Drug Safety and the Occurrence of Complications During Hospitalization in Patients With COVID-19

• Conditions: Hypertension; Cardiovascular Risk Factor; Cardiovascular Diseases; COVID
• Interventions: Other: Clinical data

• Registration Number: NCT04374110
• Lead Sponsor: National Institute of Cardiology, Warsaw, Poland

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.

Detailed Description

SARS-Cov-2 infection is characterized by a varied clinical course, from asymptomatic to severe respiratory failure in the course of pneumonia, which can be fatal. There are reports in the literature regarding the relationship between the course of an acute respiratory disease syndrome caused by SARS-CoV-2 virus infection (Coronavirus 2019, COVID-19) and the history of cardiovascular diseases (CVD), including hypertension. It is postulated that the shared element of the pathogenesis of CVD, hypertension and COVID-19 is the renin-angiotensin system and one of its elements, the angiotensin converting enzyme 2 (ACE2). It has been postulated by some authors that in the course of hypertension and antihypertensive treatment with renin-angiotensin system inhibitors, there may be an upregulation of ACE2, which in turn may be related to a higher risk of more severe course of COVID-19. On the other hand there is also data the renin-angiotensin system inhibitors by increasing ACE2 concentration may be protective in the course of severe pneumonia.

The study undertaken by the National Institute of Cardiology aims to assess the safety of the cardiovascular drugs in relation to the occurrence of complications during hospitalization in patients with CVD and COVID-19 infection. The study is being conducted by Polish-German collaboration and was initiated by prof Reinhold Kreutz from Institute of Clinical Pharmacology and Toxicology, Charite, Berlin, Germany and team from National Institute of Cardiology lead by prof. Andrzej Januszewicz and prof. Tomasz Hryniewiecki, Director of the National Institute of Cardiology.

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.

It will also be planned to include control groups from the official databases: 1) patients with SARS-CoV-2 infection not requiring hospitalization, and 2) structure-matched and co-existing disease matched control group from the general population.

Study Timeline

• Study First Submitted: 2020-04-22
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-02
• Study Start: 2020-05-05
• Study First Posted: 2020-05-05
• Last Update Submitted: 2020-05-05
• Last Update Posted: 2020-05-06
• Primary Completion: 2020-06-24
• Study Completion: 2021-08-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Hospitalized patients with COVID-19

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infected SARS-CoV-2 patients	Clinical data	patients with SARS-CoV-2 infection not requiring hospitalization
Hospitalized patients with COVID-19	Clinical data	Hospitalized patients with COVID-19 will be included in the study in centers around Poland.
Controls	Clinical data	structure-matched and co-existing disease matched control group from the general population.

Primary Outcome Measures

Name	Time	Method
Adverse events	through study completion, an average of 2 weeks	Death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke

Secondary Outcome Measures

Name	Time	Method
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	Number of participants with death, myocardial infarction, heart failure, myocarditis, acute renal failure, stroke analyzed separately for each of the endpoints
Ventilation during hospitalization	through study completion, an average of 2 weeks	Ventilation during hospitalization

Trial Locations

Locations (1)

National Institute of Cardiology; 🇵🇱 Warsaw, Poland