Higher vs. Lower Doses of Dexamethasone for COVID-19 and Severe Hypoxia
NCT ID: NCT04509973
Last Updated: 2022-02-24
Study Results
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Basic Information
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COMPLETED
PHASE3
1000 participants
INTERVENTIONAL
2020-08-27
2022-02-01
Brief Summary
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Detailed Description
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Objective: We aim to assess the effects of higher (12 mg) vs lower doses (6 mg) of intravenous dexamethasone on the number of days alive without life-support in adult patients with COVID-19 and severe hypoxia.
Design: International, parallel-group, centrally randomised, stratified, blinded, clinical trial.
Population: Adult patients with documented COVID-19 receiving at least 10 L/min of oxygen independent of delivery system OR mechanical ventilation.
Experimental intervention: Dexamethasone 12 mg once daily for up to 10 days in addition to standard care.
Control intervention: Dexamethasone 6 mg once daily for up to 10 days in addition to standard care.
Outcomes: The primary outcome is days alive without life support (i.e. mechanical ventilation, circulatory support, or renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions (i.e. anaphylactic reaction to hydrocortisone, new episode of septic shock, invasive fungal infection or clinically important gastrointestinal bleeding) at day 28; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, 90 and 180; and health-related quality of life at day 180.
Sample size: A total of 1000 participants will be randomised in order to detect a 15% relative reduction in 28-day mortality combined with a 10% reduction in time on life support among the survivors with a power of 85%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexamethasone 12 mg
Intravenous bolus injection of dexamethasone 12 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 12 mg at sites, where dexamethasone is not available.
Dexamethasone
ATC code: H02AB02
Dexamethasone 6 mg
Intravenous bolus injection of dexamethasone 6 mg once daily in addition to standard care for up to 10 days. We will allow the use of betamethasone 6 mg at sites, where dexamethasone is not available.
Dexamethasone
ATC code: H02AB02
Interventions
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Dexamethasone
ATC code: H02AB02
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation AND
* Use of one of the following:
* Invasive mechanical ventilation OR
* Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR
* Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system
Exclusion Criteria
* Use of systemic corticosteroids for COVID-19 for 5 days consecutive days or more
* Invasive fungal infection
* Active tuberculosis
* Fertile woman (\<60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
* Known hypersensitivity to dexamethasone
* Previously randomised into the COVID STEROID 2 trial
* Informed consent not obtainable
18 Years
ALL
No
Sponsors
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Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Centre for Research in Intensive Care (CRIC)
OTHER
Aarhus University Hospital
OTHER
Aalborg University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
The George Institute for Global Health, Australia
OTHER
Scandinavian Critical Care Trials Group
OTHER
Responsible Party
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Locations
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Hvidovre Hospital - Dept of Infectious diseases
Hvidovre, , Denmark
Hvidovre Hospital - Dept of Intensive Care
Hvidovre, , Denmark
Hvidovre Hospital - Dept of Pulmonary Medicine
Hvidovre, , Denmark
Dept. of Anaesthesia and Intensive Care, Lillebaelt Hospital
Kolding, , Denmark
Dept. of Intensive Care, Køge University Hospital
Køge, , Denmark
Dept of Intensive Care, Odense University Hospital
Odense, , Denmark
Dept. of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark.
Aalborg, , Denmark
Dept. of Intensive care, Aarhus University Hospital
Aarhus, , Denmark
Dept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Dept. of Neuroanaesthesiology
Copenhagen, , Denmark
Dept. of Thoracic Anaesthesiology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Dept of Infectious diseases, Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Dept. of Intensive Care, Gentofte Hospital
Hellerup, , Denmark
Dept. of Anaesthesia and Intensive Care, Herlev Hospital
Herlev, , Denmark
Dept. of Anaesthesia, Regional Hospital West Jutland, Herning
Herning, , Denmark
Dept. of Intensive Care, Nordsjællands Hospital - Hillerød, Denmark.
Hillerød, , Denmark
Dept. of Anaesthesia and Intensive Care, Zealand University Hospital Roskilde
Roskilde, , Denmark
Dept. of Anaesthesia, Slagelse Hospital
Slagelse, , Denmark
Dept. of Anaesthesia and Intensive Care, Viborg Hospital
Viborg, , Denmark
Jawahar Lal Nehru Medical Collega, AMU
Aligarh, , India
Apollo Hospital
Chennai, , India
Amrita Institute of Medical Sciences
Kochi, , India
Bombay Hospital & Medical Research Centre
Mumbai, , India
K. J. Somaiya Super Specialty Hospital
Mumbai, , India
P. D. Hinduja National Hospital & Medical Research Centre
Mumbai, , India
S L Raheja Fortis Hospital
Mumbai, , India
Tata Memorial Hospital
Mumbai, , India
Wockhardt hospitals
Mumbai, , India
Indraprastha Apollo Hospital
New Delhi, , India
Max Super Specialty Hospital, Saket
New Delhi, , India
Symbiosis University Hospital and Research Centre
Pune, , India
Vishwaraj Hospital
Pune, , India
Rajendra Institute of Medical Sciences
Ranchi, , India
Gotri General Hospital
Vadodara, , India
Christian Medical College Vellore
Vellore, , India
Dept. of Anaesthesia and Intensive Care, Sahlgranska Universitetssjukhuset
Gothenburg, , Sweden
Dept. of Infectious Diseases, Sahlgranska Universitetssjukhuset
Gothenburg, , Sweden
Dept. of Anaesthesia and Intensive Care, Universitetssjukhuset i Linköping
Linköping, , Sweden
Dept. of Anaesthesia and Intensive Care, Skånes Universitetssjukhus (SUS) Malmö
Malmo, , Sweden
Dept. of Infectious Diseases, Skånes Universitetssjukhus (SUS) Malmö
Malmo, , Sweden
Dept. of Anaesthesia and Intensive Care, Vrinnevisjukhuset, Norrköping
Norrköping, , Sweden
Dept. of Anaesthesia and Intensive Care, Capio St Görans Sjukhus
Stockholm, , Sweden
Dept. of Anaesthesia and Intensive Care, Danderyds Sjukhuset
Stockholm, , Sweden
Dept. of Anaesthesia and Intensive Care, Karolinska Universitetssjukhuset, Huddinge
Stockholm, , Sweden
Dept. of Anaesthesia and Intensive Care, Karolinska Universitetssjukhuset, Solna
Stockholm, , Sweden
Dept. of Cardiology, Södersjukhuset
Stockholm, , Sweden
Dept. of Infectious Diseases, Danderyds Sjukhuset
Stockholm, , Sweden
Dept. of Infectious Diseases, Karolinska Universitetssjukhuset, Solna
Stockholm, , Sweden
Dept. of Infectious Diseases, Södersjukhuset
Stockholm, , Sweden
Dept. of Internal Medicine, Danderyds Sjukhuset
Stockholm, , Sweden
Dept. of Internal Medicine, Södersjukhuset
Stockholm, , Sweden
Södersjukhuset
Stockholm, , Sweden
Dept. of Intensive Care Medicine, Bern University Hospital (Inselspital)
Bern, , Switzerland
Countries
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References
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Granholm A, Kaas-Hansen BS, Lange T, Munch MW, Harhay MO, Zampieri FG, Perner A, Moller MH, Jensen AKG. Use of days alive without life support and similar count outcomes in randomised clinical trials - an overview and comparison of methodological choices and analysis methods. BMC Med Res Methodol. 2023 Jun 14;23(1):139. doi: 10.1186/s12874-023-01963-z.
Granholm A, Kjaer MN, Munch MW, Myatra SN, Vijayaraghavan BKT, Cronhjort M, Wahlin RR, Jakob SM, Cioccari L, Vesterlund GK, Meyhoff TS, Helleberg M, Moller MH, Benfield T, Venkatesh B, Hammond NE, Micallef S, Bassi A, John O, Jha V, Kristiansen KT, Ulrik CS, Jorgensen VL, Smitt M, Bestle MH, Andreasen AS, Poulsen LM, Rasmussen BS, Brochner AC, Strom T, Moller A, Khan MS, Padmanaban A, Divatia JV, Saseedharan S, Borawake K, Kapadia F, Dixit S, Chawla R, Shukla U, Amin P, Chew MS, Wamberg CA, Bose N, Shah MS, Darfelt IS, Gluud C, Lange T, Perner A. Long-term outcomes of dexamethasone 12 mg versus 6 mg in patients with COVID-19 and severe hypoxaemia. Intensive Care Med. 2022 May;48(5):580-589. doi: 10.1007/s00134-022-06677-2. Epub 2022 Mar 31.
Durr KM, Hendin A, Perry JJ. Effect of 12 mg vs 6 mg of dexamethasone on the number of days alive without life support in adults with COVID-19 and severe hypoxemia: the COVID STEROID 2 randomized trial. CJEM. 2022 Apr;24(3):266-267. doi: 10.1007/s43678-022-00293-1. Epub 2022 Mar 29. No abstract available.
Granholm A, Munch MW, Myatra SN, Vijayaraghavan BKT, Cronhjort M, Wahlin RR, Jakob SM, Cioccari L, Kjaer MN, Vesterlund GK, Meyhoff TS, Helleberg M, Moller MH, Benfield T, Venkatesh B, Hammond NE, Micallef S, Bassi A, John O, Jha V, Kristiansen KT, Ulrik CS, Jorgensen VL, Smitt M, Bestle MH, Andreasen AS, Poulsen LM, Rasmussen BS, Brochner AC, Strom T, Moller A, Khan MS, Padmanaban A, Divatia JV, Saseedharan S, Borawake K, Kapadia F, Dixit S, Chawla R, Shukla U, Amin P, Chew MS, Wamberg CA, Gluud C, Lange T, Perner A. Dexamethasone 12 mg versus 6 mg for patients with COVID-19 and severe hypoxaemia: a pre-planned, secondary Bayesian analysis of the COVID STEROID 2 trial. Intensive Care Med. 2022 Jan;48(1):45-55. doi: 10.1007/s00134-021-06573-1. Epub 2021 Nov 10.
COVID STEROID 2 Trial Group; Munch MW, Myatra SN, Vijayaraghavan BKT, Saseedharan S, Benfield T, Wahlin RR, Rasmussen BS, Andreasen AS, Poulsen LM, Cioccari L, Khan MS, Kapadia F, Divatia JV, Brochner AC, Bestle MH, Helleberg M, Michelsen J, Padmanaban A, Bose N, Moller A, Borawake K, Kristiansen KT, Shukla U, Chew MS, Dixit S, Ulrik CS, Amin PR, Chawla R, Wamberg CA, Shah MS, Darfelt IS, Jorgensen VL, Smitt M, Granholm A, Kjaer MN, Moller MH, Meyhoff TS, Vesterlund GK, Hammond NE, Micallef S, Bassi A, John O, Jha A, Cronhjort M, Jakob SM, Gluud C, Lange T, Kadam V, Marcussen KV, Hollenberg J, Hedman A, Nielsen H, Schjorring OL, Jensen MQ, Leistner JW, Jonassen TB, Kristensen CM, Clapp EC, Hjortso CJS, Jensen TS, Halstad LS, Bak ERB, Zaabalawi R, Metcalf-Clausen M, Abdi S, Hatley EV, Aksnes TS, Gleipner-Andersen E, Alarcon AF, Yamin G, Heymowski A, Berggren A, La Cour K, Weihe S, Pind AH, Engstrom J, Jha V, Venkatesh B, Perner A. Effect of 12 mg vs 6 mg of Dexamethasone on the Number of Days Alive Without Life Support in Adults With COVID-19 and Severe Hypoxemia: The COVID STEROID 2 Randomized Trial. JAMA. 2021 Nov 9;326(18):1807-1817. doi: 10.1001/jama.2021.18295.
Granholm A, Munch MW, Myatra SN, Vijayaraghavan BKT, Cronhjort M, Wahlin RR, Jakob SM, Cioccari L, Kjaer MN, Vesterlund GK, Meyhoff TS, Helleberg M, Moller MH, Benfield T, Venkatesh B, Hammond N, Micallef S, Bassi A, John O, Jha V, Kristiansen KT, Ulrik CS, Jorgensen VL, Smitt M, Bestle MH, Andreasen AS, Poulsen LM, Rasmussen BS, Brochner AC, Strom T, Moller A, Khan MS, Padmanaban A, Divatia JV, Saseedharan S, Borawake K, Kapadia F, Dixit S, Chawla R, Shukla U, Amin P, Chew MS, Gluud C, Lange T, Perner A. Higher vs Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia (COVID STEROID 2) trial: Protocol for a secondary Bayesian analysis. Acta Anaesthesiol Scand. 2021 May;65(5):702-710. doi: 10.1111/aas.13793. Epub 2021 Feb 25.
Related Links
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Trial website
Other Identifiers
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2020-003363-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2020-07-16
Identifier Type: OTHER
Identifier Source: secondary_id
H-20051056
Identifier Type: OTHER
Identifier Source: secondary_id
RH-ITA-009
Identifier Type: -
Identifier Source: org_study_id
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