Cardiovascular Manifestations of COVID-19 Research Study Participants
Company: Memorial Hermann Health System
Location: Houston , TX
Category: Clinical Research Studies, General
Job Type: Full Time
Posted: 9/22/2020

Brief Summary:
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen responsible for the novel coronavirus disease 2019 (COVID-19). The first reports of COVID-19 came from Wuhan, China in December of 2019.

Since then, the disease has spread rapidly around the globe, accounting for thousands of deaths in multiple countries. On March 11th, 2020, the World Health Organization declared COVID-19 as a pandemic.

Although COVID-19 manifests primarily as a respiratory illness, several cardiovascular implications have been reported related to its natural course and treatment.

Its exact effect on the cardiovascular system though is currently unknown.

Therefore, we propose a retrospective, observational, case-control study looking for cardiovascular manifestations of COVID-19, including laboratory evidence of myocardial injury, electrocardiographic changes, arrhythmias and echocardiographic abnormalities.

Hospitalized patients admitted with fever, cough, sore throat, and/or dyspnea who were tested positive for SARS-CoV-2 will be included in our study and will be matched based on their age and gender with patients admitted with similar symptoms who tested negative for SARS-CoV-2.

The electronic medical charts of the study subjects will be reviewed and relevant demographic, clinical, laboratory and imaging findings will be deidentified and recorded.

Since our study will be a retrospective chart review study it carries minimal risk for the patients and the investigators.

Cardiovascular disease associated with COVID-19 might be contributing to the high mortality rates and its recognition will allow for prevention, early diagnosis and appropriate treatment.

This will be the first, large, case-control study assessing cardiovascular involvement of COVID-19 in a well-defined cohort of patients.



Study Type: Observational

Estimated Enrollment: 500 participants

Observational Model: Case-Control

Time Perspective: Retrospective

Official Title: Cardiovascular Manifestations of Hospitalized Patients With Coronavirus Disease 2019

Actual Study Start Date: March 30, 2020

Estimated Primary Completion Date: March 2021

Estimated Study Completion Date: March 2022


Inclusion Criteria

  • Signed informed consent.
  • Positive test for COVID-19 up to 7 days before participation in study.
  • Able to begin study treatment no later than 10 days from self-reported onset of COVID-19 related symptom(s):
    • fever or feeling feverish
    • cough
    • shortness of breath or difficulty breathing at rest or when active
    • sore throat      
    • body pain or muscle pain/aches
    • fatigue      
    • headache      
    • chills      
    • blocked nose/nasal congestion
    • runny nose      
    • loss of taste or smell   
    • nausea or vomiting      
  • diarrhea   
  • temperature ≥ 38°C (100.4°F)
  • One or more of the following signs/symptoms within 48 hours of participating in the study:
    •    fever or feeling feverish
    •    cough
    •    shortness of breath or difficulty breathing at rest or when active
    • sore thr   oat
    • body pain or m   uscle pain/aches
    • fatigue   
    • headache   
    • chills   
    • blocked nose   /nasal congestion
    • runny nose   
    • loss of taste or sm   ell
    • nausea or vomiting   
    • diarrhea   
    • temperature ≥ 3   8°C (100.4°F)
    • Oxygen levels of ≥92%    when resting (measured by study staff within 48 hours of participating in the study), unless participant is receiving long-term supplementary oxygen for an underlying lung condition.
  • Participant must agree not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first.


Exclusion Criteria

  • History of or current hospitalization for COVID-19.
  • Current need for hospitalization or immediate medical attention.
  • Any use of the following medications up to 30 days before participating in the study:
  • Hydroxychloroquine (except for long-term autoimmune diseases)
  • Chloroquine and/or ivermectin (unless used for parasitic infection)
  • Remdesivir, systemic and inhaled steroids (unless used for long-term conditions)
  • HIV protease inhibitors (unless used long-term for HIV infection)
  • Receipt of plasma from a person who recovered from COVID-19 any time before participating in the study.
  • Receipt of a SARS-CoV-2 vaccine any time before participating in the study.
  • Receipt of other investigational treatments for SARS-CoV-2 any time before participating in the study (not including drugs approved and taken for other conditions/diseases).
  • Receipt of systemic steroids (e.g. prednisone, dexamethasone) or inhaled steroids up to 30 days before participating in the study, unless this is a stable dose for a long-term condition.
  • Known allergy/sensitivity or hypersensitivity to study drug or placebo.
  • Any condition requiring surgery up to 7 days before participating in the study, or that is considered life threatening up to 30 days before participating in the study.
  • Other investigational drug protocol-defined inclusion/exclusion criteria may apply.

Houston, TX
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