The COPPER study: Do people with Corona recover faster through early treatment with dexamethasone?

COVID-19 Primary care Platform for Early treatment and Recovery (COPPER) Study: an open-label adaptive platform randomized controlled trial - COPPER

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000235-30-NL

Enrollment

Registered

2021-01-28

Start date

2021-02-09

Completion date

Unknown

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: DEXAMETHASONE CAS Number: 50-02-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in the COPPER study, a patient has to meet all of the following criteria: - Age =18 years - A positive test for SARS-CoV-2 - A GP consultation for deteriorating COVID-19 symptoms Additional inclusion criterion in order to be eligible for randomisation to the trial: - Exercise-induced desaturation, defined as a drop of =4% in SpO2 or to =65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

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 - Conta-indication for dexamethasone

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the effectiveness of early treatment with dexamethasone in preventing hospital admission/death in patients who are carefully monitored by their GP after a consultation for deteriorating COVID-19 ;Secondary Objective: To assess the effectiveness of early treatment with dexamethasone in reducing time to recovery in patients who are carefully monitored by their GP after a consultation for deteriorating COVID-19 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 ;Primary end point(s): The primary outcome will be time to first hospital admission.;Timepoint(s) of evaluation of this end point: during the 28 days of follow-up	—

Measure

Time frame

Main Objective: To assess the effectiveness of early treatment with dexamethasone in preventing hospital admission/death in patients who are carefully monitored by their GP after a consultation for deteriorating COVID-19 ;Secondary Objective: To assess the effectiveness of early treatment with dexamethasone in reducing time to recovery in patients who are carefully monitored by their GP after a consultation for deteriorating COVID-19 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 ;Primary end point(s): The primary outcome will be time to first hospital admission.;Timepoint(s) of evaluation of this end point: during the 28 days of follow-up

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes are time to self-reported recovery, COVID-19 severity and self-reported disease burden.;Timepoint(s) of evaluation of this end point: During the 28 days of follow up and after 3, 6 and 12 months	—

Countries

Netherlands

Contacts

Public ContactMarten Harbers

GPRI

marten@GPRI.nl+31502113898

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026