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NCT04360551 · ClinicalTrials.gov registry record · Phase 2

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, sponsored by University of Hawaii.

Terminated
Registry status
Phase 2
Development phase
24
Enrollment target

NCT04360551: Clinical Trial Phase 2 study, sponsored by University of Hawaii.

NCT04360551 is a Phase 2 study that was terminated before completion, run by University of Hawaii. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04360551, a Phase 2 study, was terminated before completion, sponsored by University of Hawaii.

TERMINATED
Registry status
Phase 2
Development phase
24 participants
Enrollment target

Study Summary

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.

Primary Outcome

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 hos

Interventions

  • DRUG Placebo
  • DRUG Telmisartan 40mg

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-07-01
Est. Completion 2022-04-26
Phase Phase 2
University of Hawaii

77 total trials

Why NCT04360551 stopped before completion

NCT04360551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04360551 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04360551 about?

NCT04360551 is a clinical study titled "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, ...

What is the current status of trial NCT04360551?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2020-07-01. Estimated completion is 2022-04-26.

What interventions are being tested in trial NCT04360551?

The interventions under investigation include: Placebo (DRUG), Telmisartan 40mg (DRUG).

Who is sponsoring clinical trial NCT04360551?

This trial is sponsored by University of Hawaii, which has 77 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04360551's enrollment target sits among peer trials

24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04360551, the US trial registry maintained by the National Library of Medicine. NCT04360551 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.