Telmisartan for Treatment of COVID-19 Patients

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorio Elea Phoenix S.A.; Laboratorio Elea S.A.C.I.F. y A.
• Collaborators: Carlos R. Rojo, MD; Facultad de Medicina, Universidad de Buenos Aires, UBA
• Treatments: Telmisartan

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