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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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.
Lebanon1 site, 1 recruiting
- Recruiting
LAUMCRH
Beirut, 000000
Georges Ghanem, MD, 9611200800, georges.ghanem@laumcrh.com
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
- Conditions
- Covid19, Endothelial Dysfunction
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Endothelial Protocol |
| Standard of care | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Need for invasive mechanical ventilation
Measured: F/up for 28 days
Length of ICU stay
Measured: F/up for 28 days
Length of hospital Stay
Measured: F/up for 28 days
Length of need of mechanical ventilation
Measured: F/up for 28 days
All cause mortality
Measured: F/up for 28 days
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.
- First posted24 Mar 2021
- Study start20 Jan 2021
- Primary completion20 Mar 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Lebanese American University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamal Matli, Lebanese American University Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Endothelial Dysfunction in Critically Ill COVID-19 Patients at the Lebanese American University Medical Center- Rizk Hospital
- ClinicalTrials.gov ID
- NCT04813471
- Acronym / sponsor ID
- LAUMCRH
- Conditions
- Covid19, Endothelial Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Lebanese American University Medical CenterUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 20 Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Endothelial Dysfunction Protocol | Experimental | Drug: Endothelial ProtocolExperimental: 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 |
| Standard of care | No intervention | –Standard of Care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endothelial ProtocolAlso: nicorandil, Atorvastatin or home statin, Folic acid, vitamin B complexEndothelial Protocol | Drug | Endothelial Dysfunction Protocol |
Primary outcome
Clinical Improvement
Time frame: will followed up for a total of 28 days
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
6 secondary outcomes
Need for invasive mechanical ventilation
Time frame: F/up for 28 days
Length of ICU stay
Time frame: F/up for 28 days
Length of hospital Stay
Time frame: F/up for 28 days
Length of need of mechanical ventilation
Time frame: F/up for 28 days
All cause mortality
Time frame: F/up for 28 days
Occurrence of side effects
Time frame: F/up for 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.