COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study

Study Overview
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Brief Summary
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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.

Official Title
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COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study: an Open-label Randomized Controlled Trial

Conditions
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Covid19, Corona Virus Infection

Intervention / Treatment
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* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms | Drug: Dexamethasone<br>* 6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms<br>|
| No Intervention: Control<br>Only remote monitoring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization/death | Time to first hospital admission or death | 28 days | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |