SARS-CoV 2Phase 2SARICORNCT04357860
Clinical Trial of Sarilumab in Adults With COVID-19
A Phase 2 study testing Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA], Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] and Best available treatment in people with SARS-CoV 2 and SARS, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
Early administration of sarilumab in hospitalized patients infected with COVID-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal oxygenation (HFNO) or either invasive or non-invasive… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SARS-CoV 2, SARS
- What is being tested?
- Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA], Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] and Best available treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 28 Apr 2020to 6 Apr 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and <75 years
- Admission for confirmed respiratory symptoms to COVID-19 based on a positive PCR in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring ONAF or mechanical ventilation
- Interstitial pneumonia confirmed by chest radiography or CT
- IL-6 levels> 40 pg / ml. In its absence, D-Dimer (DD)> 1500 or> 1000 may be included if progressive increases are documented
- Negative pregnancy test in women of childbearing age
- Signature of informed consent
Who cannot join
- SOFA score> 6 points
- Patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation
- Neutrophil count <2 x 103 / μL
- Platelet count <100 x 103 / μL
- ALT or AST levels> 5 times the upper limit of normal
- Severe renal failure (CrCr <30 ml / min)
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- Active bacterial infectious process
- Active tuberculosis, history of not completing treatment against tuberculosis, suspicion of extrapulmonary tuberculosis
- History of intestinal ulcer or diverticulitis
- History of hypersensitivity reactions to Sarilumab or its excipients
- Treatment with TNF antagonists
- Previous treatment with anti-IL6 in the previous 30 days
- Chronic prior treatment with corticosteroids at doses greater than 0.5 mg / kg / day of prednisone or equivalent. Yes, inhaled and topical corticosteroids are acceptable
- Concomitant treatment with immunomodulators, among which are Vitamin D or statins. Macrolides such as azithromycin are acceptable
- Patients on immunosuppressive treatment for any cause
- HIV-infected patients with CD4 <200 / mm3
- Past or current history of autoimmune disease or systemic inflammatory disease
- Patients who have received or are planning therapy with immunomodulatory antibodies, including immunoglobulins
- Participation in any clinical trial that evaluated any investigational product in the last 3 months or less than 5 half-lives of the investigational product
- Pregnancy
- Any other condition that, in clinical judgment, prevents adherence to the patient's protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial of Sarilumab in Adults Hospitalized With COVID-19 Presenting Cytokine Release Syndrome
Early administration of sarilumab in hospitalized patients infected with COVID-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal oxygenation (HFNO) or either invasive or non-invasive mechanical ventilation.
- Conditions
- SARS-CoV 2, SARS
- Being tested
- Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA], Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA], Best available treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]Drug
Best available treatment up to 14 days plus Sarilumab 200 mg
Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]Drug
Best available treatment up to 14 days plus Sarilumab 400 mg
Best available treatmentDrug
Best available treatment up to 14 days
| Study group | Role | What they receive |
|---|---|---|
| Sarilumab 200 mg | Experimental | Subjects treated with the best available treatment up to 14 days plus Sarilumab 200 mg single dose. Receives: Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA] |
| Sarilumab 400 mg | Experimental | Subjects treated with the best available treatment up to 14 days plus Sarilumab 400 mg single dose. Receives: Drug: Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] |
| Control | Active comparator | Subjects treated with the best available treatment up to 14 days. Receives: Drug: Best available treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation requirements
Proportion of patients requiring or time (in days) until required:
- High flow nasal oxygenation (HFNO)
- Non-invasive mechanical ventilation type BiPAP
- Non-invasive mechanical ventilation type CPAP
- Invasive mechanical ventilation
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Secondary outcomes (15)
Crude mortality
Crude mortality at 28 days
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Time to clinical improvement
Time to clinical improvement: defined as the mean change or time in days from randomization to any of the following criteria: (i) improvement of two points on the ordinal scale of 7 points of severity or, (ii) hospital discharge with lifetime. The criteria reached before are used. The 7 point gravity scale includes the following categories:
- - Not hospitalized with normal activity
- - Not hospitalized but unable to have normal activity
- - Hospitalized, without requiring oxygen supplementation
- - Hospitalized, requiring oxygen supplementation
- - Hospitalized, requiring ONAF, non-invasive mechanical ventilation or both
- - Hospitalized requiring ECMO, invasive mechanical ventilation or both
- - Death
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Time until improvement in oxygenation
Time (in days) until improvement in oxygenation for at least 48 hours:
- Time to verify an increase in the SpO2 / FiO2 ratio with respect to the worst SpO2 / FiO2 prior to treatment with Sarilumab and stratified according to levels of IL-6 or DD
- Time to absence of oxygen requirement to maintain saturation in ambient air ≥ 93%
- Number of days in need of supplemental oxygen
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Proportion of patients requiring invasive mechanical ventilation
Proportion of patients requiring invasive mechanical ventilation in the trial
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Proportion of patients having negative COVID-19 CRP at each visit
Proportion of patients having negative COVID-19 CRP at each visit of the trial
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Mean of serum cytokine levels
Mean of serum cytokine levels: the panel of cytokines to quantify; IL1-��, IL1-β, IL6, IL8, IL10, IL12, IL18, IL38, INFɣ, TNF��, CCL2, CCL3, CCL4, MIF and PAI-1
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Adverse events related to medication and its administration
Incidence of adverse events related to medication and its administration
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Incidence in the appearance of serious bacterial, fungal or opportunistic infections
Incidence in the appearance of serious bacterial, fungal or opportunistic infections in the subjects
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Incidence of perforation of the gastrointestinal tract
Incidence of perforation of the gastrointestinal tract in subjects
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Leukocyte and neutrophil count
Leukocyte and neutrophil count mean
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Hemoglobin levels
Mean hemoglobin levels
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Platelet count
Platelet count mean
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Levels of creatinemia
Average levels of creatinemia
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Bilirubin levels
Average bilirubin levels
Measured: At day 28 or when the subject is discharged (whichever occurs first)
ALT and AST levels
ALT and AST average levels
Measured: At day 28 or when the subject is discharged (whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start28 Apr 2020
- Primary completion9 Mar 2021
- Study completion6 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Junta de Andalucia, Red Andaluza de Ensayos Clínicos en Enfermedades Infecciosas (Red ANCRAID)
- Responsible party
- Sponsor
- Investigators
- Julián de la Torre Cisneros, MD, Study director, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357860
- Sponsor's protocol ID
- SARICOR
- Acronym
- SARICOR
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the information will be published and it will be available in open access.
Publications
Merchante N, Carcel S, Garrido-Gracia JC, Trigo-Rodriguez M, Moreno MAE, Leon-Lopez R, Espindola-Gomez R, Alonso EA, Garcia DV, Romero-Palacios A, Perez-Camacho I, Gutierrez-Gutierrez B, Martinez-Marcos FJ, Fernandez-Roldan C, Perez-Crespo PMM, Cano AA, Leon E, Corzo JE, de la Fuente C, Torre-Cisneros J. Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0210721. doi: 10.1128/AAC.02107-21. Epub 2021 Dec 13.
PubMed 34902262Leon Lopez R, Fernandez SC, Limia Perez L, Romero Palacios A, Fernandez-Roldan MC, Aguilar Alonso E, Perez Camacho I, Rodriguez-Bano J, Merchante N, Olalla J, Esteban-Moreno MA, Santos M, Luque-Pineda A, Torre-Cisneros J. Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial. BMJ Open. 2020 Nov 14;10(11):e039951. doi: 10.1136/bmjopen-2020-039951.
PubMed 33191263
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Sarilumab in Adults Hospitalized With COVID-19 Presenting Cytokine Release Syndrome
- ClinicalTrials.gov ID
- NCT04357860
- Acronym / sponsor ID
- SARICOR / SARICOR
- Conditions
- SARS-CoV 2, SARS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Junta de Andalucia, Red Andaluza de Ensayos Clínicos en Enfermedades Infecciosas (Red ANCRAID)
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 6 Apr 2021 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Early administration of sarilumab in hospitalized patients infected with COVID-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal oxygenation (HFNO) or either invasive or non-invasive mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sarilumab 200 mg | Experimental | Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]Subjects treated with the best available treatment up to 14 days plus Sarilumab 200 mg single dose. |
| Sarilumab 400 mg | Experimental | Drug: Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]Subjects treated with the best available treatment up to 14 days plus Sarilumab 400 mg single dose. |
| Control | Active comparator | Drug: Best available treatmentSubjects treated with the best available treatment up to 14 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years and <75 years
- Admission for confirmed respiratory symptoms to COVID-19 based on a positive PCR in a sample of the respiratory tract in the local laboratory in the absence of respiratory distress syndrome requiring ONAF or mechanical ventilation
- Interstitial pneumonia confirmed by chest radiography or CT
- IL-6 levels> 40 pg / ml. In its absence, D-Dimer (DD)> 1500 or> 1000 may be included if progressive increases are documented
- Negative pregnancy test in women of childbearing age
Key exclusion criteria (21 listed)
- SOFA score> 6 points
- Patient who, in the researcher's opinion, is not a subsidiary of invasive mechanical ventilation
- Neutrophil count <2 x 103 / μL
- Platelet count <100 x 103 / μL
- ALT or AST levels> 5 times the upper limit of normal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]Best available treatment up to 14 days plus Sarilumab 200 mg | Drug | Sarilumab 200 mg |
| Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]Best available treatment up to 14 days plus Sarilumab 400 mg | Drug | Sarilumab 400 mg |
| Best available treatmentBest available treatment up to 14 days | Drug | Control |
Primary outcome
Ventilation requirements
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Proportion of patients requiring or time (in days) until required: * High flow nasal oxygenation (HFNO) * Non-invasive mechanical ventilation type BiPAP * Non-invasive mechanical ventilation type CPAP * Invasive mechanical ventilation
15 secondary outcomes
Crude mortality
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Time to clinical improvement
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Time until improvement in oxygenation
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Proportion of patients requiring invasive mechanical ventilation
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Proportion of patients having negative COVID-19 CRP at each visit
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Mean of serum cytokine levels
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Adverse events related to medication and its administration
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Incidence in the appearance of serious bacterial, fungal or opportunistic infections
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Incidence of perforation of the gastrointestinal tract
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Leukocyte and neutrophil count
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Hemoglobin levels
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Platelet count
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Levels of creatinemia
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Bilirubin levels
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
ALT and AST levels
Time frame: At day 28 or when the subject is discharged (whichever occurs first)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Derived from this study: PubMed 34902262Merchante N, Carcel S, Garrido-Gracia JC, Trigo-Rodriguez M, Moreno MAE, Leon-Lopez R, Espindola-Gomez R, Alonso EA, Garcia DV, Romero-Palacios A, Perez-Camacho I, Gutierrez-Gutierrez B, Martinez-Marcos FJ, Fernandez-Roldan C, Perez-Crespo PMM, Cano AA, Leon E, Corzo JE, de la Fuente C, Torre-Cisneros J. Early Use of Sarilumab in Patients Hospitalized with COVID-19 Pneumonia and Features of Systemic Inflammation: the SARICOR Randomized Clinical Trial. Antimicrob Agents Chemother. 2022 Feb 15;66(2):e0210721. doi: 10.1128/AAC.02107-21. Epub 2021 Dec 13.
- Derived from this study: PubMed 33191263Leon Lopez R, Fernandez SC, Limia Perez L, Romero Palacios A, Fernandez-Roldan MC, Aguilar Alonso E, Perez Camacho I, Rodriguez-Bano J, Merchante N, Olalla J, Esteban-Moreno MA, Santos M, Luque-Pineda A, Torre-Cisneros J. Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial. BMJ Open. 2020 Nov 14;10(11):e039951. doi: 10.1136/bmjopen-2020-039951.
- Individual participant dataSharing planned: Yes. All the information will be published and it will be available in open access.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julián de la Torre Cisneros, MD study director
Hospital General Universitario Reina Sofía de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA], Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] and Best available treatment in people with SARS-CoV 2 and SARS, run by Maimónides Biomedical Research Institute of Córdoba 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 6 inclusion and 21 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 7 Jul 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?
Ventilation requirements (time frame: At day 28 or when the subject is discharged (whichever occurs first)). 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 NCT04357860, 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 7 Jul 2021.