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

Phase 4

Terminated

• Conditions: Corona Virus Infection; Covid19
• Interventions: Drug: Dexamethasone

• Registration Number: NCT04746430
• Lead Sponsor: General Practitioners Research Institute

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-09
• Study Start: 2021-02-16
• Primary Completion: 2021-04-23
• Study Completion: 2021-04-23
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-07
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Dexamethasone	6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms

Primary Outcome Measures

Name	Time	Method
Hospitalization/death	28 days	Time to first hospital admission or death

Secondary Outcome Measures

Name	Time	Method
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)
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

Trial Locations

Locations (1)

GPRI; 🇳🇱 Groningen, Netherlands