Clinical trial: Managing Endothelial Dysfunction in COVID-19 : A Randomized Controlled Trial at LAUMC (NCT04631536)

Eligibility criteria:
Inclusion Criteria:

          -  Adults 18 years of age and above admitted for inpatient treatment of COVID-19
             infection

          -  PCR-confirmed COVID-19 classified as mild, moderate or with severe disease as per the
             FDA.

        With mild being a positive testing by standard RT-PCR assay or equivalent test and symptoms
        of mild illness with COVID-19 that could include fever, cough, sore throat, malaise,
        headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea.
        No clinical signs indicative of Moderate, Severe, or Critical Severity.

          -  Moderate defined as positive testing by standard RT-PCR assay or equivalent testing
             and symptoms of moderate illness which could include any symptom of mild illness or
             shortness of breath with exertion. Clinical signs suggestive of moderate illness with
             COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen
             (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute. No clinical
             signs indicative of Severe or Critical Illness Severity.

          -  Severe symptoms could include any symptom of moderate illness or shortness of breath
             at rest, or respiratory distress. Clinical signs indicative of severe systemic illness
             with COVID-19, such as respiratory 468 rate ≥ 30 per minute, heart rate ≥ 125 per
             minute, SpO2 ≤ 93% on room air at sea level or 469 PaO2/FiO2 < 300.

          -  No criteria for Critical Severity.

          -  Eligible for or taking statin

        Exclusion Criteria:

          -  Participant in another RCT

          -  Myocarditis

          -  Patients who are already on beta-blockers

        Patients already on Nicorandil.

        . Patients taking PDE5 inhibitors or Riociguat

        .Shock as defined by SBP<90 for more than 30 minutes not responding to IV fluids with
        evidence of end organ damage.

        .Severe bradycardia (<50 bpm).

        .Heart block greater than first-degree (except in patients with a functioning artificial
        pacemaker).

        .Decompensated heart failure.

        .Sick sinus syndrome (unless a permanent pacemaker is in place).

        .Severe hepatic impairment (Child-Pugh class C) or active liver disease.

        .Unexplained persistent elevations of serum transaminases.

        .Pregnancy or breastfeeding.

        .Hypersensitivity to any of the medications.

          -  Can't take medications orally

          -  Patient refuses to participate
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Contradiction