COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04655638

Andrea Cortegiani, MD

andrea.cortegiani@unipa.it

2020-12-07

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - age ≥ 18 years old - tested positive for sars-cov-2 using real-time reverse transcriptase pcr (rt-pcr) nasopharyngeal swabs - clinical signs of acute respiratory infection and radiological evidence of pneumonia - hospital admission in any ward or emergency department within 48 h - spo2 ≤ 92% or pao2/fio2 < 300 in room air and need for oxygen therapy according to clinical judgment, at the screening.

- pao2/fio2 ≤ 200 - respiratory rate ≥ 28 breaths/min and or severe dyspnea and or use of accessory muscles - need for immediate intubation or noninvasive ventilation (including cpap) according to clinical judgment (e.g. clinical diagnosis of cardiogenic pulmonary edema, respiratory acidosis ph ≤ 7.3) - patients already on cpap/niv or hfnt at study screening - septic shock - evidence of multiorgan failure - glasgow coma scale < 13 - inability to comprehend the study content and give informed consent - paco2 > 45 mmhg, (if blood gas available) or history of chronic hypercapnia - patient already on long-term oxygen therapy (ltot) or home niv/cpap (even if only overnight) - neuromuscular disease - limitation of care based on patients' or physicians' decision

2

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

18

100

Greece;Italy;Poland;Portugal;Spain;Turkey

Severe disease at enrollment

6: Severe disease at enrollment

364

Proportion of patients needing escalation of treatment during hospital stay

None

Not reported

[{"arm_notes": "", "treatment_id": 577, "treatment_name": "High flow nasal oxygen", "treatment_type": "Respiratory support", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]