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

Sponsor

Eurasian Association of Therapists (Other)

Overall Status

Completed

CT.gov ID

NCT04709120

Collaborator

(none)

2,500

Enrollment

Location

11.6

Actual Duration (Months)

215

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Comorbidities and Coexisting Conditions Risk Factor, Cardiovascular Death Diabetes COPD Atrial Fibrillation DVT CKD

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

2500 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jan 11, 2021

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

death [4 weeks]
death for any reason

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

Unwillingness to participate in the study;
Age under 18.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurasian Association of Therapists	Moscow		Russian Federation	101000

Sponsors and Collaborators

Eurasian Association of Therapists

Investigators

Study Director: Grigoriy Arutyunov, MD, PhD, Eurasian Association of Therapists
Study Chair: Ekaterina Tarlovskaya, MD, PhD, Eurasian Association of Therapists
Principal Investigator: Aleksander Arutyunov, MD, PhD, Eurasian Association of Therapists