Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System

NCT04353245 | Unknown

• 1 other identifier: UAP107
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) poses a significant threat to global health. As the disease progresses, a series of acute complications tend to develop in multiple organs. Beyond the supportive care, no specific treatment has been established for COVID-19. The effectiveness, both short-term and long-term, of some promising antivirals, such as the hydroxychloroquine combination with azithromycin, needs to be evaluated. This study aims to investigate the predictive role of cardiac biomarkers and pulmonary symptoms for late complications of COVID-19 coronavirus infection on the heart and lung in patients treated with the hydroxychloroquine / azithromycin combination therapy. Thus, COVID-19 coronavirus patients undergoing hydroxychloroquine / azithromycin combination therapy will be compared to patients not undergoing this therapy. The comparison will be made by the analysis of the relationships between (1) levels of ultrasensitive cardiac troponins collected at the beginning of the infection and cardiac magnetic resonance data in the 3rd and 12th months of troponin collection and (2) findings CT scans and the results of the ergospirometers tests performed in those same periods. It is expected to demonstrate that: (1) cardiac troponin and lung tomographic findings can predict late complications of COVID-19 coronavirus infection in the heart and lung, assessed by cardiac magnetic resonance and ergospirometers one year after the beginning of the infection, and (2) hydroxychloroquine / azithromycin combined therapy can abolish the onset of these complications late. Furthermore, the results may point to the need for more rigorous monitoring of cardiologists and pulmonologists of these patients, due to the risk of hemodynamic complications, arrhythmogenic and respiratory.

Conditions

COVID19; Corona Virus Infection; Myocardial Injury; Pneumonia

Keywords

covid19; corona virus infection; myocardial injury; hydroxychloroquine; azithromycin

Outcome Measures

Primary Outcomes (2)

• Fibrosis

  presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry

  12 months

• Ergospirometers

  Decreased functional capacity on ergospirometers

  12 monthes

Study Arms (2)

Arm treatment (HCQ + Azithro)

Participants that used HCQ + Azithro in their treatment for COVID19

Other: BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM

Arm control (without HCQ + Azithro)

Participants that did not used HCQ + Azithro in their treatment for COVID19

Other: BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM

Interventions

BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM OTHER

Organize care follow-up for patients who have had COVID-19 coronavirus infection for scientific purposes. Thus, it is expected to obtain relevant data on cardiac sequelae and pulmonary. These data are important for understanding the long-term prognosis of patients surviving this infection.

Arm control (without HCQ + Azithro); Arm treatment (HCQ + Azithro)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

positive test for covid19

You may qualify if:

• positive test for covid19
• high ultrasensitive troponin
• pulmonary damage \> 25%
• no cardiac or lung known disease
• Consent inform signed

You may not qualify if:

• intensive care and mechanical ventilation needs
• chronic inflammatory disease
• active neoplasm
• use of immunosuppressant
• renal failure
• pregnant woman

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração - Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Pneumonia

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Factors

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; doctoral supervisor

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 20, 2020

Record last verified: 2020-04

Locations

BR (1)