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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000235-30 | EudraCT Number |
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Too few patients
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| Name | Class |
|---|---|
| Huisartsenzorg Drenthe | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms |
|
| Control | No Intervention | Only remote monitoring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization/death | Time to first hospital admission or death | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery | 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 | 28 days |
| Disease severity |
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Inclusion Criteria:
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:
The following criterion will be used to exclude patients from randomization to the trial:
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| Name | Affiliation | Role |
|---|---|---|
| Janwillem Kocks, Prof | General Practitioners Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GPRI | Groningen | Netherlands |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Randomized controlled trial
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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
| 28 days |
| HCRU | To assess the effectiveness of the intervention in reducing healthcare resource utilization (HCRU) | 28 days |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |