COVID-19 and the cardiovascular system We 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
Conditions
Interventions
Randomized controlled tiral with 2 arms one intervention arm and the other is a placebo arm
Endothelial dysfunction will be targeted by our medications to improve patient outcome in COVID-19 infection
3g po TID
5 mg po OD
40 mg po OD
10 mg po BID
2.5-5 mg po OD
Endothelial dysfunction and COVID-19
Supplement
medication
Medication
Sponsors
LAUMCRH
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: Clinical improvement was defined as improvement of at least two points from the baseline from date of intervention administration until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1-month status on the six-category ordinal scale. This scale contains the subsequent categories: (1) death (2) hospital admission requiring invasive mechanical ventilation (3) hospital admission, requiring non-invasive positive pressure ventilation (4) hospital admission, requiring oxygen (5) hospital admission, not requiring oxygen (6) discharge.;Timepoints: we will follow our patients for a total of 28 days . ;Measure: Clinical Improvement | — |
Secondary
| Measure | Time frame |
|---|---|
| Name: II. Secondary outcomes: Time Frame: from date of intervention administration until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 1 month: Objective measures of sustained improvement (e.g., return to room air or baseline oxygen requirement) on day 7, 14 and 28 3- Need for invasive mechanical ventilation 4- Length of ICU stay 5- Length of hospital Stay 6- Length of need of mechanical ventilation 7- All cause mortality 8- Occurrence of side effects;Timepoints: we will follow the patients for a total of 28 days;Measure: Clinical Endpoint | — |
Countries
Lebanon
Contacts
Public ContactKamal Matli
LAUMCRH
Outcome results
None listed