A Phase 2 interventional study of Sarilumab in COVID-19 Drug Treatment, sponsored by Clinica Universidad de Navarra, Universidad de Navarra. Status unknown at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-16.
Sponsored by Clinica Universidad de Navarra, Universidad de Navarra · Phase 2, Interventional, and Treatment
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).
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Clinica Universidad de Navarra, Universidad de Navarra is the lead sponsor of 158 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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:
Exclusion Criteria:
Patients with any of the following exclusion criteria could not be included in the trial:
Drug: Sarilumab
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.
Also known as: Kevzara®
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.
Time frame: 15 days
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
Time frame: 28 days
Duration of mechanical ventilation
Duration of mechanical ventilation measured by days of ventilation since treatment
Time frame: 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
Time frame: 28 days
Number of ventilator free days in the first 28 days
Number of ventilator free days in the first 28 days
Time frame: 28 days
Patients requiring mechanical ventilation
Number and proportion of patients requiring mechanical ventilation
Time frame: 28 days
Change from baseline in PaO2/FiO2 in patients on mechanical ventilation
PaO2/FiO2 will be measured daily until extubation or day 28.
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
Increase in SpO2/FiO2 of 50 or more compared to nadir SpO2/FiO2
Time frame: 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.
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)
Resolution of fever.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 28 days
Number of deaths due to any cause
All-cause mortality
Time frame: 28 days
Organ failure
Events of organ failure after treatment: DIC, cardiac, hepatic, renal, cardiovascular
Time frame: 28 days
Changes from baseline in C Reactive protein if available on V2, V3, V4, V5, and V6
Indicates improvement or worsening of inflammation.
Time frame: 28 days
Changes from baseline in Ferritin leves if available on V2, V3, V4, V5, and V6
Indicates improvement or worsening of inflammation.
Time frame: 28 days
Changes from baseline in Troponin leves if available on V2, V3, V4, V5, and V6
Indicates potential myocardial involvement.
Time frame: 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
Time frame: 28 days
Changes from baseline in creatinine leves if available on V2, V3, V4, V5, and V6
Indicates improvement or worsening of renal function
Time frame: 28 days
Changes from baseline in blilirrubin leves if available on V2, V3, V4, V5, and V6
Indicates improvement or worsening of liver function
Time frame: 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
Time frame: 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
Time frame: 28 days
Plan to share: Undecided
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Clinica Universidad de Navarra, Universidad de Navarra