Methods |
Trial design: open‐label RCT Sample size: 2000 Setting: outpatient Language: Dutch, English Number of centres: no information Type of intervention (treatment/prevention): treatment |
Participants |
Inclusion criteria
Age ≥ 18 years
A positive test for SARS‐CoV‐2
GP consultation for deteriorating COVID‐19 symptoms
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Additional inclusion criteria in order to be eligible for randomisation to the trial:
Exercise‐induced desaturation, defined as SpO2 < 92% (< 90% for COPD patients) and/or an absolute drop of ≥ 4% in SpO2 after a 1‐min sit‐to‐stand test OR
SpO2 < 92% (< 90% for COPD patients) at rest with GP's and patient's shared decision to keep patient at home despite this in itself being an indication for referral to hospital
Exclusion criteria
Inability to understand and sign the written consent form
Inability to perform saturation measurements or sit‐to‐stand test
Not willing to be admitted to hospital
On the discretion of the recruiting clinician if he or she deems a patient not eligible
Contra‐indication for dexamethasone
|
Interventions |
Details of intervention:
Treatment details of control group (e.g. dose, route of administration): only remote monitoring Concomitant therapy: no information |
Outcomes |
Primary outcome: time to first hospital admission or death (time frame: 28 days) |
Notes |
Recruitment status: terminated (too few patients) Prospective completion date: March 2022 Date last update was posted: 5 April 2021 Sponsor/funding: General Practitioners Research Institute |