Managing Endothelial Dysfunction in COVID-19: A Randomized Clinical Trial at the Lebanese American University Medical Center- Rizk Hospital

Phase 3

Not yet recruiting

• Conditions: COVID-19 and the cardiovascular systemWe will aim at treating endothelial dysfunction caused by covid -19 virus by an endothelial protocol to try to improve the patient's outcome; COVID-19; T51.2

• Registration Number: LBCTR2021014651
• Lead Sponsor: AUMCRH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-02-01
• Study Start: 2021-02-08
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

INCLUSION CRITERIA: Firstly, participants must be in-patient adults 18
years of age and above. Secondly, having PCR-confirmed COVID-19
classified as mild, moderate or severe disease as per the FDA and
admitted to the hospital for inpatient treatment as per the standard
of care, 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
include respiratory rate = 20 breaths per minute, saturation of oxygen
(SpO2) > 93% on room air at sea level, heart rate = 90 beats per
minute without 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 include
respiratory rate = 30 per minute, heart rate = 125 per minute, SpO2 =
93% on room air at sea level or PaO2/FiO2 < 300. No criteria for
Critical Severity.

Exclusion Criteria

EXCLUSION CRITERIA:
Patients unable to tolerate oral
medications. Patients who are already on beta-blockers,
statins or Nicorandil, PDE5 inhibitors, Riociguat.. In addition to
those with shock as defined by SBP<90 for more than 30
minutes not responding to IV fluids with evidence of end organ
damage. Patients with severe bradycardia (<50 bpm) and heart
block greater than first-degree (except in patients with a
functioning artificial pacemaker) should be definitely excluded,
along with those who suffer from decompensated heart failure
and sick sinus syndrome (unless a permanent pacemaker is in
place). Severe hepatic impairment (Child-Pugh class C) or
active liver disease are absolute reasons not to be included
especially those with unexplained persistent elevations of
serum transaminases. Pregnancy or breastfeeding and
hypersensitivity to any of the medications are to be excluded
as well. Myocarditis. Acute pulmonary edema. Hypovolemia.
Patients enrolled in a different randomized study and/or
COVID interventional study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified