Trial Outcomes & Findings for Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients (NCT NCT04360551)

Last Updated: 2023-08-21

Results Overview

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 severe and severe symptoms) of fever, breathing and fatigue severity scale (0 to 4 points for each factor allowing a max score of 12). A WHO scale within the '2' category was then 'fine tuned' as follows: 2.0 (\</=3 symptom points), 2.25 (4-6 symptom points), 2.5 (7-9 symptom points), and 2.75 (10-12 symptom points).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

maximum clinical severity of disease post entry evaluated over the 21 day clinical study

Results posted on

2023-08-21

Participant Flow

Recruitment was advertised generally via physicians and clinics connected with our research center as well as via our medical school's community relations outreach office. Because of the communicable nature of acute COVID-19 infection, the participants were screened, enrolled and underwent their study visits under a portable tent just outside our research clinic on the grounds of the medical school.

No pre-assignment events.

Participant milestones

Participant milestones
Measure	Telmisartan Telmisartan 40 mg po daily x 21 days Telmisartan 40mg: Angiotensin Receptor Blocker (ARB)	Placebo Placebo Placebo: Placebo once daily
Overall Study STARTED	12	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Telmisartan Telmisartan 40 mg po daily x 21 days Telmisartan 40mg: Angiotensin Receptor Blocker (ARB)	Placebo Placebo Placebo: Placebo once daily
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Telmisartan n=12 Participants Telmisartan 40 mg po daily x 21 days Telmisartan 40mg: Angiotensin Receptor Blocker (ARB)	Placebo n=12 Participants Placebo Placebo: Placebo once daily	Total n=24 Participants Total of all reporting groups
Sex: Female, Male Male	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants
Race/Ethnicity, Customized Asian Asian	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Native Hawaiian/Pacific Islander	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Black	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous mean age	35.83 years STANDARD_DEVIATION 12.445 • n=93 Participants	35.83 years STANDARD_DEVIATION 11.991 • n=4 Participants	35.83 years STANDARD_DEVIATION 11.952 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	8 Participants n=4 Participants	12 Participants n=27 Participants
Race/Ethnicity, Customized White	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Race/Ethnicity, Customized More than One Race	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment United States	12 participants n=93 Participants	12 participants n=4 Participants	24 participants n=27 Participants
Clinical Status	2.125 units on a scale n=93 Participants	2.00 units on a scale n=4 Participants	2.00 units on a scale n=27 Participants

PRIMARY outcome

Timeframe: maximum clinical severity of disease post entry evaluated over the 21 day clinical study

Population: Participants with acute COVID infection and symptoms

Outcome measures

Outcome measures
Measure	Telmisartan n=12 Participants Telmisartan 40 mg po daily x 21 days Telmisartan 40mg: Angiotensin Receptor Blocker (ARB)	Placebo n=12 Participants Placebo Placebo: Placebo once daily
Maximum Clinical Severity of Disease Since Entry	2.00 score on a scale Interval 2.0 to 2.0	2.000 score on a scale Interval 2.0 to 2.25

SECONDARY outcome

Timeframe: Through study completion at day 21 of study

Population: All participants entered into the 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

Outcome measures

Outcome measures
Measure	Telmisartan n=12 Participants Telmisartan 40 mg po daily x 21 days Telmisartan 40mg: Angiotensin Receptor Blocker (ARB)	Placebo n=12 Participants Placebo Placebo: Placebo once daily
Number of Adverse Events headache	1 adverse events	1 adverse events
Number of Adverse Events nasal congestion	1 adverse events	1 adverse events
Number of Adverse Events shortness of breath	0 adverse events	1 adverse events
Number of Adverse Events nausea	1 adverse events	0 adverse events
Number of Adverse Events diarrhea	1 adverse events	0 adverse events
Number of Adverse Events chest discomfort	1 adverse events	0 adverse events

Adverse Events

Telmisartan Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Telmisartan Arm n=12 participants at risk Randomized to receive Telmisartan	Placebo Arm n=12 participants at risk Randomized to placebo
Nervous system disorders headache	8.3% 1/12 • Number of events 1 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.	8.3% 1/12 • Number of events 1 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.
Respiratory, thoracic and mediastinal disorders nasal congestion	8.3% 1/12 • Number of events 1 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.	8.3% 1/12 • Number of events 1 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.
Respiratory, thoracic and mediastinal disorders shortness of breath	0.00% 0/12 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.	8.3% 1/12 • Number of events 1 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.
Gastrointestinal disorders nausea	8.3% 1/12 • Number of events 1 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.	0.00% 0/12 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.
Gastrointestinal disorders diarrhea	8.3% 1/12 • Number of events 1 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.	0.00% 0/12 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.
Cardiac disorders chest discomfort	8.3% 1/12 • Number of events 1 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.	0.00% 0/12 • During the 21 days of the study. Same definition of adverse events and serious adverse events were used.

Additional Information

Cecilia M. Shikuma MD

University of Hawaii at Manoa John A Burns School of Medicine

Phone: 808 692-1328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place