NCT04360551

Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients

Terminated Phase 2 Results posted Last updated 21 August 2023

What this trial tests

Phase 2 trial testing Telmisartan 40mg in COVID-19 in 24 participants. Terminated before completion.

Timeline

1 July 2020

Primary endpoint
26 April 2022

26 April 2022

Quick facts

Lead sponsor	University of Hawaii
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	24
Start date	1 July 2020
Primary completion	26 April 2022
Estimated completion	26 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Telmisartan 40mg — full drug profile →
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

University of Hawaii

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Maximum Clinical Severity of Disease Since Entry Primary · maximum clinical severity of disease post entry evaluated over the 21 day clinical study

We utilized the World Health Organization (WHO) COVID-19 7-point ordinal scale: 1 (not hospitalized, no limitations on activities), 2 (not hospitalized limitation on activities); 3 (hospitalized, not requiring oxygen); 4 (hospitalized and requiring oxygen); 5 (hospitalized, on non-invasive ventilation or high flow oxygen devices); 6 (hospitalized, on invasive mechanical ventilation or ECMO) and 7 (death). A symptom scale was devised to allow 'fine tuning' within the 2.0 WHO category of 'not hospitalized but limitation on activities' based on severity (no symptoms, mild, moderate, moderately s

Group	Value	95% CI
Telmisartan	2.00	2.00 – 2.00
Placebo	2.000	2.00 – 2.25

Number of Adverse Events Secondary · Through study completion at day 21 of study

Number of adverse events grade 2 and above utilizing the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0, November 2014

headache

Group	Value	95% CI
Telmisartan	1
Placebo	1

nasal congestion

Group	Value	95% CI
Telmisartan	1
Placebo	1

shortness of breath

Group	Value	95% CI
Telmisartan	0
Placebo	1

nausea

Group	Value	95% CI
Telmisartan	1
Placebo	0

diarrhea

Group	Value	95% CI
Telmisartan	1
Placebo	0

chest discomfort

Group	Value	95% CI
Telmisartan	1
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: During the 21 days of the study.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Telmisartan Arm

Serious: 0/12 (0%)

Deaths: 0/12

Placebo Arm

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (6 terms — click to expand)

Reaction	System	Telmisartan Arm	Placebo Arm
headache	Nervous system disorders	—	—
nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
shortness of breath	Respiratory, thoracic and mediastinal disorders	—	—
nausea	Gastrointestinal disorders	—	—
diarrhea	Gastrointestinal disorders	—	—
chest discomfort	Cardiac disorders	—	—

Data from ClinicalTrials.gov NCT04360551 adverse events section.

Sponsor's own description

This study will enroll 40 symptomatic outpatients tested positive for Coronavirus 2019 (COVID-19). Patients to be randomized 1:1 to Telmisartan (40 mg) vs placebo to be administered orally once daily x 21 days. Daily, the study patients will be asked to keep a record of the severity of their fever, dyspnea and fatigue and take their blood pressure (BP) and temperature. Study visits to occur on day 1 (entry), day 4, day 10 and day 21. Oro-pharyngeal swabs, and approximately 25 cc of blood will be collected at each study visit for safety labs and for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of inflammation, coagulation and fibrosis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. ACE2 imbalance as a key player for the poor outcomes in COVID-19 patients with age-related comorbidities - Role of gut microbiota dysbiosis.
   Viana SD, Nunes S, Reis F. · · 2020 · cited 122× · PMID 32683039 · DOI 10.1016/j.arr.2020.101123
2. Renin-Angiotensin System Inhibitors in Patients With COVID-19: A Meta-Analysis of Randomized Controlled Trials Led by the International Society of Hypertension.
   Gnanenthiran SR, Borghi C, Burger D, Caramelli B, et al · · 2022 · cited 37× · PMID 36000426 · DOI 10.1161/jaha.122.026143
3. Novel therapeutic approaches for treatment of COVID-19.
   Hossein-Khannazer N, Shokoohian B, Shpichka A, Aghdaei HA, et al · · 2020 · cited 36× · PMID 32494931 · DOI 10.1007/s00109-020-01927-6
4. The Role of Renin-Angiotensin-Aldosterone System in the Heart and Lung: Focus on COVID-19.
   Mascolo A, Scavone C, Rafaniello C, De Angelis A, et al · · 2021 · cited 34× · PMID 33959029 · DOI 10.3389/fphar.2021.667254
5. Quantitative Structure-Activity Relationship Machine Learning Models and their Applications for Identifying Viral 3CLpro- and RdRp-Targeting Compounds as Potential Therapeutics for COVID-19 and Related Viral Infections.
   Ivanov J, Polshakov D, Kato-Weinstein J, Zhou Q, et al · · 2020 · cited 32× · PMID 33134697 · DOI 10.1021/acsomega.0c03682
6. Renin-Angiotensin System and Coronavirus Disease 2019: A Narrative Review.
   Mascolo A, Scavone C, Rafaniello C, Ferrajolo C, et al · · 2020 · cited 32× · PMID 32850989 · DOI 10.3389/fcvm.2020.00143
7. ACE2 as a Therapeutic Target for COVID-19; its Role in Infectious Processes and Regulation by Modulators of the RAAS System.
   Michaud V, Deodhar M, Arwood M, Al Rihani SB, et al · · 2020 · cited 29× · PMID 32635289 · DOI 10.3390/jcm9072096
8. Cancer, immune suppression and Coronavirus Disease-19 (COVID-19): Need to manage drug safety (French Society for Oncology Pharmacy [SFPO] guidelines).
   Slimano F, Baudouin A, Zerbit J, Toulemonde-Deldicque A, et al · · 2020 · cited 29× · PMID 32623296 · DOI 10.1016/j.ctrv.2020.102063