Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan
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Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan. / Petersen, Marie Warrer; Meyhoff, Tine Sylvest; Helleberg, Marie; Kjaer, Maj-Brit Norregaard; Granholm, Anders; Hjortso, Carl Johan Steensen; Jensen, Thomas Steen; Moller, Morten Hylander; Hjortrup, Peter Buhl; Wetterslev, Mik; Vesterlund, Gitte Kingo; Russell, Lene; Jorgensen, Vibeke Lind; Tjelle, Klaus; Benfield, Thomas; Ulrik, Charlotte Suppli; Andreasen, Anne Sofie; Mohr, Thomas; Bestle, Morten H.; Poulsen, Lone Musaeus; Hitz, Mette Friberg; Hildebrandt, Thomas; Knudsen, Lene Surland; Moller, Anders; Solling, Christoffer Grant; Brochner, Anne Craveiro; Rasmussen, Bodil Steen; Nielsen, Henrik; Christensen, Steffen; Strom, Thomas; Cronhjort, Maria; Wahlin, Rebecka Rubenson; Jakob, Stephan; Cioccari, Luca; Venkatesh, Balasubramanian; Hammond, Naomi; Jha, Vivekanand; Myatra, Sheila Nainan; Gluud, Christian; Lange, Theis; Perner, Anders.
In: Acta Anaesthesiologica Scandinavica, Vol. 64, No. 9, 2020, p. 1365-1375.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Low-dose hydrocortisone in patients with COVID-19 and severe hypoxia (COVID STEROID) trial-Protocol and statistical analysis plan
AU - Petersen, Marie Warrer
AU - Meyhoff, Tine Sylvest
AU - Helleberg, Marie
AU - Kjaer, Maj-Brit Norregaard
AU - Granholm, Anders
AU - Hjortso, Carl Johan Steensen
AU - Jensen, Thomas Steen
AU - Moller, Morten Hylander
AU - Hjortrup, Peter Buhl
AU - Wetterslev, Mik
AU - Vesterlund, Gitte Kingo
AU - Russell, Lene
AU - Jorgensen, Vibeke Lind
AU - Tjelle, Klaus
AU - Benfield, Thomas
AU - Ulrik, Charlotte Suppli
AU - Andreasen, Anne Sofie
AU - Mohr, Thomas
AU - Bestle, Morten H.
AU - Poulsen, Lone Musaeus
AU - Hitz, Mette Friberg
AU - Hildebrandt, Thomas
AU - Knudsen, Lene Surland
AU - Moller, Anders
AU - Solling, Christoffer Grant
AU - Brochner, Anne Craveiro
AU - Rasmussen, Bodil Steen
AU - Nielsen, Henrik
AU - Christensen, Steffen
AU - Strom, Thomas
AU - Cronhjort, Maria
AU - Wahlin, Rebecka Rubenson
AU - Jakob, Stephan
AU - Cioccari, Luca
AU - Venkatesh, Balasubramanian
AU - Hammond, Naomi
AU - Jha, Vivekanand
AU - Myatra, Sheila Nainan
AU - Gluud, Christian
AU - Lange, Theis
AU - Perner, Anders
PY - 2020
Y1 - 2020
N2 - Introduction Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists. Methods The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving >= 10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals. Discussion The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.
AB - Introduction Severe acute respiratory syndrome coronavirus-2 has caused a pandemic of coronavirus disease (COVID-19) with many patients developing hypoxic respiratory failure. Corticosteroids reduce the time on mechanical ventilation, length of stay in the intensive care unit and potentially also mortality in similar patient populations. However, corticosteroids have undesirable effects, including longer time to viral clearance. Clinical equipoise on the use of corticosteroids for COVID-19 exists. Methods The COVID STEROID trial is an international, randomised, stratified, blinded clinical trial. We will allocate 1000 adult patients with COVID-19 receiving >= 10 L/min of oxygen or on mechanical ventilation to intravenous hydrocortisone 200 mg daily vs placebo (0.9% saline) for 7 days. The primary outcome is days alive without life support (ie mechanical ventilation, circulatory support, and renal replacement therapy) at day 28. Secondary outcomes are serious adverse reactions at day 14; days alive without life support at day 90; days alive and out of hospital at day 90; all-cause mortality at day 28, day 90, and 1 year; and health-related quality of life at 1 year. We will conduct the statistical analyses according to this protocol, including interim analyses for every 250 patients followed for 28 days. The primary outcome will be compared using the Kryger Jensen and Lange test in the intention to treat population and reported as differences in means and medians with 95% confidence intervals. Discussion The COVID STEROID trial will provide important evidence to guide the use of corticosteroids in COVID-19 and severe hypoxia.
KW - THERAPY
U2 - 10.1111/aas.13673
DO - 10.1111/aas.13673
M3 - Journal article
C2 - 32779728
VL - 64
SP - 1365
EP - 1375
JO - Acta Anaesthesiologica Scandinavica
JF - Acta Anaesthesiologica Scandinavica
SN - 0001-5172
IS - 9
ER -
ID: 246779579