COVID-19 trials registries data warehouse

https://lbctr.moph.gov.lb/Trials/Details/4651

Kamal Matli

matlikamal@gmail.com

2021-02-08 00:00:00

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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) &gt, 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 &lt, 300. No criteria for Critical Severity.

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&lt,90 for more than 30 minutes not responding to IV fluids with evidence of end organ damage. Patients with severe bradycardia (&lt,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.

2

LAUMCRH

18

99

Lebanon

No restriction on type of patients

0: No restriction on type of patients

66

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

Phase 3

[{"arm_notes": "", "treatment_id": 2236, "treatment_name": "Atorvastatin+folic acid+l-arginine+nebivolol+nicorandil", "treatment_type": "Metabolic agents+vitamins and dietary supplements+cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]