Patients with COVID-19 and hypoxaemic respiratory failure and admitted to the intensive care unit (ICU) are treated with supplementary oxygen as a standard. However, quality of quantity evidence regarding this practise is low. The aim of the HOT-COVID trial is to evaluate the benefits and harms of two targets of partial pressure of oxygen in arterial blood (PaO2) in guiding the oxygen therapy in acutely ill adult COVID-19 patients with hypoxaemic respiratory failure at ICU admission.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Acutely admitted to the ICU AND
* Aged ≥ 18 years AND
* Receives supplemental oxygen with a flow of at least 10 L per minutes in an open system including high-flow systems OR recieves supplemental oxygen in a closed system including invasive or non-invasive ventilation or continuous positive airway pressure (CPAP)-systems AND
* Expected to receive supplemental oxygen for at least 24 hours in the ICU AND
* Having an arterial line for PaO2 monitoring AND
* Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (COVID-19) in the time leading to or during current hospital admission
Exclusion Criteria:
* Cannot be randomised within twelve hours after present ICU admission
* Chronic mechanical ventilation for any reason
* Use of home oxygen
* Previous treatment with bleomycin
* Organ transplant during current hospital admission
* Withdrawal from active therapy or brain death deemed imminent
* Fertile woman (\< 50 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG
* Carbon monoxide poisoning
* Cyanide poisoning
* Methaemoglobinaemia
* Paraquat poisoning
* Any condition expected to involve the use of hyperbaric oxygen (HBO)
* Sickle cell disease
* Consent not obtainable according to national regulations
* Previously randomised into the HOT-COVID trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared different oxygen targets in COVID-19 patients with low oxygen levels — can you explain what 'oxygen toxicity' means in this context, and whether the level of oxygen I'm receiving right now could be a concern?
2Since this was a Phase 4 trial that has already completed, has the results data been published, and if so, what did it find about survival and avoiding organ support at different oxygen targets?
3The trial measured 'days alive without organ support' as its main outcome — what does that mean practically for someone in my situation, and how does it relate to outcomes I should be hoping for?
4Are there any findings from this trial that have changed how your team sets oxygen levels for COVID-19 patients with breathing failure, or is standard practice still the same as before this study?
5Given that this trial is now completed, is there a newer or ongoing study on oxygen management in COVID-19 respiratory failure that might be worth considering, or is standard care now the recommended path for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.