Patients with COVID-19 related CRS treated with immunosuppressive treatment have better clinical outcomes compared to patients treated according to standard care.
ID
Bron
Verkorte titel
Aandoening
COVID-19 pneumonia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Time to clinical improvement: defined as the time from start of immunosuppressive treatment to improvement of at least 2 points on an ordinal scale 1-7 or hospital discharge, whichever comes first. This endpoint is recommended by WHO and used as the primary endpoint in the Lopinavir-Ritonavir trial. (17) The ordinal scale categories are: 1) non-hospitalized, able to resume normal activities; 2) non-hospitalized, but unable to resume normal activities; 3) hospitalized, not requiring oxygen therapy; 4) hospitalized, requiring additional oxygen therapy; 5) hospitalized, requiring high-flow nasal oxygen therapy, non-invasive mechanical ventilation, or both; 6) hospitalized, requiring ECMO, mechanical ventilation, or both; and 7) death.
Achtergrond van het onderzoek
Patients diagnosed with COVID-19 and severe pulmonary involvement (COVID-19 pneumonia; CORADS >=4) who present to the emergency department with compromised respiratory status (O2 requirement) are screened for treatment protocol. A CRS is deemed to exist if at least two of the following three criteria are met: CRP>100; Ferritin>900, D-Dimers>1500. After informed consent, patients are treated with methylprednisolone (MP) receive 250mg bolus intravenously, followed by at least 4 days MP 1mg/kg body weight iv (bolus). If the clinical situation deteriorates or does not improve after 48 hours, a single tocilizumab (8mg/kg body weight) is added.
Patients are monitored daily in a 24/7 multidisciplinary consultation responsible for treatment decisions, with emphasis on immunosuppressive regime and optimal anticoagulation.
Outcome measures are collected up to 6 months after admission: mortality, discharge, ICU admission, respiratory status (including oxygen support) and 3- and 6-month functionality and QoL.
The results of this cohort study will be compared with the results of age-gender and prognostic factor-matched control patients with COVID-19 pneumonia from before the start date of the protocol (1-4-2020). This concerns more than 400 patients.
Doel van het onderzoek
Patients with COVID-19 related CRS treated with immunosuppressive treatment have better clinical outcomes compared to patients treated according to standard care.
Onderzoeksopzet
3, 5, 7, 10, 14, 28 days and 3 and 6 months
Onderzoeksproduct en/of interventie
Methylprednisolone, eventually supplemented by tocilizumab
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Eligibility for immunosuppressive treatment is based on the Zuyderland treatment protocol (named; ‘Standpunt werkwijze behandeling COVID Zuyderland’, due to frequent updates will the most recent version be leading at any time).
According to Zuyderland treatment protocol version from 01.04.2020, this means:
1. Detection of diffuse interstitial pneumonia or bilateral infiltrations on chest x-ray or CO-RADS score ≥4 based on CT-thorax findings
2. Oxygen saturation at rest in ambient air ≤ 94% or tachypnea ≥30/min.
3. Presence of at least 2 of the following risk factors for CRS
a. High ferritin (> 900 ug/L or two times the level at admission within 48 hours)
b. High C-reactive protein (> 100 mg/L)
c. High D-dimer (> 1500 ug/L)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
No specific exclusion criteria
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8551 |
| Ander register | Bureau Wetenschappelijk Onderzoek Zuyderland Medical Center : Z2020077 |