Study on the Use of Sarilumab in Patients With COVID-19 Infection
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|ClinicalTrials.gov Identifier: NCT04386239|
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : July 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID19||Drug: Sarilumab Prefilled Syringe||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Monocentric, escalation dose|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study on the Use of Sarilumab in Patients With COVID-19 Infection|
|Actual Study Start Date :||January 1, 2021|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Patients with documented (chest X-Ray or Computed Tomography scan) Covid-19 (Polymerase Chain Reaction+ swab test) interstitial pneumonia and BCRSS ≥3 and <4 will be requested consent to the study.
Drug: Sarilumab Prefilled Syringe
Sarilumab administration must be associated with an antiviral treatment as defined by the treatment protocol suggested by the SIMET Experts group 4 and AIFA recommendations: chloroquine 500 mg 1 tablet twice daily or hydroxychloroquine 400 mg 1 tablet twice daily in the first day and then 200 mg 1 tablet twice daily.
Other Name: Sarilumab
- Proportion of patients who show an improvement of the respiratory function [ Time Frame: 6 weeks ]Clinical efficacy of sarilumab in adult patients hospitalized due to severe Covid-19 pneumonia based on the proportion of patients who show an improvement of the respiratory function, described as ≥30% decrease in oxygen requirement compared to baseline (as defined as the ratio of O2 flow through the Venturi mask).
- Evaluation of the time to resolution of fever [ Time Frame: 6 weeks ]Evaluation of the time to resolution of fever, defined as body temperature ≤36.6°C axilla, ≤37.8°C rectal or tympanic for at least 48 hours without antipyretics in patients with fever at baseline.
- Evaluation of the viral load on blood and sputum for COVID-19 [ Time Frame: Before administration of sarilumab, 48 hours and 96 hours after administration ]Evaluation of the viral load on blood and sputum for COVID-19
- Evaluation of the plasma concentration of GM-CSF [ Time Frame: Pre-treatment and 96 and 120 hours post-treatment ]Evaluation of the plasma concentration of GM-CSF
- Evaluation of the plasma concentration of Il-6 [ Time Frame: Pre-treatment and 96 and 120 hours post-treatment ]Evaluation of the plasma concentration of Il-6
- Evaluation of the plasma concentration of TNF-α [ Time Frame: Pre-treatment and 96 and 120 hours post-treatment ]Evaluation of the plasma concentration of TNF-α
- Evaluation of the rate of progression of White Blood Cell (WBC) fraction [ Time Frame: 96 and 120 hours post-treatment ]Evaluation of the rate of progression of WBC fraction of immature granulocytes - IG - (absolute count).
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): NCT04386239
|Contact: Agostino Riva, MDfirstname.lastname@example.org|
|Contact: Massimo Galli, Professoremail@example.com|
|Divisione Clinicizzata di Malattie Infettive, ASST FBF-Sacco||Recruiting|
|Milano, MI, Italy, 20157|
|Contact: Agostino Riva, M.D. 00390239042676 firstname.lastname@example.org|
|Principal Investigator:||Massimo Galli, Professor||University of Milan|