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

General Practitioners Research Institute

Status and phase

Terminated

Phase 4

Conditions

Corona Virus Infection

Covid19

Treatments

Drug: Dexamethasone

Study type

Interventional

Funder types

NETWORK

Other

Identifiers

NCT04746430

GPRI-21001-COV

2021-000235-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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: