COVID-19Phase 2NCT04360551

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

A Phase 2 study testing Telmisartan 40mg in people with COVID-19, run by University of Hawaii at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: Telmisartan 40mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2020to 26 Apr 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to provide written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures including self testing of blood pressure daily
Male or non-pregnant female adult ≥18 years of age at time of enrolment.
Has laboratory-confirmed severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection as determined by FDA-approved commercial or public health assay in any specimen collected ideally < 72 hours prior to randomization. Exceptions to the <72 hr inclusion criteria may be made at the discretion of the investigator.
Positive for COVID-19 symptoms: fever defined as a temperature of >100.4 on study screening or self-report of daily fever at home OR shortness of breath of any degree OR fatigue causing greater than minimal interference with usual social \& functional activities
Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study
Able to easily swallow pills

Who cannot join

Immediate need for hospitalization on screening
Systolic blood pressure less than 100 mmHg
Self-reported presence of chronic kidney disease or requiring dialysis
Self-reported history of liver failure or untreated hepatitis B or C
Pregnancy or breast feeding
Allergy to the study medication

Show all 14Show fewer

Current use of angiotensin receptor blocker (ARB) or angiotensin converting enzyme (ACE) Inhibitor medications. Other blood pressure medications will be permitted in the systolic BP is higher than 90 mmHg
Prior reaction or intolerance to ARB or ACE Inhibitor
Use of aliskiren in patients with diabetes
Current use of and on-going need for lithium, digoxin, potassium sparing diuretics such as spironolactone
Current use of and need for potassium supplements
Current or past participation in a research study within 12 weeks prior to the Screening Visit unless cleared by Study Team
Inability to drive safely for study visits
Subjects, who, in the opinion of the investigator, are unable to comply with the protocol evaluation, or for whom study participation may not be advisable

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Hawaii - Manoa, John A Burns School of Medicine UH Clinics at Kakaako
Honolulu, Hawaii, 96813

Other trials in United States

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients

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.

Conditions: COVID-19
Being tested: Telmisartan 40mg, Placebo
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telmisartan 40mgDrug
Angiotensin Receptor Blocker (ARB)
PlaceboDrug
Placebo once daily

Study groups in NCT04360551
Study group	Role	What they receive
Telmisartan	Experimental	Telmisartan 40 mg po daily x 21 days Receives: Drug: Telmisartan 40mg
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Clinical Severity of Disease Since Entry
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).
Measured: maximum clinical severity of disease post entry evaluated over the 21 day clinical study

Secondary outcomes (1)

Number of Adverse Events
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
Measured: Through study completion at day 21 of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202026 Apr 2022

First posted24 Apr 2020
Study start1 Jul 2020
Primary completion26 Apr 2022
Study completion26 Apr 2022

Why it stopped: Decrease in COVID-19 cases locally

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04360551
Sponsor's protocol ID: H051
Other IDs: U54MD007601-34S3
Status last verified: Aug 2023
First submitted: 21 Apr 2020
Last updated: 21 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients
ClinicalTrials.gov ID: NCT04360551
Acronym / sponsor ID: H051
Conditions: COVID-19
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Decrease in COVID-19 cases locally
Enrolment: 24 participants (actual)
Lead sponsor: University of HawaiiUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 1 Jul 2020 (actual)
Primary completion: 26 Apr 2022 (actual)
Study completion: 26 Apr 2022 (actual)
First posted: 24 Apr 2020 (actual)
Results: Posted 21 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Telmisartan	Experimental	Drug: Telmisartan 40mgTelmisartan 40 mg po daily x 21 days
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Able to provide written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures including self testing of blood pressure daily
Male or non-pregnant female adult ≥18 years of age at time of enrolment.
Has laboratory-confirmed severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) infection as determined by FDA-approved commercial or public health assay in any specimen collected ideally < 72 hours prior to randomization. Exceptions to the <72 hr inclusion criteria may be made at the discretion of the investigator.
Positive for COVID-19 symptoms: fever defined as a temperature of >100.4 on study screening or self-report of daily fever at home OR shortness of breath of any degree OR fatigue causing greater than minimal interference with usual social \& functional activities

Key exclusion criteria (14 listed)

Immediate need for hospitalization on screening
Systolic blood pressure less than 100 mmHg
Self-reported presence of chronic kidney disease or requiring dialysis
Self-reported history of liver failure or untreated hepatitis B or C
Pregnancy or breast feeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Telmisartan 40mgAngiotensin Receptor Blocker (ARB)	Drug	Telmisartan
PlaceboPlacebo once daily	Drug	Placebo

Primary outcome

Maximum Clinical Severity of Disease Since Entry
Time frame: 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 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).

1 secondary outcome

Number of Adverse Events
Time frame: Through study completion at day 21 of study

Results and safety

Results posted to the registry on 21 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Telmisartan	12	11
Placebo	12	12

Primary outcome: Maximum Clinical Severity of Disease Since Entry

Time frame: maximum clinical severity of disease post entry evaluated over the 21 day clinical study. Median (Inter-Quartile Range). Unit: score on a scale

Measure	Telmisartan n = 12	Placebo n = 12
Value	2.00 (2.00 to 2.00)	2.000 (2.00 to 2.25)

Telmisartan vs Placebo: p = 0.244, Wilcoxon (Mann-Whitney)

Population analysed: Participants with acute COVID infection and symptoms

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During the 21 days of the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Telmisartan Arm	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Placebo Arm	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Limitations and caveats (from the sponsor): The number of individuals involved in the study was extremely small. The study was terminated early because the number of infections in the community substantially decreased. As an outpatient study, the study only involved individuals with mild to moderate COVID-19 infection, as those severely ill with acute COVID-19 infections may have been hospitalized.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cecilia M Shikuma, MD principal investigator

University of Hawaii at Manoa John A Burns School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Telmisartan 40mg in people with COVID-19, run by University of Hawaii at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Clinical Severity of Disease Since Entry (time frame: maximum clinical severity of disease post entry evaluated over the 21 day clinical study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04360551.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.