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age> 18 years
- Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other validated commercial or public health assay
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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
- 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.
Exclusion Criteria:
- 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.
- 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.

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): NCT04357808
Spain | |
Hospital Universitario de la Princesa | |
Madrid, Spain, 28006 |
Principal Investigator: | Rosario Garcia de Vicuña, MD PhD | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
Responsible Party: | Maria del Rosario Garcia de Vicuña Pinedo, MD, PhD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
ClinicalTrials.gov Identifier: | NCT04357808 |
Other Study ID Numbers: |
SARCOVID 2020-001634-36 ( EudraCT Number ) |
First Posted: | April 22, 2020 Key Record Dates |
Last Update Posted: | February 11, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
COVID SARS-CoV-2 coronavirus infections sarilumab IL-6 receptor inhibitors |
Infections COVID-19 Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |