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

NCT ID: NCT04799444

Last Updated: 2021-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adult patients with complications post COVID-19

No interventions assigned to this group

Children with complications post COVID-19

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Polish Mother Memorial Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Maciej Banach

MD,PhD,FNLA,FAHA,FESC,FASA

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland

Lodz, , Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA

Role: primary

+48 42 2711124

Joanna Lewek, MD, PhD

Role: backup

+48 422721593

References

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Parsamanesh N, Karami-Zarandi M, Banach M, Penson PE, Sahebkar A. Effects of statins on myocarditis: A review of underlying molecular mechanisms. Prog Cardiovasc Dis. 2021 Jul-Aug;67:53-64. doi: 10.1016/j.pcad.2021.02.008. Epub 2021 Feb 20.

Reference Type BACKGROUND
PMID: 33621589 (View on PubMed)

Petrovic V, Radenkovic D, Radenkovic G, Djordjevic V, Banach M. Pathophysiology of Cardiovascular Complications in COVID-19. Front Physiol. 2020 Oct 9;11:575600. doi: 10.3389/fphys.2020.575600. eCollection 2020.

Reference Type BACKGROUND
PMID: 33162899 (View on PubMed)

Bhaskar S, Sinha A, Banach M, Mittoo S, Weissert R, Kass JS, Rajagopal S, Pai AR, Kutty S. Cytokine Storm in COVID-19-Immunopathological Mechanisms, Clinical Considerations, and Therapeutic Approaches: The REPROGRAM Consortium Position Paper. Front Immunol. 2020 Jul 10;11:1648. doi: 10.3389/fimmu.2020.01648. eCollection 2020.

Reference Type BACKGROUND
PMID: 32754159 (View on PubMed)

Radenkovic D, Chawla S, Pirro M, Sahebkar A, Banach M. Cholesterol in Relation to COVID-19: Should We Care about It? J Clin Med. 2020 Jun 18;9(6):1909. doi: 10.3390/jcm9061909.

Reference Type BACKGROUND
PMID: 32570882 (View on PubMed)

Lewek J, Jatczak-Pawlik I, Maciejewski M, Jankowski P, Banach M. COVID-19 and cardiovascular complications - preliminary results of the LATE-COVID study. Arch Med Sci. 2021 Mar 18;17(3):818-822. doi: 10.5114/aoms/134211. eCollection 2021.

Reference Type RESULT
PMID: 34025853 (View on PubMed)

Other Identifiers

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LATE-COVID

Identifier Type: -

Identifier Source: org_study_id

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