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

Phase 1

• Conditions: COVID-19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000235-30-NL
• Lead Sponsor: General Practitioners Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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 <92% after having performed a 1-minute sit-to-stand test.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified