Pilot Clinical Trial of the Safety and Efficacy of Telmisartan for the Mitigation of Pulmonary and Cardiac Complications in COVID-19 Patients
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Telmisartan 40mg; Placebo
Intervention description: Angiotensin Receptor Blocker (ARB); Placebo once daily
Intervention MeSH terms: Telmisartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Placebo controlled trial
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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