COVID-19 Drug TreatmentPhase 2STRIKESARSNCT04661527
Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19
A Phase 2 study testing Sarilumab in people with COVID-19 Drug Treatment, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites in Spain.
Trial summary
Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Drug Treatment
- What is being tested?
- Sarilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 22 Apr 2020to 30 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
- Written informed consent prior to performing study procedures. Oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
- In the case of a vital emergency without the possibility of prior consent, a patient may be included in the study if the recommendations of the legislation are followed (RD 1090/2015, article 7), as stated in section 10.3 of the protocol.
- Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
- Negative pregnancy test in case of fertile women*
- Age >= 18
- Infection by COVID-19 confirmed by rtPCR or other validated tests
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- Hospitalized (or documentation of a plan to admit to the hospital if the patient is in the emergency department) with illness of any duration, with evidence of pneumonia, and severe disease as defined by at least one of the following:
- High oxygen requirements (face mask with reservoir, non-invasive mechanical ventilation or high flow nasal cannula)
- Lymphocytes < 0.8 x 109/L
- Serum ferritin > 300ng/mL
- Increased levels of D-dimer (> 1500 ng/mL) or D-dimer progressively increasing (over 3 consecutive measurements) and reaching ≥ 1000 ng/mL.
- CPR > 10 mg/dL, or increasing over 24 hours
Who cannot join
- Patients with any of the following exclusion criteria could not be included in the trial:
- Hypersensitivity to the active substance or any of the excipients listed in section 6
- Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days
- Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline
- Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.
- Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline
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- Tumor necrosis factor (TNF) inhibitors within 2-8 weeks (etanercept within 2 weeks, infliximab, certolizumab, golimumab, or adalimumab within 8 weeks), or after at least 5 half-lives have elapsed, whichever is longer.
- Intravenous immunoglobulin (IVIG) within the past 5 months or plans to receive during the study period
- Current use of chronic oral corticosteroids for a non-COVID-19-related condition in a dose higher than prednisone 10 mg or equivalent per day
- Current treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents
- Patients who have received immunosuppressive antibody therapy within the past 5 months, including intravenous immunoglobulin
- AST/ALT values > 5 x normal.
- Neutropenia (< 0.5 x 109/L).
- Sever thrombocytopenia (< 50 x 109/L).
- Sepsis caused by an alternative pathogen.
- Diverticulitis with risk of perforation.
- Ongoing infectious dermatitis.
- Patients with another active infection, including localized infections.
- Pregnant or breast-feeding females will be excluded
- Positive serology for following infection: HIV, Hepatitis B, or C.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Infanta Leonor
Madrid, 28031
Jesus Troya, MD, +341918297, jesus.troya@salud.madrid.org
Ismael Escobar, MD, +341918297, ismael.escobar@salud.madrid.org
- Recruiting
Clínica Universidad de Navarra, Universidad de Navarra
Pamplona, Navarre, 31008
Javier Zulueta, MD, +34948255400 ext. 4772, jzulueta@unav.es
Gabriel Canel, +34948255400, gcanelc@unav.es
About this study
Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU).
Read the detailed description
Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU).
The primary objective of the trial is to evaluate the impact of sarilumab on the progression of COVID 19-associated respiratory failure as measured by the change in a severity rating on a 7-point severity index. Secondary objectives include the evaluation of safety of the drug and the assessment of the impact of Sarilumab on markers of systemic inflammation and the coagulation cascade, on mortality, and on oxygenation.
The trial has two phases. Firstly, patients with pneumonia in the setting of COVID-19 who meet inclusion criteria and have no exclusion criteria will be treated with 2 doses of 200 mg IV of Sarilumab in 24 hours. After internal review, if no AE are detected and if there is no significant improvement, the next 55 patients will be treated with two doses of 400 mg IV in 24 hours.
- Conditions
- COVID-19 Drug Treatment
- Being tested
- Sarilumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SarilumabDrug
Also called Kevzara®
Treatment with Sarilumab 200 mg IV x 2 doses 24 hours apart for first 5 patients. If no severe AE and no significant improvement within 48 hours, the dose will be increased for subsequent patients to 400 mg IV for the first dose and 200 mg or 400 mg IV for the second dose 24 hours later. Te second dose will be decided at the investigators discretion.
| Study group | Role | What they receive |
|---|---|---|
| Sarilumab arm | Experimental | Not described Receives: Drug: Sarilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in a severity rating on a 7-point ordinal scale
Impact of sarilumab on the progression of COVID-19 associated respiratory failure. A significant improvement in a 7-point severity index is anticipated to occur with treatment with sarilumab.
Measured: 15 days
Secondary outcomes (23)
Percentage of patients reporting each severity rating on a 7-point severity ordinal scale
Proportion of patients in each severity category at the end fo follow-up
Measured: 28 days
Duration of mechanical ventilation
Duration of mechanical ventilation measured by days of ventilation since treatment
Measured: 28 days
Evaluate the safety of sarilumab in patients with severe pneumonia caused by COVID 19
All adverse events will be recorded in the CRF.
Adverse Event is defined as any event that results in worsening of the health of the subject of the clinical trial, regardless of relationship to the experimental therapy. It can be any symptom, sign, illness or experience, including abnormal results of diagnostic procedures, that develops or worsens in severity during the course of the study.
Serious Adverse Event are defined as any AE that is:
- Fatal
- Life-threatening*
- Requires or prolongs hospital stay
- Results in persistent or significant disability or incapacity
Measured: 28 days
Number of ventilator free days in the first 28 days
Number of ventilator free days in the first 28 days
Measured: 28 days
Patients requiring mechanical ventilation
Number and proportion of patients requiring mechanical ventilation
Measured: 28 days
Change from baseline in PaO2/FiO2 in patients on mechanical ventilation
PaO2/FiO2 will be measured daily until extubation or day 28.
Measured: since day of intubation until day of extubation or up to day 28
Time to improvement in oxygenation for at least 48 hours
Increase in SpO2/FiO2 of 50 or more compared to nadir SpO2/FiO2
Measured: 28 days
Time to saturation > 93.9% on room air
Improvement on oxygenation using a threshold of SaO2 of 94% or better when breathing room air as a sign of improvement.
Measured: 28 days
Time to resolution of fever without antipyretics for at least 48 hours (Tº > 36.6ºC - axilla; > 37.2ºC -oral; > 37.8 -rectal or tympanic)
Resolution of fever.
Measured: 28 days
Changes from baseline in white blood cell count if available on V2, V3, V4, V5, and V6
Changes in white blood count on visits number 2, 3 ,4, 5 and 6.
Measured: 28 days
Changes from baseline in hemoglobin levels if available on V2, V3, V4, V5, and V6
Changes in hemoglobin on visits number 2, 3 ,4, 5 and 6.
Measured: 28 days
Changes from baseline in platelet cell count if available on V2, V3, V4, V5, and V
Changes in platelet counts on visits number 2, 3 ,4, 5 and 6.
Measured: 28 days
Changes from baseline in D-Dimer leves if available on V2, V3, V4, V5, and V6
Changes in D-dimer levels on visits number 2, 3 ,4, 5 and 6.
Measured: 28 days
Number of deaths due to any cause
All-cause mortality
Measured: 28 days
Organ failure
Events of organ failure after treatment: DIC, cardiac, hepatic, renal, cardiovascular
Measured: 28 days
Changes from baseline in C Reactive protein if available on V2, V3, V4, V5, and V6
Indicates improvement or worsening of inflammation.
Measured: 28 days
Changes from baseline in Ferritin leves if available on V2, V3, V4, V5, and V6
Indicates improvement or worsening of inflammation.
Measured: 28 days
Changes from baseline in Troponin leves if available on V2, V3, V4, V5, and V6
Indicates potential myocardial involvement.
Measured: 28 days
Changes from baseline in blood urea nitrogen leves if available on V2, V3, V4, V5, and V6
Indicates improvement or worsening of renal function
Measured: 28 days
Changes from baseline in creatinine leves if available on V2, V3, V4, V5, and V6
Indicates improvement or worsening of renal function
Measured: 28 days
Changes from baseline in blilirrubin leves if available on V2, V3, V4, V5, and V6
Indicates improvement or worsening of liver function
Measured: 28 days
Changes from baseline in Aspartate transaminase (AST) leves if available on V2, V3, V4, V5, and V6
Indicates improvement or worsening of liver function
Measured: 28 days
Changes from baseline in Alanine transaminase (ALT) leves if available on V2, V3, V4, V5, and V6
Indicates improvement or worsening of liver function
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start22 Apr 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Drug TreatmentStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Hospital Universitario Infanta Leonor
- Responsible party
- Sponsor
- Investigators
- Javier J Zulueta, MD, Principal investigator, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661527
- Sponsor's protocol ID
- STRIKESARS-COV
- Other IDs
- 2020-001255-40
- Acronym
- STRIKESARS
- Status last verified
- Apr 2020
- First submitted
- 10 Sep 2020
- Last updated
- 16 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarilumab Treatment In cytoKinE Storm Caused by Infection With COVID-19
- ClinicalTrials.gov ID
- NCT04661527
- Acronym / sponsor ID
- STRIKESARS / STRIKESARS-COV
- Conditions
- COVID-19 Drug Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Sanofi, Hospital Universitario Infanta Leonor
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 10 Dec 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.
Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU).
Detailed description
Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU).
The primary objective of the trial is to evaluate the impact of sarilumab on the progression of COVID 19-associated respiratory failure as measured by the change in a severity rating on a 7-point severity index. Secondary objectives include the evaluation of safety of the drug and the assessment of the impact of Sarilumab on markers of systemic inflammation and the coagulation cascade, on mortality, and on oxygenation.
The trial has two phases. Firstly, patients with pneumonia in the setting of COVID-19 who meet inclusion criteria and have no exclusion criteria will be treated with 2 doses of 200 mg IV of Sarilumab in 24 hours. After internal review, if no AE are detected and if there is no significant improvement, the next 55 patients will be treated with two doses of 400 mg IV in 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase II, one-arm, open label, multicentric study, to evaluate treatment of severe COVID-19 with sarilumab prior to entry into the intensive care unit (ICU)
| Arm | Type | Receives |
|---|---|---|
| Sarilumab arm | Experimental | Drug: Sarilumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent prior to performing study procedures. Oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
- In the case of a vital emergency without the possibility of prior consent, a patient may be included in the study if the recommendations of the legislation are followed (RD 1090/2015, article 7), as stated in section 10.3 of the protocol.
- Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
- Negative pregnancy test in case of fertile women*
- Age >= 18
Key exclusion criteria (20 listed)
- Hypersensitivity to the active substance or any of the excipients listed in section 6
- Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days
- Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline
- Cyclosporine (CsA), azathioprine (AZA) or mycophenolate mofetil (MMF) or leflunomide within 4 weeks of baseline.
- Alkylating agents including cyclophosphamide (CYC) within 6 months of baseline
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 |
|---|---|---|
| SarilumabAlso: Kevzara®Treatment with Sarilumab 200 mg IV x 2 doses 24 hours apart for first 5 patients. If no severe AE and no significant improvement within 48 hours, the dose will be increased for subsequent patients to 400 mg IV for the first dose and 200 mg or 400 mg IV for the second dose 24 hours later. Te second dose will be decided at the investigators discretion. | Drug | Sarilumab arm |
Primary outcome
Change in a severity rating on a 7-point ordinal scale
Time frame: 15 days
Impact of sarilumab on the progression of COVID-19 associated respiratory failure. A significant improvement in a 7-point severity index is anticipated to occur with treatment with sarilumab.
23 secondary outcomes
Percentage of patients reporting each severity rating on a 7-point severity ordinal scale
Time frame: 28 days
Duration of mechanical ventilation
Time frame: 28 days
Evaluate the safety of sarilumab in patients with severe pneumonia caused by COVID 19
Time frame: 28 days
Number of ventilator free days in the first 28 days
Time frame: 28 days
Patients requiring mechanical ventilation
Time frame: 28 days
Change from baseline in PaO2/FiO2 in patients on mechanical ventilation
Time frame: since day of intubation until day of extubation or up to day 28
Time to improvement in oxygenation for at least 48 hours
Time frame: 28 days
Time to saturation > 93.9% on room air
Time frame: 28 days
Time to resolution of fever without antipyretics for at least 48 hours (Tº > 36.6ºC - axilla; > 37.2ºC -oral; > 37.8 -rectal or tympanic)
Time frame: 28 days
Changes from baseline in white blood cell count if available on V2, V3, V4, V5, and V6
Time frame: 28 days
Changes from baseline in hemoglobin levels if available on V2, V3, V4, V5, and V6
Time frame: 28 days
Changes from baseline in platelet cell count if available on V2, V3, V4, V5, and V
Time frame: 28 days
Changes from baseline in D-Dimer leves if available on V2, V3, V4, V5, and V6
Time frame: 28 days
Number of deaths due to any cause
Time frame: 28 days
Organ failure
Time frame: 28 days
Changes from baseline in C Reactive protein if available on V2, V3, V4, V5, and V6
Time frame: 28 days
Changes from baseline in Ferritin leves if available on V2, V3, V4, V5, and V6
Time frame: 28 days
Changes from baseline in Troponin leves if available on V2, V3, V4, V5, and V6
Time frame: 28 days
Changes from baseline in blood urea nitrogen leves if available on V2, V3, V4, V5, and V6
Time frame: 28 days
Changes from baseline in creatinine leves if available on V2, V3, V4, V5, and V6
Time frame: 28 days
Changes from baseline in blilirrubin leves if available on V2, V3, V4, V5, and V6
Time frame: 28 days
Changes from baseline in Aspartate transaminase (AST) leves if available on V2, V3, V4, V5, and V6
Time frame: 28 days
Changes from baseline in Alanine transaminase (ALT) leves if available on V2, V3, V4, V5, and V6
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Javier J Zulueta, MD principal investigator
Clinica Universidad de Navarra
2 sites 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 in people with COVID-19 Drug Treatment, run by Clinica Universidad de Navarra, Universidad de Navarra at 2 sites 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 12 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier J Zulueta, MD (+34948255400 ext. 4772, jzulueta@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in a severity rating on a 7-point ordinal scale (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2020.