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

• Status: Terminated
• Trial end date: 2021-04-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: General Practitioners Research Institute
• Collaborator: Huisartsenzorg Drenthe
• Treatments: Dexamethasone

Criteria

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