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Telmisartan for Treatment of COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04355936
Recruitment Status : Completed
First Posted : April 21, 2020
Last Update Posted : December 24, 2020
Sponsor:
Collaborators:
Carlos R. Rojo, MD
Facultad de Medicina, Universidad de Buenos Aires, UBA
Information provided by (Responsible Party):
Laboratorio Elea Phoenix S.A.

Brief Summary:
In late 2019, a new coronavirus emerged in Wuhan Province, China, causing lung complications similar to those produced by the SARS coronavirus in the 2002-2003 epidemic. This new disease was named COVID-19 and the causative virus SARS-CoV-2. The SARS-CoV-2 virus, enters the airway and binds, by means of the S protein on its surface to the membrane protein ACE2 in type 2 alveolar cells. The S protein-ACE2 complex is internalized by endocytosis leading to a partial decrease or total loss of the enzymatic function ACE2 in the alveolar cells and in turn increasing the tissue concentration of pro-inflammatory angiotensin II by decreasing its degradation and reducing the concentration of its physiological antagonist angiotensin 1-7. High levels of angiotensin II on the lung interstitium can promote apoptosis initiating an inflammatory process with release of proinflammatory cytokines, establishing a self-powered cascade, leading eventually to ARDS. It has recently been proposed the tentative use of agents such as losartan and telmisartan as alternative options for treating COVID-19 patients prior to development of ARDS. The present study is an open-label randomized phase II clinical trial for the evaluation of telmisartan in COVID-19 patients. Briefly, patients with confirmed diagnosis of SARS-CoV-2, will be randomized to receive 80 mg/12h of telmisartan plus standard care or standard care alone aand will be monitored for development of systemic inflammation and acute respiratory distress syndrome. Other variables regarding lung function and cardiovascular function will also be evaluated.

Condition or disease Intervention/treatment Phase
COVID-19 Drug Treatment Drug: Telmisartan arm will receive 80 mg Telmisartan twice daily plus standard care. Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive standard care or standard care plus Telmisartan 80 mg twice daily upon diagnosis of COVID-19.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telmisartan for Treatment of COVID-19 Patients: an Open Label Randomized Trial
Actual Study Start Date : May 19, 2020
Actual Primary Completion Date : November 2, 2020
Actual Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Telmisartan

Arm Intervention/treatment
Experimental: TELMISARTAN
Patients in this group will receive 80 mg Telmisartan twice daily plus standard care.
Drug: Telmisartan arm will receive 80 mg Telmisartan twice daily plus standard care.
Control arm will receive standard care.

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



Primary Outcome Measures :
  1. C reactive protein [ Time Frame: Days 5 and 8 after enrollment ]
    Serum C rective protein levels


Secondary Outcome Measures :
  1. Admission to intensive care unit (ICU) [ Time Frame: Within 15 and 30 days after randomization ]
  2. Occurrence of mechanical ventilation [ Time Frame: Within 15 and 30 days after randomization ]
  3. Death [ Time Frame: Within 15 days and 30 days ]
    All-cause mortality; and time to all-cause mortality

  4. Composite occurrence of admission to ICU, mechanical ventilation or death (what occur first) [ Time Frame: Within 15 and 30 days after randomization ]
  5. Time from randomization to discharge [ Time Frame: Within 15 days ]
  6. Proportion of patients not requiring supplemental oxygen at day 15 [ Time Frame: Within 15 days ]
  7. Significative differences in serum lactate dehydrogenase [ Time Frame: Days 5 and 8 ]
    Troponin serum levels



Information from the National Library of Medicine

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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:

  • Aged 18 years or older
  • Confirmed diagnosis of COVID-19 by PCR test
  • Hospitalization for COVID-19
  • Illness symptoms beginning 4 days or less prior to randomization

Exclusion Criteria:

  • Admitted to ICU prior to randomization
  • Illness symptoms beginning more than 4 days prior to randomization
  • Pregnancy
  • Breast feeding
  • Major hypersensibility to angiotensin receptor blockers (ARBs)
  • Systolic blood pressure < 100mmHg
  • Potassium greater than 5.5 mEq/L
  • AST and/or ALT > 3 times the upper limit of normal
  • Serum creatinine higher than 3 mg/dL
  • Current treatment with angiotensin converting enzyme inhibitor (ACEi) or ARB

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): NCT04355936


Locations
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Argentina
Hospital de Clínicas 'José de San Martín', Facultad de Medicina, Universidad de Buenos Aires
Buenos Aires, Ciudad De Buenos Aires, Argentina, C1120AAR
Hospital Español de Buenos Aires
Ciudad Autonoma de Buenos Aires, Argentina, 1209
Sponsors and Collaborators
Laboratorio Elea Phoenix S.A.
Carlos R. Rojo, MD
Facultad de Medicina, Universidad de Buenos Aires, UBA
Investigators
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Study Chair: Francisco Azzato, MD Department of Internal Medicine, Hospital de Clínicas 'José de San Martín', Facultad de Medicina, Universidad de Buenos Aires
Principal Investigator: Mariano Duarte, MD Hospital de Clínicas 'José de San Martín', Universidad de Buenos Aires
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laboratorio Elea Phoenix S.A.
ClinicalTrials.gov Identifier: NCT04355936    
Other Study ID Numbers: 2020-001
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020

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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 Laboratorio Elea Phoenix S.A.:
COVID-19
TELMISARTAN
ARDS
Additional relevant MeSH terms:
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Telmisartan
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action