NCT04344730.
Study name | Dexamethasone and oxygen support strategies in ICU patients with Covid‐19 pneumonia (COVIDICUS trial) |
Methods | RCT, 2 x 2 factorial design |
Participants | Estimated number of participants: 550 Setting: ICU, France Inclusion criteria: age ≥ 18 years; admitted to ICU within 48 hours; confirmed or highly suspected Covid‐19 infection; AHRF; any treatment intended to treat the SARS‐CoV‐2 infection (compassionate or in context of clinical trial) Exclusion criteria: moribund; pregnancy or breastfeeding; long‐term corticotherapy; active and untreated bacterial, fungal or parasitic infection; no written informed consent; hypersensitivity to dexamethasone; not affiliated to French social security; anatomical factors precluding use of nasal cannula; hypercapnia indicating NIV |
Interventions | Intervention group (HFNC): flow = 30 L/min; FiO2 adjusted to target SpO2 ≥ 92% Control group (NIV): CPAP; flow adjusted to target SpO2 ≥ 92% |
Outcomes | All outcomes measured: time‐to‐death; time‐to‐MV; viral load of SARS‐CoV‐2 in respiratory tract; healthcare‐associated infection rate; days alive without MV; SOFA score; days alive without renal replacement therapy; length of ICU stay; length of hospital stay; number of patients with severe hypoxaemia (SpO2 < 80%); cardiac arrest within 1 hour of intubation Outcomes relevant to this review: length of ICU stay; length of hospital stay; adverse event rate |
Starting date | 14 April 2020 |
Contact information | Jean François, jean‐françois.timsit@aphp.fr. Lila Bouadma, lila.bouadma@aphp.fr |
Notes |