Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System (PostCOVID19)

Study of Biomarkers in the Long-term Impact of Coronavirus Infection in the Cardiorespiratory System: Effect of Hydroxychloroquine / Azithromycin Combined Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Pneumonia; Myocardial Injury; Corona Virus Infection; COVID19
• Intervention / Treatment: Other: BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM

Detailed Description

The aim of this study is to investigate the predictive role of cardiac biomarkers and significant pulmonary complications for late infection complications COVID-19 coronavirus on the heart and lung in patients treated with hydroxychloroquine / combination therapy azithromycin.

COVID-19 positive test patients will be divided into two groups according to therapeutic conduct. So, with a case-control distribution respecting age and sex, the two patient groups will be defined as "arm" with therapy (study population) and "Arm" without therapy (population control). This study is prospective and consists of three times:

1) T0- Moment of inclusion of the patient in the study, which coincides with the collection of clinical data and laboratory tests.

(2) T3- In the 3rd month after inclusion in the study, the patient will make a medical visit where data new laboratory tests will be acquired.

(3) T12- In the 12th month after inclusion in the study, the patient will make another medical visit where data clinical data will be obtained. Laboratory tests, which were altered during visit T3 will be repeated.

COVID-19 coronavirus patients undergoing therapy combined hydroxychloroquine / azithromycin will be compared to patients not undergoing this therapy. The comparison will be performed by analyzing the relationships between (1) troponin levels ultrasensitive cardiac data collected at the beginning of the infection and data of cardiac magnetic resonances in the 3rd and 12th month of collection troponins and (2) acute tomographic findings and the results the ergospirometers tests performed in those same periods.

In our understanding of COVID-19, its diagnosis, prevention and treatment are evolving quickly. As the disease spreads and new evidence emerges, it would be prudent to identify risk factors for the development of late cardiorespiratory complications in patients survivors of serious COVID-19 infections.

This prospective study of patients with COVID-19, involving a systematic record of clinical-laboratory variables and chronic cardiorespiratory complications, will be beneficial for the development of a risk model for these complications and to identify and / or predict the response to various treatment modalities.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • Instituto do Coração - Hospital das Clínicas - Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

positive test for covid19

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibrosis	presence of fibrosis on cardiac resonance and / or decreased functional capacity on ergospirometry	12 months
Ergospirometers	Decreased functional capacity on ergospirometers	12 monthes

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): September 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 15, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: myocardial injury; covid19; hydroxychloroquine; azithromycin; corona virus infection
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Coronavirus Infections; Infections; Communicable Diseases; Virus Diseases
• Other Study ID Numbers: UAP107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No