Drug Safety and the Occurrence of Complications During Hospitalization in Patients With COVID-19
COR-CARDIO
Prospective Monitoring of Drug Safety and the Occurrence of Complications During Hospitalization in Patients With Cardiovascular Diseases With COVID-19
1 other identifier
observational
1,000
1 country
1
Brief Summary
Hospitalized patients with COVID-19 will be included in the study in centers around Poland. After the hospitalization, a short questionnaire will be completed, including pre-hospitalization diagnoses, pre-hospitalization medications, clinical status on admission, the course, complication and the duration of hospitalization. The questionnaire will be available in paper form and on-line.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2020
CompletedFirst Posted
Study publicly available on registry
May 5, 2020
CompletedStudy Start
First participant enrolled
May 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2021
CompletedMay 6, 2020
May 1, 2020
2 months
April 22, 2020
May 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events
Death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke
through study completion, an average of 2 weeks
Secondary Outcomes (3)
Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke
through study completion, an average of 2 weeks
Ventilation during hospitalization
through study completion, an average of 2 weeks
Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke
prolonged follow up, through study completion, an average of one year
Study Arms (3)
Hospitalized patients with COVID-19
Hospitalized patients with COVID-19 will be included in the study in centers around Poland.
Infected SARS-CoV-2 patients
patients with SARS-CoV-2 infection not requiring hospitalization
Controls
structure-matched and co-existing disease matched control group from the general population.
Interventions
Clinical characteristics from medical records
Eligibility Criteria
Hospitalized patients with COVID-19 will be included in the study in centers around Poland.
You may qualify if:
- Hospitalized patients with COVID-19
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Cardiology
Warsaw, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrzej Januszewicz, MD, PhD
National Institute of Cardiology
- PRINCIPAL INVESTIGATOR
Tomasz Hryniewiecki, MD, PhD
National Institute of Cardiology
- PRINCIPAL INVESTIGATOR
Rafal Dabrowski, MD, PhD
National Institute of Cardiology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2020
First Posted
May 5, 2020
Study Start
May 5, 2020
Primary Completion
June 24, 2020
Study Completion
August 24, 2021
Last Updated
May 6, 2020
Record last verified: 2020-05