Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04510662
Status:
COMPLETED
Last Update Posted:
2023-10-05
First Post:
2020-08-11
Brief Title:
Telmisartan in Respiratory Failure Due to COVID-19
Sponsor:
Abraham Edgar Gracia-Ramos
Organization:
Hospital Regional de Alta Especialidad de Zumpango
Study Overview
Official Title:
Effectiveness and Safety of Telmisartan in Acute Respiratory Failure Due to COVID-19
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR-COVID
Brief Summary:
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 inhibitorsARBs 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 n60 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
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 n60 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None