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

Covid19 Clinical Trial

— LATE-COVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04799444
• Other study ID #: LATE-COVID
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: March 2021
• Source: Polish Mother Memorial Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Locations

Country	Name	City	State
Poland	Polish Mother Memorial Research Institute (PMMHRI) in Lodz, Poland	Lodz

Sponsors (1)

Lead Sponsor	Collaborator
Polish Mother Memorial Hospital Research Institute

Country where clinical trial is conducted

Poland, 

References & Publications (5)

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. — View Citation

Lewek J, Jatczak-Pawlik I, Maciejewski M, Jankowski P, Banach M. COVID-19 and cardiovascular complications -the preliminary results of the LATE- COVID study. Arch Med Sci 2021; 17(5); in press.

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 Feb 20. pii: S0033-0620(21)00022-0. doi: 10.1016/j.pcad.2021.02.008. [Epub ahead of print] Review. — View Citation

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. Review. — View Citation

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). pii: E1909. doi: 10.3390/jcm9061909. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-COVID SCORE	We aim to create a post-COVID SCORE that helps to predict the risk of late complications both in children and adults.	Baseline
Primary	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
Primary	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