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

September 6, 2023 updated by: Tamara Kriukova, Eurasian Association of Therapists
Comparison of COVID-19 disease course in hospitalized patients infected by SARS-CoV-2 in first and second waves of the novel coronavirus infection

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2968

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 101000
        • Eurasian Association of Therapists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Anonymized male and female patients over the age of 18 hospitalised since October, 1st, 2020

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death
Time Frame: 4 weeks
death for any reason
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cases of Acute Kidney Injury depending on Coexisting Conditions
Time Frame: 4 weeks
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 4 weeks
Rate of cases of health status worsening occured during hospitalisation
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

January 13, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 14, 2021

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTIV-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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