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

NCT04746430 | Terminated Phase 4 DMC

• 2 other identifiers: GPRI-21001-COV2021-000235-30
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19; Corona Virus Infection

Outcome Measures

Primary Outcomes (1)

• Hospitalization/death

  Time to first hospital admission or death

  28 days

Secondary Outcomes (3)

• Recovery

  28 days

• Disease severity

  28 days

• HCRU

  28 days

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Dexamethasone

Control

NO INTERVENTION

Only remote monitoring

Interventions

Dexamethasone DRUG

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Practitioners Research Institute: lead
• Huisartsenzorg Drenthe: collaborator

Study Sites (1)

GPRI

Groningen, Netherlands

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Janwillem Kocks, Prof

  General Practitioners Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 9, 2021
• Study Start: February 16, 2021
• Primary Completion: April 23, 2021
• Study Completion: April 23, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Locations

NL (1)