A Phase 2 interventional study of Telmisartan in COVID-19, Respiratory Insufficiency and Telmisartan, sponsored by Abraham Edgar Gracia-Ramos. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by Abraham Edgar Gracia-Ramos · Phase 2, Interventional, and Treatment
Rationale: The renin-angiotensin-aldosterone system (RAAS) dysregulation may play a central role in the pathophysiology of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection associated acute lung injury (ALI) / acute respiratory distress syndrome (ARDS). In the RAAS, Angiotensin I (Ang I) is converted to angiotensin II (Ang II) by angiotensin converting enzyme (ACE). Ang II mediates vasoconstrictive, pro-inflammatory and pro-oxidative effects through agonism at Ang II type 1 receptor (AT1R). ACE2 converts Ang II to angiotensin 1-7 (Ang1-7), which finally binds to Mas receptor (MasR) and mediates many beneficial actions, including vasodilation and anti-inflammatory, anti-oxidant and antiapoptotic effects. ACE2, a homologue of ACE, is an integral cell membrane protein with a catalytic domain on the extracellular surface exposed to vasoactive peptides. SARS-CoV-2 penetrates the cell through ACE2, and the increase of this receptor (due to the use of ACE inhibitors or angiotensin receptor blockers [ARBs]) may facilitate SARS-CoV-2 infection, which might increase the risk of developing severe and fatal SARS-CoV-2 infection. However, through upregulation of ACE2, ACE inhibitors/ARBs can exert anti-inflammatory and antioxidative effects, which may be beneficial in preventing ALI and ARDS.
Objective: To evaluate the effectiveness and safety of telmisartan in respiratory failure due to COVID-19.
Study design: This is an open label, phase 2 clinical trial. Study population: Adult hospitalized SARS-CoV-2-infected patients (n=60). Intervention: The active-treatment arm will receive telmisartan 40 mg daily and the control arm will receive standard care. Treatment duration will be 14 days or up to hospital discharge \<14 days or occurrence of the primary endpoint if \<14 days.
Main study endpoint: The primary study endpoint is the occurrence within 14 days of randomization of either: 1) Mechanical ventilation or 2) Death.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 66 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with Abraham Edgar Gracia-Ramos as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Randomization:
Exclusion Criteria:
Patients in this group will receive telmisartan 40 mg daily plus standard care.
Drug: Telmisartan
Patients in this group will receive standard care.
Patients in this group will receive telmisartan 40 mg daily plus standard care.
Death
Death is defined as all-cause mortality
Time frame: Within 30 days
Mechanical ventilation
Occurrence of mechanical ventilation
Time frame: Within 14 days
Occurrence of acute kidney injury
Defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of \>30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2
Time frame: Within 14 days
Incidence of hypotension
Incidence of episodes of blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic
Time frame: Within 14 days
Incidence of hypotension requiring vasopressors
Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension
Time frame: Within 14 days
Incidence of Sepsis
Outcome reported as the number of participants in each arm who experience sepsis, defined as the presence of at least 2 of the following clinical criteria together (qSOFA score): respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less
Time frame: Within 14 days
Hospital length of stay
Hospital length of stay (days)
Time frame: Within 14 days
Plan to share: No — There is no plan to share individual participant data with other researchers to avoid misuse of patient information.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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