LATE-COVID/LATE-COVID-Kids - Observational Study in Children and Adults (LATE-COVID)

March 14, 2021 updated by: Maciej Banach, Polish Mother Memorial Hospital Research Institute

Complications Post COVID-19 - Observational Study in Children and Adults

All consecutive patients admitted to the Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland between 1st October 2020 and 31st December 2021 due to symptoms, which might reflect complications following COVID-19, will be included in the observational cohort study. Data concerning clinical characteristics, results of laboratory tests, other studies, such as: echocardiography, 24 hours ambulatory ECG recording will be collected. The study is planned also to be extended with the genetic predisposition in children to COVID-19 late complications (within independent grant).

Study Overview

Status

Unknown

Conditions

Detailed Description

A wide range of complications have been linked to COVID-19 - the coronavirus disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is well known that COVID-19 affects multiple organs. Most of the data however present the early complications during the acute phase of the infection, and there is still a lack of knowledge on the late complications that might appear after recovery. Additionally, the long-term complications in patients who were asymptomatic or had mild symptoms during the acute phase of infection, not requiring hospitalization, oxygen therapy or mechanical ventilation has not been fully studied. Therefore, our aim was to assess factors related to the severity of post-COVID complications among patients without severe symptoms in the acute phase of COVID-19. The study will include consecutive COVID-19 convalescents (the infection of coronavirus was confirmed with real-time polymerase chain reaction test or positive result of autoantibodies) admitted to the Departments of Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland, for complications. Both children and adults will be included in the study. The patients will have laboratory testing and other studies due to the character of symptoms.

Study Type

Observational

Enrollment (Anticipated)

500

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

  • Poland
      • Lodz, Poland, 93-338
        • Recruiting
        • Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA
        • Sub-Investigator:
          • Joanna Lewek, MD, PhD
        • Sub-Investigator:
          • Izabela Jatczak-Pawlik, PhD

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All consecutive COVID-19 convalescents admitted to the Departments of Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland, for complications

Description

Inclusion Criteria:

  • consecutive COVID-19 convalescents (the infection of coronavirus was confirmed with real-time polymerase chain reaction test or positive result of autoantibodies) admitted to the Departments of Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland, for complications

Exclusion Criteria:

  • no history of COVID-19 infection,
  • lack of complications post COVID-19,
  • severe course of Sars-COV-2 infection,
  • lack pf patient's agreement to be included in the 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

Cohorts and Interventions

Group / Cohort
Adult patients with complications post COVID-19
Children with complications post COVID-19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with severe post-COVID-19 complications
Time Frame: Baseline
Data concerning clinical characteristics, results of laboratory tests, other studies, such as: echocardiography, 24 hours ambulatory ECG recording will be collected. According to the results patients will be qualified to severe or mild complication group
Baseline
Factors related to the severity of post-COVID-19 complications
Time Frame: Baseline
Data concerning clinical characteristics, results of laboratory tests, other studies, such as: echocardiography, 24 hours ambulatory ECG recording will be collected to verify which of them can be related to the severity of post-COVID-19 complications.
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-COVID SCORE
Time Frame: Baseline
We aim to create a post-COVID SCORE that helps to predict the risk of late complications both in children and adults.
Baseline

Collaborators and Investigators

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

Sponsor

Polish Mother Memorial Hospital Research Institute

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.

General Publications

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 (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

March 14, 2021

First Submitted That Met QC Criteria

March 14, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 14, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LATE-COVID

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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