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Telmisartan for Treatment of COVID-19 Patients

NCT04355936 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-12-24

No results posted yet for this study

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.

Conditions

  • COVID-19 Drug Treatment

Interventions

DRUG

Telmisartan arm will receive 80 mg Telmisartan twice daily plus standard care.

Control arm will receive standard care.

Sponsors & Collaborators

  • Carlos R. Rojo, MD

    collaborator UNKNOWN

  • Facultad de Medicina, Universidad de Buenos Aires, UBA

    collaborator UNKNOWN

  • Laboratorio Elea Phoenix S.A.

    lead INDUSTRY

Principal Investigators

  • Francisco Azzato, MD · Department of Internal Medicine, Hospital de Clínicas 'José de San Martín', Facultad de Medicina, Universidad de Buenos Aires

  • Mariano Duarte, MD · Hospital de Clínicas 'José de San Martín', Universidad de Buenos Aires

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-19
Primary Completion
2020-11-02
Completion
2020-11-30

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04355936 on ClinicalTrials.gov