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

Covid-19 Clinical Trial

— SARCOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04357808
• Other study ID #: SARCOVID
• Secondary ID: 2020-001634-36
• Status: Completed
• Phase: Phase 2
• Start date: April 13, 2020
• Est. completion date: December 4, 2020

Study information

• Verified date: February 2021
• Source: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 4, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. Fever = 37.8ºC (tympanic)

2. 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

3. Lymphocytes <600 mm3

4. Ferritin> 300 mcg / L that doubles in 24 hours

5. Ferritin> 600 mcg / L in the first determination and LDH> 250 U / L

6. 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.

Related Conditions & MeSH terms

• Covid-19
• Infection

Intervention

Drug:
• Sarilumab
Single dose treatment with sarilumab 2 x 200 mg subcutaneously

Other:
• Standar of care
Usual clinical care

Locations

Country	Name	City	State
Spain	Hospital Universitario de la Princesa	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Maria del Rosario Garcia de Vicuña Pinedo	Instituto de Investigación Sanitaria Hospital Universitario de la Princesa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of serious and non-serious adverse events.	Number of adverse events and number of patients with adverse events	30 days after enrolment
Other	Discontinuation due to adverse reactions	Number of adverse reactions that requires discontinuation of any drug in the study	30 days after enrolment
Primary	Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation	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	7 days from enrolment
Primary	Duration of hospitalisation (days)	Days from the date of enrolment to the date of discharge	30 days from enrolment
Primary	Death	Number of deaths	30 days from enrolment
Secondary	Time to become afebrile (days)	Time to become afebrile for a minimum period of 48 hours, without antipyretics	30 days from enrolment
Secondary	Time to non-invasive mechanical ventilation (days)	Days from enrolment to non-invasive mechanical ventilation	30 days from enrolment
Secondary	Time to invasive mechanical ventilation (days)	Days from enrolment to invasive mechanical ventilation	30 days from enrolment
Secondary	Time to independence from supplementary oxygen therapy (days)	Days from enrolment to supplementary oxygen therapy withdrawal	30 days from enrolment
Secondary	Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation	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	14 days from enrolment