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

Diabetes Clinical Trial

— ACTIV-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709120
• Other study ID #: ACTIV-2
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: September 2023
• Source: Eurasian Association of Therapists
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2968
• Est. completion date: May 30, 2021
• Est. primary completion date: March 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• CKD
• Comorbidities and Coexisting Conditions
• COPD
• COVID-19
• Covid19
• Death
• Diabetes
• DVT
• Risk Factor, Cardiovascular

Locations

Country	Name	City	State
Russian Federation	Eurasian Association of Therapists	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Eurasian Association of Therapists

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	death for any reason	4 weeks
Secondary	Number of cases of Acute Kidney Injury depending on Coexisting Conditions	Number of cases of Acute Kidney Injury depending on Coexisting Conditions	4 weeks
Secondary	Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions	Number of cases of Myocarditis and Acute Coronary Events depending on Coexisting Conditions	4 weeks
Secondary	Number of cases of Cytokine Storm depending on Coexisting Conditions	Number of cases of Cytokine Storm depending on Coexisting Conditions	4 weeks
Secondary	Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions	Number of thrombotic and thromboembolic complications of COVID-19 depending on Coexisting Conditions	4 weeks
Secondary	Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions	Decline in GFR excluding Acute Kidney Injury by the time of discharge depending on Coexisting Conditions	4 weeks
Secondary	Rate of cases of health status worsening occured during hospitalisation	Rate of cases of health status worsening occured during hospitalisation	4 weeks

External Links

•   design of observational studies "Analysis of Chronic Non-infectious Diseases Dynamics After COVID-19 Infection in Adult Patients" and "Analysis of Health Status of ?omorbid Adult COVID-19 Patients Hospitalised in Second Wave of SARS-CoV-2 Infection"
•   Impact of Kidney Damage on the Course and Prognosis of COVID-19 Infection According to the International Registry "Analysis of Chronic Non-Infectious Diseases Dynamics After Covid-19 Infection in Adult Patients"
•   Lipid profile in hospitalized patients with COVID-19 depending on the outcome of its acute phase: data from the international registry "Dynamics analysis of comorbidities in SARS-CoV-2 infection survivors"
•   The impact of carbohydrate metabolism disorders on the early and long-term clinical outcomes of patients with COVID-19 according to the AKTIV and AKTIV 2 registries.