Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients
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ClinicalTrials.gov Identifier: NCT04360551 |
Recruitment Status :
Recruiting
First Posted : April 24, 2020
Last Update Posted : August 3, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Telmisartan 40mg Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Masking Description: | Placebo controlled trial |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 1, 2020 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | June 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Telmisartan
Telmisartan 40 mg po daily x 21 days
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Drug: Telmisartan 40mg
Angiotensin Receptor Blocker (ARB) |
Placebo Comparator: Placebo
Placebo
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Drug: Placebo
Placebo once daily |
- Maximum clinical severity of disease [ Time Frame: Over the 21 day period of study ]Based on a modified World Health Organization (WHO) COVID-19 7-point ordinal scale
- Incidence of treatment emergent adverse events [ Time Frame: 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
- Renin angiotensin system peptides [ Time Frame: At each study time point (day 4, day 10, day 21) ]Angiotensin I (AngI), AngII, Ang1-9 and Ang1-7
- Plasma biomarkers [ Time Frame: At each study time point (day 4, day 10, day 21) ]plasma biomarkers of organ function/coagulation, inflammation, leukocyte chemotaxis, tissue remodeling/fibrosis and immune exhaustion by Luminex multiplexing assays such as TNF-alpha, IL-6, CK-MB, Troponin I, Fractalkine, MCP-1, PD-1, TIMP-1

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04360551
Contact: Cecilia M Shikuma, MD | 808 692-1328 | shikuma@hawaii.edu | |
Contact: Debra Ogata-Arakaki, RN | 808 692-1332 | ogataara@hawaii.edu |
United States, Hawaii | |
University of Hawaii - Manoa, John A Burns School of Medicine UH Clinics at Kakaako | Recruiting |
Honolulu, Hawaii, United States, 96813 | |
Contact: Cecilia Shikuma, MD 808-692-1328 shikuma@hawaii.edu | |
Contact: Debra Ogata-Arakaki, RN 808 692-1332 ogataara@hawaii.edu |
Principal Investigator: | Cecilia M Shikuma, MD | University of Hawaii at Manoa John A Burns School of Medicine |
Responsible Party: | University of Hawaii |
ClinicalTrials.gov Identifier: | NCT04360551 |
Other Study ID Numbers: |
H051 |
First Posted: | April 24, 2020 Key Record Dates |
Last Update Posted: | August 3, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Telmisartan Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |