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

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

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.

Study Overview

• Status: Terminated
• Conditions: Covid19; Corona Virus Infection
• Intervention / Treatment: Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • GPRI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: General Practitioners Research Institute
• Collaborators: Huisartsenzorg Drenthe
• Investigators: Principal Investigator: Janwillem Kocks, Prof, General Practitioners Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Actual): April 23, 2021
• Study Completion (Actual): April 23, 2021

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: GPRI-21001-COV; 2021-000235-30 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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