To evaluate the (cost)effectiveness and safety of early dexamethasone treatment in preventing hospital admission or death and reducing disease severity in patients who are monitored after a GP consultation for deteriorating COVID-19. Because the…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be time to first hospital admission.
Secondary outcome
Secondary outcomes are time to self-reported recovery, COVID-19 severity and
self-reported disease burden.
Background summary
The COVID-19 coronavirus has caused a worldwide pandemic of respiratory illness
with increased hospital admission and mortality risks. To keep COVID-19
manageable for the healthcare system, early treatment to prevent hospital
admission is urgently needed. Dexamethasone as a dampener of an exaggerated
cytokine response to COVID-19 is a promising agent to prevent disease
worsening, hospital admission, and death. However, evidence about the
effectiveness, safety, and cost-effectiveness of dexamethasone treatment in
primary care has been inconclusive.
Study objective
To evaluate the (cost)effectiveness and safety of early dexamethasone treatment
in preventing hospital admission or death and reducing disease severity in
patients who are monitored after a GP consultation for deteriorating COVID-19.
Because the remote monitoring arm is developed for this study, and no
information needed for a comprehensive sample size calculation is available, a
pilot study will be performed in 50 patients
Study design
The COVID-19 Primary care Platform for Early treatment and Recovery (COPPER)
study, is an open-label, adaptive platform, randomised controlled trial.
Patients will be randomly assigned (1:1) to the treatment condition
(dexamethasone with safety monitoring of saturation and other signs and
symptoms) vs. the control condition (safety monitoring alone) and followed for
28 days intensively, with follow-up questionnaires at 3,6 and 12 months.
Intervention
6 mg dexamethasone prescribed during ten days and as a precaution combined with
electronic monitoring of saturation and other signs and symptoms
Study burden and risks
Only capacitated adult patients are deemed eligible. Risk stratification (i.e.,
selection of patients with moderately severe COVID-19) will prevent
overtreatment with dexamethasone of patients who will spontaneously recover and
undertreatment of critically ill patients who need to be referred to the
hospital. To prevent adverse effects of dexamethasone, co-medication will be
prescribed when appropriate according to clinical guidelines. As a safety
precaution, worsening of COVID-19 will be tracked by monitoring saturation and
other relevant signs and symptoms using a CE certified medical device. SAEs and
SUSARS will be carefully assessed. A DSMB will be put in place to ensure a
timely discontinuation of the COPPER study if benefits do not outweigh harms.
Professor Enno Dirk Wiersmastraat 5
Groningen 9713GH
NL
Professor Enno Dirk Wiersmastraat 5
Groningen 9713GH
NL
Listed location countries
Age
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 a drop of *4% in SpO2 and/or to
<92% after having performed a 1-minute sit-to-stand test.
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
- Contra-indication for dexamethasone
- History of gastrointestinal bleeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-000235-30-NL |
| CCMO | NL76634.056.21 |