Status:
COMPLETED
Telmisartan in Respiratory Failure Due to COVID-19
Lead Sponsor:
Abraham Edgar Gracia-Ramos
Collaborating Sponsors:
National Polytechnic Institute, Mexico
Conditions:
COVID-19
Respiratory Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 associ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04510662
Start Date
August 12 2020
End Date
May 25 2021
Last Update
October 5 2023
Active Locations (1)
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1
Hospital Regional de Alta Especialidad de Zumpango
Zumpango, State of Mexico, Mexico, 55600