Analysis of Health Status of Сomorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection

Completed

• Conditions: Atrial Fibrillation; DVT; CKD; Risk Factor, Cardiovascular; Death; Diabetes; COPD; Covid19; Comorbidities and Coexisting Conditions

• Registration Number: NCT04709120
• Lead Sponsor: Eurasian Association of Therapists

Brief Summary

Comparison of COVID-19 disease course in hospitalized patients infected by SARS-CoV-2 in first and second waves of the novel coronavirus infection

Detailed Description

Non-commercial depersonalized multi-centered registry study on analysis of chronic non-infectious diseases dynamics after SARS-CoV-2 in first and second waves of the novel coronavirus infection in cohort of Russian adult patients.

Retrospective analysis of medical histories and outcomes in adults with pre-existing conditions after SARS-CoV-2 infection. Comorbidities worsening risk factors measuring through evaluation of range of indicators such as dynamics of diabetes, CKD, COPD, bronchial astma, incidence of hypertonic crises, vascular events and others.

Study Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Primary Completion: 2021-03-30
• Study Completion: 2021-05-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2968

Inclusion Criteria

Suspected or confirmed COVID-19 (according to results of swab-test, antibody test, computed tomography or radiography image)

Exclusion Criteria

1. Unwillingness to participate in the study;
2. Age under 18.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
death	4 weeks	death for any reason

Secondary Outcome Measures

Name	Time	Method
Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions	4 weeks	Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions
Number of cases of Acute Kidney Injury depending on Coexisting Conditions	4 weeks	Number of cases of Acute Kidney Injury depending on Coexisting Conditions
Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions	4 weeks	Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions
Number of cases of Cytokine Storm depending on Coexisting Conditions	4 weeks	Number of cases of Cytokine Storm depending on Coexisting Conditions
Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions	4 weeks	Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions
Rate of cases of health status worsening occured during hospitalisation	4 weeks	Rate of cases of health status worsening occured during hospitalisation

Trial Locations

Locations (1)

Eurasian Association of Therapists; 🇷🇺 Moscow, Russian Federation