Safety and Effectiveness Study of Tocilizumab in Patients With Severe COVID-19
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|ClinicalTrials.gov Identifier: NCT04924829|
Recruitment Status : Recruiting
First Posted : June 14, 2021
Last Update Posted : June 14, 2021
|Condition or disease||Intervention/treatment|
|Severe COVID 19 Pneumonia Tocilizumab||Drug: Tocilizumab|
Since the appearence of the disease today known as COVID-19 there has been multiple interventions to try to gain knowledge on the subject and obtain a benefitial effect treating this condition.
Tocilizumab, a monoclonal antibody targeting IL-6 receptor has arised as an alternative for the treament of COVID-19 pneumonia.
It is a drug used for the treatment of rhemautoid arthritis and other autoimmune diseases as well as approved in recent years for the treatment of the cytokine release syndrome (CRS) in CAR-T therapy.
It is based in this last premise that the benefitial effect on COVID-19 pneumonia has been sought of. According to investigation into the physiopathology of the virus, it is supposed to trigger the inflamattory cascade that generates damage to lungs and creates the most severe cases of the disease. These findings could imply that tocilizumab may serve to interrupt this cytokine storm and prevent the progression of the disease.
The aim of the study is to evaluate the effectiveness and safety of tocilizumab in the treatment of severe cases of COVID-19. For that purpose, an observational retrospective cohort study has been designed comparing two populations that share the same indication for the treatment with tocilizumab. One having received the drug and the other in a close previous period of time that has not received it because of lack of availability or generalisation of its use. Mortality will be assesed as well as other variables such as need for mechanical ventilation and adverse effects of tocilizumab.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Safety and Effectiveness Observational Study of Anti IL-6 Tocilizumab in Hospital Admitted Patients With Severe COVID-19 Pneumonia.|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||August 1, 2021|
Group that received tocilizumab (8mg/kg, maximum dose 800 mg, only once) while being admitted with severe COVID-19 pneumonia.
Tocilizumab received as a single intravenous infusion over the period of 60 minutes. Dose of 8 mg/kg, maximum dose of 800 mg.
Group that did not receive tocilizumab but share the same indication according to the elegibility criteria for it as the tocilizumab group while admitted with severe COVID-19 pneumonia.
- 28-day mortality [ Time Frame: 28 days from hospital admission ]28-day mortality
- Percentage of patients in invasive mechanical ventilation at day 28 [ Time Frame: 28 days from hospital admission ]Percentage of patients that received invasive mechanical ventilation at day 28 following hospital admission.
- Clinical status during follow-up at 28th day [ Time Frame: 28th day from hospital admission ]Ordinal outcome with seven mutually exclusive categories to describe the patient's clinical status during follow-up. The six categories are: (1) Discharged or ready for discharge; (2) Admitted to non-ICU ward without oxygen; (3) admitted to non-ICU ward but requiring supplemental oxygen; (4) admitted to ICU or non ICU ward requiring high flow nasal canula or other non invasive mechanical ventilation; (5) admitted to ICU ward requiring invasive mechanical ventilation (6) admitted to ICU ward requiring extracorporeal membrane oxygenation or invasive mechanical ventilation plus other vital organ support; (7) death
- Mortality rate [ Time Frame: Days 14 and 21 ]
- Percentage of patients in invasive mechanical ventilation at day 14 and 21 [ Time Frame: Days 14 and 21 ]
- Percentage of patients with hospital discharge at day 7, 14, 21 and 28 [ Time Frame: Days 7, 14, 21 and 28 ]
- Time to hospital discharge [ Time Frame: Up to 60 days ]Time from hospital admission to hospital discharge
- Percentage of patients admitted to ICU-ward at day 28 [ Time Frame: 28th day from hospital admission ]Percentage of patients admitted to ICU-ward at day 28 from hospital admission
- Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status [ Time Frame: Up to 60 days ]
- Percentage of patients with need of tracheostomy at day 28 of hospital admission [ Time Frame: 28th day from hospital admission ]
- Time to mechanical ventilation from hospital admission [ Time Frame: Up to 28 days ]
- Days of ICU admission [ Time Frame: Up to 60 days ]
- Time to ICU discharge from hospital admission [ Time Frame: Up to 60 days ]Time to ICU discharge from hospital admission in the patients subgroup that required ICU admission.
- Percentage of patients with adverse effects / serious adverse effects [ Time Frame: Up to 28 days ]
- Percentage of superimposed infections [ Time Frame: 28th day from hospital admission ]
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): NCT04924829
|Contact: Anaclara Murujosa, MDfirstname.lastname@example.org|
|Contact: Diego H Giunta, MD, MPH, PhD||+54 11 4959 0200 ext email@example.com|
|Hospital Italiano de Buenos AIres||Recruiting|
|Ciudad autónoma de Buenos Aires, Caba, Argentina, 1199|
|Contact: Anaclara Murujosa, MD +5491157033547 firstname.lastname@example.org|
|Contact: Diego Hernán Giunta, MD, MPH, University SoTL, PhD +54 11 4959 0200 ext 4806 email@example.com|