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Telmisartan for Treatment of COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04355936
Recruitment Status : Recruiting
First Posted : April 21, 2020
Last Update Posted : May 27, 2020
Sponsor:
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 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 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 1, 8 and 15 after enrollment ]
    Serum C rective protein levels


Secondary Outcome Measures :
  1. Number of opacified quadrants on lung Rx [ Time Frame: Days 1, 8 and 15 after enrollment ]
    Number of opacified quadrants on lung Rx

  2. Occurrence of mechanical ventilation [ Time Frame: Within 15 days ]
  3. Intensive care unit admission [ Time Frame: Within 15 days ]
    Occurrence of ICU admission and time to admission

  4. Death [ Time Frame: Within 15 days, 30 days, 90 days ]
    All-cause mortality; and time to all-cause mortality

  5. LDH [ Time Frame: Days 1, 8 and 15 after enrollment ]
    Lactate deshidrogenase serum levels

  6. Troponin [ Time Frame: Days 1, 8 and 15 after enrollment ]
    Troponin serum levels

  7. Time to mechanical ventilation [ Time Frame: Within 15 days ]

Other Outcome Measures:
  1. Active urinary sediment [ Time Frame: Days 1, 8 and 15 after enrollment ]
    Normal/abnormal



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:

  • Aged 18 years or older
  • Confirmed diagnosis of COVID-19 by PCR test

Exclusion Criteria:

  • Hospitalization in the previous 6 months
  • Pregnancy
  • Lactancy
  • Major allergy to any AT1 receptor blocker
  • Sistolic arterial pressurelower than 100 mmHg
  • Serum potassium higher than 5.5 meq/l
  • AST/ALT higher than 3x normal
  • Serum Creatinine higher than 3 mg/dl.
  • Patient is taking 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


Contacts
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Contact: Rodolfo P Rothlin, MD +54-911-6961-6705 safc@ama-med.org.ar
Contact: Mariano Duarte, MD +54 9 11 6643 6278 drmarianoduarte@hotmail.com

Locations
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Argentina
Hospital de Clínicas 'José de San Martín', Facultad de Medicina, Universidad de Buenos Aires Recruiting
Buenos Aires, Ciudad De Buenos Aires, Argentina, C1120AAR
Contact: Rodolfo P Rothlin, MD    +5411-69616705    saftc@ama-med.org.ar   
Contact: Mariano Duarte, MD    +54 9 11 6643 6278    drmarianoduarte@hotmail.com   
Principal Investigator: Mariano Duarte, MD         
Sponsors and Collaborators
Laboratorio Elea Phoenix S.A.
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: May 27, 2020
Last Verified: May 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