Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection (ACTIV4)

May 6, 2023 updated by: Tamara Kriukova, Eurasian Association of Therapists

Analysis of Health Status of Сomorbid Adult Patients With COVID-19 Hospitalised in Fourth Wave of SARS-CoV-2 Infection (ACTIV4)

Depersonalized multi-centered registry initiated to analyze dynamics of non-infectious diseases after SARS-CoV-2 infection in population of Eurasian adult patients.

Study Overview

Status

Completed

Conditions

Detailed Description

Assessment of hospital course and health status during 3, 6, 12 months after discharge in COVID-19 patients in cohorts with comorbidities and without comorbidities. Evaluation of comorbidity impact to severity of novel coronavirus disease and comorbidity impact to demand for medical care.

Study Type

Observational

Enrollment (Actual)

3554

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

No

Sampling Method

Probability Sample

Study Population

Anonymized male and female patients over 18 years hospitalized with COVID-19 during the fourth wave of novel coronavirus disease.

Description

Inclusion Criteria:

  • Suspected or confirmed COVID-19

Exclusion Criteria:

  • Age under 18 years.
  • Refusal to be involved in study;

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death for any cause
Time Frame: From date of hospitalization until the date of first documented date of death from any cause, assessed up to 12 months
rate of lethal outcomes
From date of hospitalization until the date of first documented date of death from any cause, assessed up to 12 months
hospitalization for any cause
Time Frame: 12 months after discharge
rate of hospitalization for any cause
12 months after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
onset of any disease diagnosed 1 year after discharge
Time Frame: 1 year after discharge
rate of patients with onset of any disease diagnosed 1 year after discharge
1 year after discharge
rate of demand for medical care
Time Frame: 1 year after discharge
number of patients seeking for health care after discharge
1 year after discharge

Collaborators and Investigators

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

Sponsor

Eurasian Association of Therapists

Investigators

  • Principal Investigator: Alexander Arutyunov, MD, PhD, Eurasian Association of Therapists

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)

February 21, 2022

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

April 21, 2023

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 7, 2022

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 6, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTIV4

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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