NCT04501822

Brief Summary

The primary objective of the study is to assess the cardiac status of COVID-19 pneumonia patients during 1 year after discharge

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

July 28, 2020

Last Update Submit

April 26, 2022

Conditions

Covid19Cardiac Complication

Keywords

Covid19Cardiovascular DiseaseEchocardiography

Outcome Measures

Primary Outcomes (1)

  • Echocardiographic assessment of cardiac function

    Echocardiographic assessment of global strain parameters at 3 and 12 months after discharge

    up to one year

Secondary Outcomes (7)

  • МАССЕ

    up to one year

  • Quantitative analysis of parenchymal lung damage

    up to one year

  • Functional exercises capacity assessment

    up to one year

  • Evaluation of renal function

    up to one year

  • Evaluation of inflammation

    up to one year

  • +2 more secondary outcomes

Study Arms (1)

Covid19 pneumonia patients

The study includes men and women ≥18 years old with documented COVID-19 pneumonia

Diagnostic Test: Evaluation of clinical, instrumental and laboratory diagnostics tests

Interventions

Evaluation of clinical, instrumental and laboratory diagnostics testsDIAGNOSTIC_TEST

During follow-up visits patients undergo clinical, instrumental and laboratory diagnostics tests

Covid19 pneumonia patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study includes men and women ≥18 years old with documented COVID-19 pneumonia

You may qualify if:

  • Patients with documented COVID-19 pneumonia

You may not qualify if:

  • Patients with cancer
  • Impossible to follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science

Tyumen, 625026, Russia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

COVID-19Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Elena Yaroslavskaya, PhD

    Tyumen Cardiology Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 6, 2020

Study Start

July 19, 2020

Primary Completion

July 19, 2021

Study Completion

December 31, 2021

Last Updated

April 27, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)