- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04244591
Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure
Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
COVID-19 is a novel coronavirus that was initially outbreak in Wuhan, China. Severe acute respiratory infection with COVID-19 causes severe acute respiratory failure with substantial mortality. Currently, the standard care is supportive care, and no treatment is proven to be effective for this condition.
Glucocorticoid therapy is widely used among critically ill patients with other coronavirus infection such as SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). However, whether glucocorticoid improved the outcome of COVID-19 remains unknown. We hypothesized that glucocorticoid would improve the prognosis of patietns with COVID-19.
In this study, critically ill patients with COVID-19 were enrolled and randomized to receive ether standard care or standard care in combination with methylprednisolone therapy. The primary outcome is the difference of Murray lung injury score between two groups.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
-
-
Beijing
-
Beijing, Beijing, Kina, 010
- Medical ICU,Peking Union Medical College Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adult
- PCR confirmed COVID-19 infection
- Symptoms developed more than 7 days
- PaO2/FiO2 < 200 mmHg
- Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) higher than 45 L/min for less than 48 hours
- Requiring ICU admission
Exclusion Criteria:
- pregnancy;
- patients currently taking corticosteroids (cumulative 400 mg prednisone or equivalent);
- Severe underlying disease, i.e. end stage of malignancy disease or end stage of pulmonary disease;
- Severe adverse events before ICU admission, i.e. cardiac arrest;
- Underlying disease requiring corticosteroids;
- Contraindication for corticosteroids;
- Recruited in other clinical intervention trial
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: standard care
|
Standardvård
|
Experimentell: standard care + methylprednisolone therapy
Methylprednisolone 40 mg q12h for 5 days
|
Methylprednisolone 40 mg q12h for 5 days
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Lower Murray lung injury score
Tidsram: 7 days after randomization
|
Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.
|
7 days after randomization
|
Lower Murray lung injury score
Tidsram: 14 days after randomization
|
Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition.
|
14 days after randomization
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The difference of PaO2/FiO2 between two groups
Tidsram: 7 days after randomization
|
PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
|
7 days after randomization
|
Lower Sequential Organ Failure Assessment (SOFA) score
Tidsram: 7 days after randomization
|
Lower SOFA score means better outcome.
The SOFA score system range from 0 to 24 according to the severity of the condition.
|
7 days after randomization
|
Mechanical ventilation support
Tidsram: 7 days after randomization
|
Percentage of patients requiring Mechanical ventilation support
|
7 days after randomization
|
The difference of PaO2/FiO2 between two groups
Tidsram: 14 days after randomization
|
PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
|
14 days after randomization
|
Lower Sequential Organ Failure Assessment (SOFA) score
Tidsram: 14 days after randomization
|
Lower SOFA score means better outcome.
The SOFA score system range from 0 to 24 according to the severity of the condition.
|
14 days after randomization
|
Mechanical ventilation support
Tidsram: 14 days after randomization
|
Percentage of patients requiring Mechanical ventilation support
|
14 days after randomization
|
Clearance of noval coronavirus
Tidsram: 14 days after randomization
|
Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
|
14 days after randomization
|
All-cause mortality
Tidsram: 30 days after randomization
|
All-cause mortality
|
30 days after randomization
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Allmänna publikationer
- Arabi YM, Mandourah Y, Al-Hameed F, Sindi AA, Almekhlafi GA, Hussein MA, Jose J, Pinto R, Al-Omari A, Kharaba A, Almotairi A, Al Khatib K, Alraddadi B, Shalhoub S, Abdulmomen A, Qushmaq I, Mady A, Solaiman O, Al-Aithan AM, Al-Raddadi R, Ragab A, Balkhy HH, Al Harthy A, Deeb AM, Al Mutairi H, Al-Dawood A, Merson L, Hayden FG, Fowler RA; Saudi Critical Care Trial Group. Corticosteroid Therapy for Critically Ill Patients with Middle East Respiratory Syndrome. Am J Respir Crit Care Med. 2018 Mar 15;197(6):757-767. doi: 10.1164/rccm.201706-1172OC.
- Auyeung TW, Lee JS, Lai WK, Choi CH, Lee HK, Lee JS, Li PC, Lok KH, Ng YY, Wong WM, Yeung YM. The use of corticosteroid as treatment in SARS was associated with adverse outcomes: a retrospective cohort study. J Infect. 2005 Aug;51(2):98-102. doi: 10.1016/j.jinf.2004.09.008.
- Raghavendran K, Napolitano LM. Definition of ALI/ARDS. Crit Care Clin. 2011 Jul;27(3):429-37. doi: 10.1016/j.ccc.2011.05.006.
- Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.
- Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020.
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
Ytterligare relevanta MeSH-villkor
- Coronavirusinfektioner
- Coronaviridae-infektioner
- Nidovirales infektioner
- RNA-virusinfektioner
- Virussjukdomar
- Luftvägsinfektioner
- Luftvägssjukdomar
- Lunginflammation, Viral
- Lunginflammation
- Lungsjukdomar
- Covid-19
- Infektioner
- Läkemedels fysiologiska effekter
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Antiinflammatoriska medel
- Antineoplastiska medel
- Antiemetika
- Gastrointestinala medel
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Antineoplastiska medel, hormonella
- Neuroprotektiva medel
- Skyddsmedel
- Prednisolon
- Metylprednisolonacetat
- Metylprednisolon
- Metylprednisolonhemisuccinat
- Prednisolonacetat
- Prednisolonhemisuccinat
- Prednisolonfosfat
Andra studie-ID-nummer
- Glucocorticoid COVID-19
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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