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

NCT04799444 | Unknown

• 1 other identifier: LATE-COVID
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Covid19

Keywords

COVID-19; post-COVID-19; late-COVID-19 complications; SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• Number of participants with severe post-COVID-19 complications

  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

  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 Outcomes (1)

• Post-COVID SCORE

  Baseline

Study Arms (2)

Adult patients with complications post COVID-19

Children with complications post COVID-19

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Polish Mother Memorial Hospital Research Institute: lead

Study Sites (1)

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

Lodz, 93-338, Poland

RECRUITING

Related Publications (5)

• 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.

  PMID: 33621589 BACKGROUND

• 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.

  PMID: 33162899 BACKGROUND

• 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.

  PMID: 32754159 BACKGROUND

• 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.

  PMID: 32570882 BACKGROUND

• 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.

  PMID: 34025853 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The study is planned also to be extended with the genetic predisposition in children to COVID-19 late complications (within independent grant).

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD,FNLA,FAHA,FESC,FASA

Study Record Dates

• First Submitted: March 14, 2021
• First Posted: March 16, 2021
• Study Start: October 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

PL (1)