Managing Endothelial Dysfunction in Critically Ill COVID-19 Patients at LAUMCRH

NCT04813471 | Unknown Phase 3

• 1 other identifier: LAUMCRH
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 Infection has been found to cause endothelial dysfunction and most of the adverse events stem to this mechanism. So we seek to target endothelial dysfunction in critically Ill patients with covid by giving them an endothelial protocol ( L-arginine, Folic Acid, Statin, Nicorandil, Vitamin B complex) and monitor clinical outcome in those patients.

Conditions

Covid19; Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement

  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

  will followed up for a total of 28 days

Secondary Outcomes (6)

• Need for invasive mechanical ventilation

  F/up for 28 days

• Length of ICU stay

  F/up for 28 days

• Length of hospital Stay

  F/up for 28 days

• Length of need of mechanical ventilation

  F/up for 28 days

• All cause mortality

  F/up for 28 days

Study Arms (2)

Endothelial Dysfunction Protocol

EXPERIMENTAL

Experimental: Endothelial Dysfunction Protocol Our study will evaluate the impact of the endothelial treatment protocol (atorvastatin(or home statin), nicorandil, l-arginine, folic acid and vitamin B complex) in critically Ill patients already on optimal medical therapy for the treatment of COVID-19 virus. Protocol will be given for a total of 14 days or until discharge from the hospital Patients already on home statin will continue their medication or if the are eligible for statins they will recieve 40 mg tablet to be given PO once daily. Nicorandil Nicorandil 10 mg PO BID for the first 7 days and then if no contraindications escalated to 20 mg PO BID for the remaining 7 days Folic Acid Folic Acid 5 mg po once daily L-Arginine L-Arginine 1 g po TID Vitamin B complex (Becozyme) 1 ampoule IV daily

Drug: Endothelial Protocol

Standard of care

NO INTERVENTION

Standard of Care

Interventions

Endothelial Protocol DRUG

Endothelial Protocol

Also known as: nicorandil, Atorvastatin or home statin, Folic acid, vitamin B complex, L-argining

Endothelial Dysfunction Protocol

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 18 years of age or older
• Participants must have a PCR confirming COVID 19 status
• Participants must be classified as critical as per the FDA evidence of critical illness, which is defined as respiratory failure requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high- flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
• Eligible for or already taking Statin

You may not qualify if:

• Patients who are already on statins or Nicorandil.
• Patients labeled as having mild, moderate or severe COVID-19 infection as per the FDA definitions.
• Patients with shock as defined by SBP\<90 for more than 30 minutes not responding to IV fluids with evidence of end organ damage.
• 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
• Hypersensitivity to any of the above-mentioned medications
• On Levodopa.
• Patients on PDE5 inhibitors, Riociguat
• Acute pulmonary edema
• Hypovolemia
• Leber's disease

Sponsors & Collaborators

• Lebanese American University Medical Center: lead

Study Sites (1)

LAUMCRH

Beirut, 000000, Lebanon

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Nicorandil; Atorvastatin; Folic Acid; Vitamin B Complex

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Nitrates; Organic Chemicals; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Kamal Matli, MD

CONTACT

+9613439675; matlikamal@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiology Fellow

Model Details: Open label Randomized Controlled Trial

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: January 20, 2021
• Primary Completion: March 20, 2021
• Study Completion: April 30, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)