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COVID-19Phase 2STAR-COVIDNCT04510662

Telmisartan in Respiratory Failure Due to COVID-19

A Phase 2 study testing Telmisartan in people with COVID-19 and Respiratory Insufficiency, run by Abraham Edgar Gracia-Ramos at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Respiratory Insufficiency, Telmisartan
What is being tested?
Telmisartan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteMexico
Study dates
12 Aug 2020to 25 May 2021
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital Regional de Alta Especialidad de Zumpango

    Zumpango, State of Mexico, 55600

Other trials in Mexico

About this study

Official title: Effectiveness and Safety of Telmisartan in Acute Respiratory Failure Due to COVID-19

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.

Read more

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.

Being tested
Telmisartan
Keywords
COVID-19, telmisartan, respiratory failure, respiratory distress syndrome, adult
Medical subject headings
COVID-19, Respiratory Insufficiency, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TelmisartanDrug

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

Study groups in NCT04510662
Study groupRoleWhat they receive
TelmisartanExperimentalPatients in this group will receive telmisartan 40 mg daily plus standard care.
Receives: Drug: Telmisartan
ControlNo interventionPatients in this group will receive standard care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death

    Death is defined as all-cause mortality

    Measured: Within 30 days

  2. Mechanical ventilation

    Occurrence of mechanical ventilation

    Measured: Within 14 days

Secondary outcomes (5)

  1. 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

    Measured: Within 14 days

  2. Incidence of hypotension

    Incidence of episodes of blood pressure less than 90 mm Hg systolic or 60 mm Hg diastolic

    Measured: Within 14 days

  3. Incidence of hypotension requiring vasopressors

    Outcome reported as the number of participants in each arm requiring the use of vasopressors for hypotension

    Measured: Within 14 days

  4. 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

    Measured: Within 14 days

  5. Hospital length of stay

    Hospital length of stay (days)

    Measured: Within 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2020
  2. Study start12 Aug 2020
  3. Primary completion15 May 2021
  4. Study completion25 May 2021

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04510662
Sponsor's protocol ID
CI/HRAEZ2020/05
Acronym
STAR-COVID
Status last verified
Oct 2023
First submitted
11 Aug 2020
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share individual participant data with other researchers to avoid misuse of patient information.

Publications

  • 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.

    PubMed 32356926

  • 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.

    PubMed 32376099

  • 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.

    PubMed 32208485

  • 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.

    PubMed 32242890

  • 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.

    PubMed 32227760

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telmisartan in people with COVID-19 and Respiratory Insufficiency, run by Abraham Edgar Gracia-Ramos at 1 site in Mexico.

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 8 inclusion and 13 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: finished, as of the sponsor's last update on 5 Oct 2023. 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 Mexico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death (time frame: Within 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04510662, which also lists 5 linked publications.

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 5 Oct 2023.

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