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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510662
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
National Polytechnic Institute, Mexico
Information provided by (Responsible Party):
Abraham Edgar Gracia-Ramos, Hospital Regional de Alta Especialidad de Zumpango

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.


Condition or disease Intervention/treatment Phase
COVID-19 Respiratory Insufficiency Telmisartan Respiratory Distress Syndrome, Adult Drug: Telmisartan Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Telmisartan in Acute Respiratory Failure Due to COVID-19
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021


Arm Intervention/treatment
Experimental: Telmisartan
Patients in this group will receive telmisartan 40 mg daily plus standard care.
Drug: Telmisartan
Patients in this group will receive telmisartan 40 mg daily plus standard care.

No Intervention: Control
Patients in this group will receive standard care.



Primary Outcome Measures :
  1. Death [ Time Frame: Within 30 days ]
    Death is defined as all-cause mortality

  2. Mechanical ventilation [ Time Frame: Within 14 days ]
    Occurrence of mechanical ventilation


Secondary Outcome Measures :
  1. Occurrence of acute kidney injury [ Time Frame: Within 14 days ]
    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

  2. Incidence of hypotension [ Time Frame: Within 14 days ]
    Incidence of episodes of blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic

  3. Incidence of hypotension requiring vasopressors [ Time Frame: Within 14 days ]
    Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension

  4. Incidence of Sepsis [ Time Frame: Within 14 days ]
    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

  5. Hospital length of stay [ Time Frame: Within 14 days ]
    Hospital length of stay (days)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510662


Contacts
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Contact: Maria Jose Pecero-Hidalgo, MD +52 5544504800 mariajose.phgo@gmail.com

Locations
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Mexico
Hospital Regional de Alta Especialidad de Zumpango Recruiting
Zumpango, Estado De Mexico, Mexico, 55600
Contact: Maria Jose Pecero Hidalgo, MD    +52 5544504800    mariajose.phgo@gmail.com   
Principal Investigator: Abraham Edgar Gracia-Ramos, MD MSc         
Sponsors and Collaborators
Abraham Edgar Gracia-Ramos
National Polytechnic Institute, Mexico
Investigators
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Principal Investigator: Abraham Edgar Gracia-Ramos, MD MSc Hospital Regional de Alta Especialidad de Zumpango
Publications:
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Responsible Party: Abraham Edgar Gracia-Ramos, Physician of the Department of Internal Medicine, Hospital Regional de Alta Especialidad de Zumpango
ClinicalTrials.gov Identifier: NCT04510662    
Other Study ID Numbers: CI/HRAEZ2020/05
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data with other researchers to avoid misuse of patient information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abraham Edgar Gracia-Ramos, Hospital Regional de Alta Especialidad de Zumpango:
COVID-19
telmisartan
respiratory failure
respiratory distress syndrome, adult
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Pulmonary Valve Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Lung Injury
Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action