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

Covid19 Clinical Trial

— COPPER  

Official title:

COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study: an Open-label Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04746430
• Other study ID #: GPRI-21001-COV
• Secondary ID: 2021-000235-30
• Status: Terminated
• Phase: Phase 4
• Start date: February 16, 2021
• Est. completion date: April 23, 2021

Study information

• Verified date: May 2021
• Source: General Practitioners Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 23, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• Covid19

Intervention

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

Locations

Country	Name	City	State
Netherlands	GPRI	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
General Practitioners Research Institute	Huisartsenzorg Drenthe

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization/death	Time to first hospital admission or death	28 days
Secondary	Recovery	To assess the effectiveness of early treatment with dexamethasone in reducing time to recovery inpatients who are carefully monitored by their GP after a consultation for deteriorating COVID-19	28 days
Secondary	Disease severity	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	28 days
Secondary	HCRU	To assess the effectiveness of the intervention in reducing healthcare resource utilization (HCRU)	28 days