Corona Virus Infection, Covid19
Conditions
Brief summary
The COVID-19 coronavirus has led to a global pandemic of respiratory diseases with an increase in hospitalization and death risk. To keep COVID-19 manageable for healthcare, early treatment is urgently needed to avoid hospitalization. Dexamethasone can dampen the exaggerated cytokine response to COVID-19 and is a promising agent for preventing disease aggravation, hospitalization and death. However, the evidence on the effectiveness, safety and cost-effectiveness of dexamethasone treatment in primary care is inconclusive.
Interventions
DRUGDexamethasone
6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms
Sponsors
Huisartsenzorg Drenthe
General Practitioners Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * A positive test for SARS-CoV-2 * A GP consultation for deteriorating COVID-19 symptoms Additional inclusion criteria in order to be eligible for randomization 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-minute sit-to-stand test OR \- SpO2\<92% (\<90% for COPD patients) in 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 The following criterion will be used to exclude patients from randomization to the trial: * Contra-indication for dexamethasone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization/death | 28 days | Time to first hospital admission or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recovery | 28 days | To assess the effectiveness of early treatment with dexamethasone in reducing time to recovery inpatients who are carefully monitored by their GP after a consultation for deteriorating COVID-19 |
| Disease severity | 28 days | To assess the effectiveness of early treatment with dexamethasone in reducing COVID-19 disease severity in patients who are remotely monitored by their GP after a consultation for deteriorating symptoms |
| HCRU | 28 days | To assess the effectiveness of the intervention in reducing healthcare resource utilization (HCRU) |
Countries
Netherlands
Outcome results
None listed