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Telmisartan in Respiratory Failure Due to COVID-19 (STAR-COVID)

Primary Purpose

COVID-19, Respiratory Insufficiency, Telmisartan

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Telmisartan
Sponsored by
Abraham Edgar Gracia-Ramos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, telmisartan, respiratory failure, respiratory distress syndrome, adult

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age greater than or equal to 18 years of age.
  • Admitted to the Hospital Regional de Alta Especialidad de Zumpango.
  • Confirmed SARS-CoV-2 infection with either: positive laboratory test for SARS-CoV-2; or positive CT thorax diagnostic for SARS-CoV-2 infection according to the prevailing criteria.
  • Hypoxic respiratory failure: SpO2 ≤94% on room OR tachypnea (respiratory rate ≥22 breaths/min).

Randomization:

  • Within 24 hours of confirmed in-hospital SARS-CoV-2 infection diagnosis OR
  • within 24 hours of hospital admission in case of pre-hospital confirmed SARS-CoV-2 infection.
  • In case there is a lack of laboratory tests for SARS-CoV-2 in a potentially eligible patient, a positive laboratory test for SARS-CoV-2 will be no longer required. In that case, the potentially eligible patient needs to meet the prevailing criteria for the diagnosis of SARS-CoV-2 infection, such as typical abnormalities on pulmonary CT in the setting of high clinical suspicion of SARS-CoV-2 infection.

Exclusion Criteria:

  • Admitted to ICU prior to randomization.
  • Currently taking an an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB).
  • Use of other investigational drugs at the time of enrollment
  • Prior reaction or intolerance to an ARB; or severe intolerance to an ACEi, defined as angio-oedema requiring medical intervention.
  • Systolic blood pressure < 105 mmHg or diastolic blood pressure <65mmHg.
  • Potassium greater than 5.5 mEq/L within 4 weeks of study enrollment.
  • Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 within 4 weeks of study initiation.
  • A known history of renal artery stenosis.
  • AST and/or ALT > 3 times the upper limit of normal within 4 weeks of study enrollment.
  • Severe liver dysfunction (Child-Pugh score C), biliary cirrhosis or cholestasis.
  • Severe volume depletion or severe acute kidney injury.
  • Inability to obtain informed consent.
  • Pregnancy or breastfeeding.

Sites / Locations

  • Hospital Regional de Alta Especialidad de Zumpango

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telmisartan

Control

Arm Description

Patients in this group will receive telmisartan 40 mg daily plus standard care.

Patients in this group will receive standard care.

Outcomes

Primary Outcome Measures

Death
Death is defined as all-cause mortality
Mechanical ventilation
Occurrence of mechanical ventilation

Secondary Outcome Measures

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
Incidence of hypotension
Incidence of episodes of blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic
Incidence of hypotension requiring vasopressors
Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension
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
Hospital length of stay
Hospital length of stay (days)

Full Information

First Posted
August 11, 2020
Last Updated
October 3, 2023
Sponsor
Abraham Edgar Gracia-Ramos
Collaborators
National Polytechnic Institute, Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04510662
Brief Title
Telmisartan in Respiratory Failure Due to COVID-19
Acronym
STAR-COVID
Official Title
Effectiveness and Safety of Telmisartan in Acute Respiratory Failure Due to COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abraham Edgar Gracia-Ramos
Collaborators
National Polytechnic Institute, Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Respiratory Insufficiency, Telmisartan, Respiratory Distress Syndrome, Adult
Keywords
COVID-19, telmisartan, respiratory failure, respiratory distress syndrome, adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telmisartan
Arm Type
Experimental
Arm Description
Patients in this group will receive telmisartan 40 mg daily plus standard care.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in this group will receive standard care.
Intervention Type
Drug
Intervention Name(s)
Telmisartan
Intervention Description
Patients in this group will receive telmisartan 40 mg daily plus standard care.
Primary Outcome Measure Information:
Title
Death
Description
Death is defined as all-cause mortality
Time Frame
Within 30 days
Title
Mechanical ventilation
Description
Occurrence of mechanical ventilation
Time Frame
Within 14 days
Secondary Outcome Measure Information:
Title
Occurrence of acute kidney injury
Description
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
Title
Incidence of hypotension
Description
Incidence of episodes of blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic
Time Frame
Within 14 days
Title
Incidence of hypotension requiring vasopressors
Description
Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension
Time Frame
Within 14 days
Title
Incidence of Sepsis
Description
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
Title
Hospital length of stay
Description
Hospital length of stay (days)
Time Frame
Within 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 18 years of age. Admitted to the Hospital Regional de Alta Especialidad de Zumpango. Confirmed SARS-CoV-2 infection with either: positive laboratory test for SARS-CoV-2; or positive CT thorax diagnostic for SARS-CoV-2 infection according to the prevailing criteria. Hypoxic respiratory failure: SpO2 ≤94% on room OR tachypnea (respiratory rate ≥22 breaths/min). Randomization: Within 24 hours of confirmed in-hospital SARS-CoV-2 infection diagnosis OR within 24 hours of hospital admission in case of pre-hospital confirmed SARS-CoV-2 infection. In case there is a lack of laboratory tests for SARS-CoV-2 in a potentially eligible patient, a positive laboratory test for SARS-CoV-2 will be no longer required. In that case, the potentially eligible patient needs to meet the prevailing criteria for the diagnosis of SARS-CoV-2 infection, such as typical abnormalities on pulmonary CT in the setting of high clinical suspicion of SARS-CoV-2 infection. Exclusion Criteria: Admitted to ICU prior to randomization. Currently taking an an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB). Use of other investigational drugs at the time of enrollment Prior reaction or intolerance to an ARB; or severe intolerance to an ACEi, defined as angio-oedema requiring medical intervention. Systolic blood pressure < 105 mmHg or diastolic blood pressure <65mmHg. Potassium greater than 5.5 mEq/L within 4 weeks of study enrollment. Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 within 4 weeks of study initiation. A known history of renal artery stenosis. AST and/or ALT > 3 times the upper limit of normal within 4 weeks of study enrollment. Severe liver dysfunction (Child-Pugh score C), biliary cirrhosis or cholestasis. Severe volume depletion or severe acute kidney injury. Inability to obtain informed consent. Pregnancy or breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Edgar Gracia-Ramos, MD MSc
Organizational Affiliation
Hospital Regional de Alta Especialidad de Zumpango
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional de Alta Especialidad de Zumpango
City
Zumpango
State/Province
Estado De Mexico
ZIP/Postal Code
55600
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data with other researchers to avoid misuse of patient information.
Citations:
PubMed Identifier
32356926
Citation
Rothlin RP, Vetulli HM, Duarte M, Pelorosso FG. Telmisartan as tentative angiotensin receptor blocker therapeutic for COVID-19. Drug Dev Res. 2020 Nov;81(7):768-770. doi: 10.1002/ddr.21679. Epub 2020 May 1.
Results Reference
background
PubMed Identifier
32376099
Citation
Sanchis-Gomar F, Lavie CJ, Perez-Quilis C, Henry BM, Lippi G. Angiotensin-Converting Enzyme 2 and Antihypertensives (Angiotensin Receptor Blockers and Angiotensin-Converting Enzyme Inhibitors) in Coronavirus Disease 2019. Mayo Clin Proc. 2020 Jun;95(6):1222-1230. doi: 10.1016/j.mayocp.2020.03.026. Epub 2020 Apr 4.
Results Reference
background
PubMed Identifier
32208485
Citation
Patel AB, Verma A. COVID-19 and Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers: What Is the Evidence? JAMA. 2020 May 12;323(18):1769-1770. doi: 10.1001/jama.2020.4812. No abstract available.
Results Reference
background
PubMed Identifier
32242890
Citation
Bavishi C, Maddox TM, Messerli FH. Coronavirus Disease 2019 (COVID-19) Infection and Renin Angiotensin System Blockers. JAMA Cardiol. 2020 Jul 1;5(7):745-747. doi: 10.1001/jamacardio.2020.1282. No abstract available.
Results Reference
background
PubMed Identifier
32227760
Citation
Vaduganathan M, Vardeny O, Michel T, McMurray JJV, Pfeffer MA, Solomon SD. Renin-Angiotensin-Aldosterone System Inhibitors in Patients with Covid-19. N Engl J Med. 2020 Apr 23;382(17):1653-1659. doi: 10.1056/NEJMsr2005760. Epub 2020 Mar 30. No abstract available.
Results Reference
background

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Telmisartan in Respiratory Failure Due to COVID-19

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