Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID-19 Pneumonia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04329650|
Recruitment Status : Unknown
Verified April 2020 by Judit Pich Martínez, Fundacion Clinic per a la Recerca Biomédica.
Recruitment status was: Recruiting
First Posted : April 1, 2020
Last Update Posted : April 17, 2020
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Siltuximab Drug: Methylprednisolone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2, Randomized, Open-label Study to Compare Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID19 Pneumonia|
|Actual Study Start Date :||April 15, 2020|
|Estimated Primary Completion Date :||May 20, 2020|
|Estimated Study Completion Date :||May 20, 2020|
|Experimental: Siltuximab 11mg/Kg||
A single-dose of 11mg/Kg of siltuximab will be administered by intravenous infusion.
|Active Comparator: Methylprednisolone 250mg/24h||
A dose of 250mg/24 hours of methylprednisolone during 3 days followed by 30mg/24 hours during 3 days will be administered by intravenous infusion.
If the patient is taken lopinavir/ritonavir, the dose will be 125 mg/ 24 hours during 3 days followed by 15mg/24 hours during 3 days.
- Proportion of patients requiring ICU admission at any time within the study period. [ Time Frame: 29 days ]
- Days of stay in the ICU during the study period. [ Time Frame: 29 days ]
- Days until resolution of fever defined as body temperature (axillary ≤ 36.6 ° C, oral ≤ 37.2 ° C, or rectal or tympanic ≤ 37.8 ° C) for at least 48 hours, without administration of antipyretics or until hospital discharge. [ Time Frame: 29 days ]
- Proportion of patients with a worsening requirement of supplemental oxygen at 29 days. days. [ Time Frame: 29 days ]
- Days with hypoxemia (SpO2 <93% in ambient air or requiring oxygen supplemental or mechanical ventilation support) at 29 days. [ Time Frame: 29 days ]
- Proportion of patients using mechanical ventilation at 29 days. [ Time Frame: 29 days ]
- Days with use of mechanical ventilation at 29 days. [ Time Frame: 29 days ]
- Days until the start of use of mechanical ventilation, non-invasive ventilation or use of high flow nasal cannula (if the patient have not previously required these interventions at the inclusion of the study) at 29 days. [ Time Frame: 29 days ]
- Days of hospitalization among survivors at 29 days. [ Time Frame: 29 days ]
- Mortality rate from any cause at 29 days. [ Time Frame: 29 days ]
- Proportion of patients with serious adverse events at 29 days. [ Time Frame: 29 days ]
- Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic with grade 4 neutropenia (count neutrophil absolute <500 / mm3) at 29 days. [ Time Frame: 29 days ]
- Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic at 29 days. [ Time Frame: 29 days ]
- Proportion of patients with grade 2 or higher adverse reactions related to the infusion of the sudy treatments at 29 days. [ Time Frame: 29 days ]
- Proportion of patients with hypersensitivity reactions of grade 2 or higher related to the administration of the study treatments at 29 days. [ Time Frame: 29 days ]
- Proportion of patients with gastrointestinal perforation at 29 days. [ Time Frame: 29 days ]
- Proportion of patients with secondary severe infections confirmed by laboratory or worsening of existing infections at 29 days. [ Time Frame: 29 days ]
- Changes from baseline in plasma leukocyte levels at days 1, 3, 5, 7 and 9. [ Time Frame: Days 1, 3, 5, 7 and 9 ]
- Changes from baseline in plasma hemoglobin levels at days 1, 3, 5, 7 and 9. [ Time Frame: Days 1, 3, 5, 7 and 9 ]
- Changes from baseline in plasma platelet at days 1, 3, 5, 7 and 9. [ Time Frame: Days 1, 3, 5, 7 and 9 ]
- Changes from baseline in plasma creatinine levels at days 1, 3, 5, 7 and 9. [ Time Frame: Days 1, 3, 5, 7 and 9 ]
- Changes from baseline in plasma total bilirubin levels at days 1, 3, 5, 7 and 9. [ Time Frame: Days 1, 3, 5, 7 and 9 ]
- Proportion of patients with ALT≥ 3 times ULN (for patients with initial values normal) or> 3 times ULN AND at least 2 times more than the initial value (for patients with abnormal initial values) at days 1, 3, 5, 7 and 9. [ Time Frame: Days 1, 3, 5, 7 and 9 ]
- Changes from baseline in plasma biomarkers (PCR, lymphocytes, ferritin, d-dimer and LDH) at days 1, 3, 5, 7 and 9. [ Time Frame: Days 1, 3, 5, 7 and 9 ]
- Changes from baseline in chest Rx at days 1, 3 and 5. [ Time Frame: Days 1, 3 and 5 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age ≥ 18 years old.
Hospitalized patient (or documentation of a hospitalization plan if the patient is in an emergency department) with illness of more than 5 days of duration with evidence of pneumonia by chest radiography / tomography computed chest and meets at least one of the following requirements:
- Non-critical patient with pneumonia in radiological progression and / or
- Patient with progressive respiratory failure at the last 24-48 hours.
- Laboratory confirmed SARS-CoV-2 infection (by PCR) or other commercialized analysis or public health in any sample collected 4 days before the randomization or COVID-19 criteria following the defined diagnostic criteria at that time in the center.
- Patient with a maximum O2 support of 35%
- Be willing and able to comply with the study related procedures / evaluations.
- Women of childbearing potential * should have a negative serum pregnancy test before enrollment in the study and must commit to using methods highly effective contraceptives (intrauterine device, bilateral tubal occlusion, vasectomized couple and sexual abstinence).
- Written informed consent. In case of inability of the patient to sign the informed consent, a verbal informed consent from the legal representative or family witness (or failing this, an impartial witness outside the investigator team) will be obtained by phone.
When circumstances so allow, participants should sign the consent form. The confirmation of the verbal informed consent will be documented in a document as evidence that verbal consent has been obtained.
- Patient who, in the investigator's opinion, is unlikely to survive> 48 hours after the inclusion in the study.
Presence of any of the following abnormal analytical values at the time of the inclusion in the study:
- absolute neutrophil count less than 2000 / mm3;
- AST or ALT> 5 times the upper limit of normality;
- platelets <50,000 per mm3.
- In active treatment with immunosuppressants or previous prolonged treatment (more 3 months) of oral corticosteroids for a disease not related to COVID-19 at a dose greater than 10 mg of prednisone or equivalent per day.
- Known active tuberculosis or known history of tuberculosis uncompleted treatment.
- Patients with active systemic bacterial and / or fungal infections.
- Patients who have received previous treatment with IL6 inhibitor (tocilizumab, sarilumab).
- Participants who, at the investigator's discretion, are not eligible to participate, regardless of the reason, including medical or clinical conditions, or participants potentially at risk of not following study procedures.
- Patients who do not have entry criteria in the Intensive Care Unit.
- Pregnancy or lactation.
- Known hypersensitivity to siltuximab or to any of its excipients (histidine, histidine hydrochloride, polysorbate 80 and sucrose).
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): NCT04329650
|Contact: Felipe García, MD||+34932275400 ext email@example.com|
|Hospital Germans Trias i Pujol||Not yet recruiting|
|Contact: Roger Paredes, MD|
|Principal Investigator: Roger Paredes, MD|
|Hospital Clínic de Barcelona||Recruiting|
|Barcelona, Spain, 08036|
|Contact: Felipe García, MD|
|Principal Investigator: Felipe García, MD|
|Principal Investigator: Alex Soriano, MD|
|Hospital Universitario de Salamanca||Not yet recruiting|
|Contact: Cristina Carbonell, MD|
|Principal Investigator: Cristina Carbonell, MD|
|Hospital Universitari Mútua de Terrassa||Not yet recruiting|
|Contact: David Dalmau, MD|
|Principal Investigator: David Dalmau, MD|
|Principal Investigator:||Felipe García, MD||Hospital Clinic of Barcelona|
|Responsible Party:||Judit Pich Martínez, Clinical Research Manager, Fundacion Clinic per a la Recerca Biomédica|
|Other Study ID Numbers:||
|First Posted:||April 1, 2020 Key Record Dates|
|Last Update Posted:||April 17, 2020|
|Last Verified:||April 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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Hormones, Hormone Substitutes, and Hormone Antagonists