Covid19Phase 2INTELNCT04715763
INvestigating TELmisartin Study
A Phase 2 study testing Telmisartan Oral Product in people with Covid19, run by University of Hawaii at 1 site in United States.
Trial summary
This study will enroll 40 inpatients hospitalized for COVID-19 at Queens' Medical Center. Participants will be randomized 1:1 to Telmisartan (80 mg) vs placebo to be administered orally once daily x 21 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Telmisartan Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 26 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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.
- Within 72 hours of initial hospitalization for acute COVID-19 disease management
- Male or non-pregnant female adult ≥18 years of age at time of enrolment.
- Able to easily swallow pills
Who cannot join
- Systolic blood pressure less than 100 mmHg
- Self-reported history of decompensated liver failure
- Pregnancy or breast feeding
- Allergy to the study medication
- Current use of ARB, ACE inhibitors, or angiotensin receptor/neprilysin inhibitors (ARNIs). Blood pressure medications in other classes will be permitted as long as the systolic BP is >100 mmHg
- Currently receiving vasopressors for hypotension
Show all 15Show fewer
- Prior reaction or intolerance to ARB, ACE Inhibitor or ANRI for whom study participation would not be advisable in the opinion of the study team
- Current use of and on-going need for aliskiren, lithium, digoxin, and potassium sparing diuretics such as spironolactone
- Participating in other drug clinical trials EXCEPT for other COVID-19 treatment trials which will be allowed with the permission of the Corresponding PI or Co-PI and concurrence of the treating physician/hospitalist
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10x upper limit of normal (ULN) within 24 hours of baseline
- Absolute neutrophil count (ANC) < 1000/mL within 24 hours of baseline
- Platelet count < 50,000/mL within 24 hours of baseline.
- Patients with acute kidney injury (AKI) or chronic kidney disease (CKD) including individuals on hemodialysis may be enrolled based on the investigator's clinical judgement.
- Any serious medical condition/ abnormality or other issues that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or suggests that the study is not in the patient's best interest
- In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Treatment of COVID-19 in Hospitalized Patients
This study will enroll 40 inpatients hospitalized for COVID-19 at Queens' Medical Center. Participants will be randomized 1:1 to Telmisartan (80 mg) vs placebo to be administered orally once daily x 21 days.
Read the detailed description
The study is intended to assess, in a pilot study, the effect of telmisartan in mitigating the severity of COVID-19 related disease in hospitalized patients. Data on clinical course and lab values will be passively abstracted from Queen's standard of care evaluations on COVID-19 in-patients. Participants will be monitored closely as an outpatient if/when discharged prior to day 21. The only study-specific procedure will be a blood draw of ten (10) cc to be collected for research purposes at entry and at day 4 and day 21 of study for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of organ function/coagulation, inflammation, leukocyte chemotaxis, tissue remodeling/fibrosis and immune exhaustion.
- Conditions
- Covid19
- Being tested
- Telmisartan Oral Product, 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 Oral ProductDrug
Also called Micardis
Angiotensin Receptor Blocker (ARB) FDA approved for use in hypertension and for cardiovascular risk reduction
PlaceboDrug
Gelatin capsules filled with an inactive ingredient
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan (80 mg) | Active comparator | Telmisartan 80 mg (given as two 40 mg encapsulated tablets) given orally each day x 21 days Receives: Drug: Telmisartan Oral Product |
| Placebo | Placebo comparator | Two placebo capsules given orally each day x 21 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospitalization
Number of days of patient's hospitalization
Measured: Over the 21 day period of study
Secondary outcomes (5)
Duration of supplemental oxygen
Median number of days patients required supplemental oxygen in each arm
Measured: over the 21 days of study
Duration of mechanical ventilation
Median number of days patients required mechanical ventilation in each arm
Measured: over the 21 days of study
Number of deaths
Total number of deaths during the study period in each arm
Measured: over the 21 days of study
Number of grade 3 and greater adverse events
Total number of Grade 3 and greater adverse events that occurred in each arm
Measured: over the 21 days of study
Clinical severity of disease
Clinical severity of disease as assessed by WHO Clinical Status ordinal scale (scores range from minimum value of 1 (not hospitalized, no limitations on activities) to maximum value of 7 (death); higher is worse outcome.
Measured: On day 4 and 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.
- First posted20 Jan 2021
- Study start1 Sep 2021
- Primary completion26 Apr 2022
- Study completion26 Apr 2022
Why it stopped: Poor recruitment due to decrease in COVID-19 rates locally
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Model description
- Patients will be randomized 1:1 to Telmisartan (80 mg) vs placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's Medical Center
- Responsible party
- Sponsor
- Investigators
- Cecilia M Shikuma, Principal investigator, University of Hawaii at Manoa John A Burns School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715763
- Sponsor's protocol ID
- H053
- Acronym
- INTEL
- Status last verified
- Jun 2022
- First submitted
- 14 Jan 2021
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2022. 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 Treatment of COVID-19 in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04715763
- Acronym / sponsor ID
- INTEL / H053
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment due to decrease in COVID-19 rates locally
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of HawaiiUniversity, hospital or other
- Collaborators
- Queen's Medical Center
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 20 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll 40 inpatients hospitalized for COVID-19 at Queens' Medical Center. Participants will be randomized 1:1 to Telmisartan (80 mg) vs placebo to be administered orally once daily x 21 days.
Detailed description
The study is intended to assess, in a pilot study, the effect of telmisartan in mitigating the severity of COVID-19 related disease in hospitalized patients. Data on clinical course and lab values will be passively abstracted from Queen's standard of care evaluations on COVID-19 in-patients. Participants will be monitored closely as an outpatient if/when discharged prior to day 21. The only study-specific procedure will be a blood draw of ten (10) cc to be collected for research purposes at entry and at day 4 and day 21 of study for the evaluation of the renin-angiotensin system (RAS) system and for various blood biomarkers of organ function/coagulation, inflammation, leukocyte chemotaxis, tissue remodeling/fibrosis and immune exhaustion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to Telmisartan (80 mg) vs placebo
| Arm | Type | Receives |
|---|---|---|
| Telmisartan (80 mg) | Active comparator | Drug: Telmisartan Oral ProductTelmisartan 80 mg (given as two 40 mg encapsulated tablets) given orally each day x 21 days |
| Placebo | Placebo comparator | Drug: PlaceboTwo placebo capsules given orally each day x 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide written informed consent prior to initiation of any study procedures.
- Within 72 hours of initial hospitalization for acute COVID-19 disease management
- Male or non-pregnant female adult ≥18 years of age at time of enrolment.
- Able to easily swallow pills
Key exclusion criteria (15 listed)
- Systolic blood pressure less than 100 mmHg
- Self-reported history of decompensated liver failure
- Pregnancy or breast feeding
- Allergy to the study medication
- Current use of ARB, ACE inhibitors, or angiotensin receptor/neprilysin inhibitors (ARNIs). Blood pressure medications in other classes will be permitted as long as the systolic BP is >100 mmHg
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 Oral ProductAlso: MicardisAngiotensin Receptor Blocker (ARB) FDA approved for use in hypertension and for cardiovascular risk reduction | Drug | Telmisartan (80 mg) |
| PlaceboGelatin capsules filled with an inactive ingredient | Drug | Placebo |
Primary outcome
Duration of hospitalization
Time frame: Over the 21 day period of study
Number of days of patient's hospitalization
5 secondary outcomes
Duration of supplemental oxygen
Time frame: over the 21 days of study
Duration of mechanical ventilation
Time frame: over the 21 days of study
Number of deaths
Time frame: over the 21 days of study
Number of grade 3 and greater adverse events
Time frame: over the 21 days of study
Clinical severity of disease
Time frame: On day 4 and day 21 of study
Results and safety
The study was stopped early (reason given: Poor recruitment due to decrease in COVID-19 rates locally). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Individual participant dataSharing planned: No
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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 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 Oral Product in people with Covid19, 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 4 inclusion and 15 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 1 Jul 2022. 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?
The study was stopped early (reason given: Poor recruitment due to decrease in COVID-19 rates locally). Results are not available in the source record.
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?
Duration of hospitalization (time frame: Over the 21 day period of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2022.