Telmisartan for Treatment of COVID-19 Patients

NCT04355936 | Completed Phase 4

• 1 other identifier: 2020-001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19 Drug Treatment

Keywords

COVID-19; TELMISARTAN; ARDS

Outcome Measures

Primary Outcomes (1)

• C reactive protein

  Serum C rective protein levels

  Days 5 and 8 after enrollment

Secondary Outcomes (7)

• Admission to intensive care unit (ICU)

  Within 15 and 30 days after randomization

• Occurrence of mechanical ventilation

  Within 15 and 30 days after randomization

• Death

  Within 15 days and 30 days

• Composite occurrence of admission to ICU, mechanical ventilation or death (what occur first)

  Within 15 and 30 days after randomization

• Time from randomization to discharge

  Within 15 days

Study Arms (2)

TELMISARTAN

EXPERIMENTAL

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

NO INTERVENTION

Patients in this group will receive standard care.

Interventions

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

Control arm will receive standard care.

TELMISARTAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratorio Elea Phoenix S.A.: lead
• Carlos R. Rojo, MD: collaborator
• Facultad de Medicina, Universidad de Buenos Aires, UBA: collaborator

Study Sites (2)

Hospital de Clínicas 'José de San Martín', Facultad de Medicina, Universidad de Buenos Aires

Buenos Aires, Buenos Aires F.D., C1120AAR, Argentina

Location

Hospital Español de Buenos Aires

Buenos Aires, 1209, Argentina

Location

Related Publications (2)

• Duarte M, Pelorosso F, Nicolosi LN, Salgado MV, Vetulli H, Aquieri A, Azzato F, Castro M, Coyle J, Davolos I, Criado IF, Gregori R, Mastrodonato P, Rubio MC, Sarquis S, Wahlmann F, Rothlin RP. Telmisartan for treatment of Covid-19 patients: An open multicenter randomized clinical trial. EClinicalMedicine. 2021 Jun 18;37:100962. doi: 10.1016/j.eclinm.2021.100962. eCollection 2021 Jul.

  PMID: 34189447 DERIVED

• Rothlin RP, Vetulli HM, Duarte M, Pelorosso FG. Telmisartan as tentative angiotensin receptor blocker therapeutic for COVID-19. Drug Dev Res. 2020 Nov;81(7):768-770. doi: 10.1002/ddr.21679. Epub 2020 May 1.

  PMID: 32356926 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Francisco Azzato, MD

  Department of Internal Medicine, Hospital de Clínicas 'José de San Martín', Facultad de Medicina, Universidad de Buenos Aires

  STUDY CHAIR

• Mariano Duarte, MD

  Hospital de Clínicas 'José de San Martín', Universidad de Buenos Aires

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to receive standard care or standard care plus Telmisartan 80 mg twice daily upon diagnosis of COVID-19.

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: May 19, 2020
• Primary Completion: November 2, 2020
• Study Completion: November 30, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

AR (2)