Back to resultsCOVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study (COPPER)
Primary Purpose
Covid19, Corona Virus Infection
Status
Terminated
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility 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
Sites / Locations
- GPRI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms
Only remote monitoring
Outcomes
Primary Outcome Measures
Hospitalization/death
Time to first hospital admission or death
Secondary Outcome Measures
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
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
HCRU
To assess the effectiveness of the intervention in reducing healthcare resource utilization (HCRU)
Full Information
NCT ID
NCT04746430
First Posted
February 8, 2021
Last Updated
May 7, 2021
Sponsor
General Practitioners Research Institute
Collaborators
Huisartsenzorg Drenthe
1. Study Identification
Unique Protocol Identification Number
NCT04746430
Brief Title
COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study
Acronym
COPPER
Official Title
COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study: an Open-label Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Too few patients
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
April 23, 2021 (Actual)
Study Completion Date
April 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Practitioners Research Institute
Collaborators
Huisartsenzorg Drenthe
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Corona Virus Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms
Arm Title
Control
Arm Type
No Intervention
Arm Description
Only remote monitoring
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms
Primary Outcome Measure Information:
Title
Hospitalization/death
Description
Time to first hospital admission or death
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Recovery
Description
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
Time Frame
28 days
Title
Disease severity
Description
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
Time Frame
28 days
Title
HCRU
Description
To assess the effectiveness of the intervention in reducing healthcare resource utilization (HCRU)
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janwillem Kocks, Prof
Organizational Affiliation
General Practitioners Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
GPRI
City
Groningen
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study
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