- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04893031
Effect of Tocilizumab on Intensive Care Patients With COVID-19 Pneumonia, a Retrospective Cohort Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
With this study, the investigators will evaluate the efficacy of Tocilizumab, an IL-6 antagonist administered in the early period in intensive care patients with COVID-19 pneumonia followed by hypoxic and systemic inflammation is predominant, but who do not support mechanical ventilation.
With this study, those with signs of hypoxia and systemic inflammation followed by COVID-19 pneumonia (SpO2 <90% on room air together with the elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrates on chest radiograph and tocilizumab the patients who received treatment and those who received standard therapy will be compared.
In the study, cases followed up with COVID-19 pneumonia and respiratory failure between March 2020 and March 2021 will be retrospectively evaluated. Tocilizumab was applied as 400 mg - 800 mg iv (depending on weight). A second dose could be given 12-24 h later if the patient's condition had not improved. Primary end point was determined as intensive care mortality.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Trabzon, Kalkon, 61080
- Karadeniz Technical University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- All patients were admitted to intensive care unit, diagnosed with COVID-19 pneumonia
Exclusion Criteria:
- Patients who require mechanical ventilation in intensive care admission
- Cases who received tocilizumab after being intubated during follow-up even though they were not intubated at admission
- patients for whom tocilizumab is contraindicated
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Tocilizumab treatment group
Symptoms of hypoxia and systemic inflammation (SpO2 <90% on room air with accompanying elevation of any two of the systemic inflammatory markers such as CRP, LDH and Ferritin) and / or acute bilateral infiltrations on chest radiography or rapid progression of existing infiltrations, but who did not need mechanical ventilation at admission and were given tocilizumab treatment.
|
400mg or 800 mg IV tocilizumab treatment according to patient clinical severity
|
Standard treatment group
Patients who did not require mechanical ventilation in intensive care admission and did not receive tocilizumab treatment during any period of hospitalization.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Rates of intensive care mortality in the groups
Tidsram: 28 Day
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all-cause mortality in the patient groups given and not given tocilizumab in the intensive care unit.
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28 Day
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Rates of needed of mechanical ventilation in the groups
Tidsram: 28 Day
|
Intubation in tocilizumab or standard therapy group assessed by an event-time analysis.
|
28 Day
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2021/24
- 2021-01-24T17_19_44 (Annan identifierare: Republic of Turkey Ministery of Health)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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