Managing Endothelial Dysfunction in COVID-19 : A Randomized Controlled Trial at LAUMC
Status:
Recruiting
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
COVID-19 infection was shown to cause endothelial dysfunction .
At the level of the endothelium the pathophysiological mechanisms have been hypothesized and
were divided into pro-coagulant, pro-inflammatory, anti-fibrinolytics, impaired barrier
function, vasoconstrictor and pro-oxidant. So far, the pro-coagulant and pro-inflammatory
pathways have been studied and as a result dexamethasone and anticoagulation became part of
the standard therapies for the disease. However, so far, no RCT has been evaluated on
targeting the vasoconstrictive and antioxidant pathways with an aim of revealing clinical
benefit.
So, with this trial we intend to provide a regiment composed of several medications we
hypothesize will act on several downstream pathways that would improve endothelial function
primarily via the increase in NO production and release.
At the time of this proposal there has been no randomized trials evaluating or testing the
use of cardiovascular drugs targeting endothelial dysfunction in COVID-19 patients. As
previously noted there has been a call to study these drugs and their effect after a strong
research regarding their theorized effectiveness. For evidence, there was a recently
published meta-analysis evaluating the role of statins in COVID-19 with preliminary findings
suggested a reduction in fatal or severe disease by 30% and discredited the suggestion of
harm, that emphasized on the need of well-designed randomized controlled trial to confirm the
role of statins in COVID-19 patients.
Our study would help determine the potential therapeutic effect of the endothelial protocol
as adjunct to mainstream management. This study seeks to further our knowledge in treating
COVID-19 to ultimately improve clinical outcomes and reduce complications.
Phase:
Phase 3
Details
Lead Sponsor:
Lebanese American University Medical Center
Treatments:
Atorvastatin Folic Acid Nebivolol Nicorandil Vitamin B Complex