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Covid19Phase 3NCT04813471

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

A Phase 3 study testing Endothelial Protocol in people with Covid19 and Endothelial Dysfunction, run by Lebanese American University Medical Center at 1 site in Lebanon.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Covid19, Endothelial Dysfunction
What is being tested?
Endothelial Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteLebanon
Study dates
20 Jan 2021to 30 Apr 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • On Levodopa.
  • Patients on PDE5 inhibitors, Riociguat
  • Acute pulmonary edema
  • Hypovolemia
  • Leber's disease

Trial locations and contacts

1 site in 1 country.

Kamal Matli, MD contact

+9613439675

matlikamal@gmail.com

Lebanon1 site, 1 recruiting
  • LAUMCRH

    Beirut, 000000

    Georges Ghanem, MD, 9611200800, georges.ghanem@laumcrh.com

    Recruiting

Other trials in Lebanon

About this study

Official title: Managing Endothelial Dysfunction in Critically Ill COVID-19 Patients at the Lebanese American University Medical Center- Rizk Hospital

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.

Read the detailed description

Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) is the novel pathogen responsible for coronavirus disease 2019 (COVID-19) first discovered in Wuhan, China [1]. Since its emergence in late December 2019, many pathophysiological mechanisms have been proposed with multiple pathways that involve various organ systems [2, 3]. Although considered at its emergence as a respiratory infection with manifestations ranging from lower respiratory tract infection to pneumonia and advancing to acute respiratory disease syndrome (ARDS) in its final stages, recent evidence has highlighted how disseminated the virus can be affecting almost every organ be it the heart, kidneys, or blood vessels . Recent trends in research have focused on elucidating the cardiovascular dysfunction in COVID-19 patients especially following studies showing that cardiovascular risk factors are among the most common presenting comorbidities and that cardiovascular complications of SARS-CoV-2 are among the most lethal [4-11] . Initial research revealed that the virus makes use of the angiotensin-converting enzyme 2 (ACE-2) receptor, a widely expressed receptor found in multiple cells lining the lung, heart, gastrointestinal tract, kidneys and endothelial cells to infiltrate host cells. Another prominent mechanism of infection is immune system dysregulation manifesting as a cytokine storm and inflammatory response over-activation [12, 13].

Attempts at laying out a comprehensive or unifying pathogenesis of a COVID-19 infection have singled out endothelial dysfunction as a core pathway [14]. The endothelium is a monolayer of squamous endothelial cells lining the inner surface of arteries, veins and microvasculature. The endothelium hence plays a major role in homeostasis with interactive roles in blood pressure regulation, anti-coagulation and immune protection. Moreover, it is relevant to note that the most common comorbidities that present with COVID-19 such as hypertension, diabetes, obesity and old age are all underlined by pre-existing endothelial damage or dysfunction. As such, endothelial dysfunction and oxidative stress and their relation to the manifestation and progression of COVID-19 infections has gained significant traction in recent publications [15]. This breakthrough exposes several causes of endothelial dysfunction which include direct lining attack, hypoxia, cytokine storm and suppressed endothelial nitric oxide synthase (eNOS) with concomitant nitric oxide deficiency [15]. Several studies have emphasized the role of Nitric Oxide (NO) signaling as a major regulator of vascular tone with its antioxidant, anti-inflammatory and antithrombotic activity. For example, augmenting the production of NO and its bioavailability by Nicorandil has been proposed as a potential treatment in patients with COVID 19. Nicorandil is a vasodilatory agent composed of N-[2-hydroxyethyl]-Nicotinamide Nitrate) used among patients with acute heart failure emergencies. However, it has never been tested in patients with cardiovascular complications resulting from COVID 19 [16]. Moreover, statins are cardio-protective in nature with recent reports showing that they can be beneficial in COVID-19 [17]. An important mechanism via which Statins may improve endothelial function include increasing the production of NO and subsequent vasodilation effect, along with its established major anti-inflammatory and anti-oxidant properties [17]. Vitamin B complex will be used because of the role it plays in cell functioning, energy metabolism, and proper immune function. In addition of its assistance in proper activation of the immune response, reducing pro-inflammatory cytokine levels, improving respiratory function, maintaining endothelial integrity, preventing hypercoagulability and reducing the length of stay in hospital. [18-19-20] Furthermore, eNOS overexpression leads to an increase in NO formation only when the BH4 synthase GTP-cyclohydrolase 1 (GCH-1) is also up-regulated. So, Folic Acid and L-arginine will be given to supplement our patients with BH4 (Tetrahydrobiopterin) [21]. We hypothesize that its administration along with the other previously mentioned agents would improve endothelial function in patients suffering from COVID 19 via a cumulative increase in the bioavailability of NO, and thus improving patients' outcomes

Being tested
Endothelial Protocol
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endothelial ProtocolDrug

    Also called nicorandil, Atorvastatin or home statin, Folic acid, vitamin B complex

    Endothelial Protocol

Study groups in NCT04813471
Study groupRoleWhat they receive
Endothelial Dysfunction ProtocolExperimentalExperimental: 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
Receives: Drug: Endothelial Protocol
Standard of careNo interventionStandard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: will followed up for a total of 28 days

Secondary outcomes (6)
  1. Need for invasive mechanical ventilation

    Measured: F/up for 28 days

  2. Length of ICU stay

    Measured: F/up for 28 days

  3. Length of hospital Stay

    Measured: F/up for 28 days

  4. Length of need of mechanical ventilation

    Measured: F/up for 28 days

  5. All cause mortality

    Measured: F/up for 28 days

  6. Occurrence of side effects

    Measured: F/up for 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2021
  2. Study start20 Jan 2021
  3. Primary completion20 Mar 2021 (estimated)
  4. Study completion30 Apr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open label Randomized Controlled Trial
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04813471
Sponsor's protocol ID
LAUMCRH
Status last verified
Mar 2021
First submitted
22 Mar 2021
Last updated
24 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Endothelial Protocol in people with Covid19 and Endothelial Dysfunction, run by Lebanese American University Medical Center at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kamal Matli, MD (+9613439675, matlikamal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Improvement (time frame: will followed up for a total of 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.

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Clinical Trial NCT04813471 | AzTrials