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Trial record 1 of 8 for:    COPPER | Covid19
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COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study (COPPER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04746430
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : April 5, 2021
Sponsor:
Collaborator:
Huisartsenzorg Drenthe
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Covid19 Corona Virus Infection Drug: Dexamethasone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study: an Open-label Randomized Controlled Trial
Actual Study Start Date : February 16, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : March 2022


Arm Intervention/treatment
Experimental: Intervention
6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms
Drug: Dexamethasone
6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms

No Intervention: Control
Only remote monitoring



Primary Outcome Measures :
  1. Hospitalization/death [ Time Frame: 28 days ]
    Time to first hospital admission or death


Secondary Outcome Measures :
  1. Recovery [ Time Frame: 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

  2. Disease severity [ Time Frame: 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

  3. HCRU [ Time Frame: 28 days ]
    To assess the effectiveness of the intervention in reducing healthcare resource utilization (HCRU)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04746430


Contacts
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Contact: Marten Harbers, PhD +31 (0)50 2113898 COPPER@gpri.nl

Locations
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Netherlands
GPRI Recruiting
Groningen, Netherlands
Contact: Janwillem Kocks    +31 (0)50 2113898    copper@gpri.nl   
Sponsors and Collaborators
General Practitioners Research Institute
Huisartsenzorg Drenthe
Investigators
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Principal Investigator: Janwillem Kocks, Prof General Practitioners Research Institute
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Responsible Party: General Practitioners Research Institute
ClinicalTrials.gov Identifier: NCT04746430    
Other Study ID Numbers: GPRI-21001-COV
2021-000235-30 ( EudraCT Number )
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents