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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-16

Study Completion Date

2021-04-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19 Corona Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms

Control

Only remote monitoring

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexamethasone

6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years
* A positive test for SARS-CoV-2
* A GP consultation for deteriorating COVID-19 symptoms

\- 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No