COVID-19 Inpatient Trials at the Frankel Cardiovascular Center

REPLACE COVID Trial

PI: J. Brian Byrd, M.D., M.S.

The Randomized Elimination or ProLongation of Angiotensin Converting Enzyme inhibitors and angiotensin receptor blockers in Coronavirus Disease 2019

https://clinicaltrials.gov/ct2/show/NCT04338009

The purpose of this study is to help answer whether ACE inhibitors (ACEI) or Angiotensin Receptor Blockers (ARBs), improve or worsen the risk of bad outcomes from COVID-19. ACEI and ARBs may impact how COVID-19 affects the body, but it is unknown if these medications help or hurt the virus. These medications may enhance binding of the virus to cells in the body, but they may also enhance the protective response of the body to the virus. Since we don’t know whether these can be beneficial or harmful, our goal is to look at the effect of temporarily stopping these medications while someone is hospitalized for COVID-19. Other than the possible changes to ACEI or ARB medications, patients will receive usual care for COVID-19 from the treating team. No other aspects of COVID-19 treatment are impacted by participation research study.

Inclusion Criteria:

  • Age 18 years or older (2)
  • Hospitalization with a suspected diagnosis of COVID-19, based on:        
    • A compatible clinical presentation with a positive laboratory test for SARS-CoV-2, or
    • Considered by the primary team to be a Person Under Investigation due to undergo testing for COVID-19 in addition to compatible pulmonary infiltrates on chest x-ray (bilateral, intersticial or ground glass opacities).
  • Use of ACEI or ARB as an outpatient prior to hospital admission.

Mesenchymal Stem Cell Trial

PI: Jonathan Golob, M.D. & CO-I Francis Pagani, M.D.

MSCs in COVID-19 ARDS

https://umhealthresearch.org/#studies/HUM00180086

https://clinicaltrials.gov/ct2/show/NCT04371393                                    

The purpose of this trial is to determine whether MSCs (mesenchymal stromal cells) are effective and safe in helping patients with moderate to severe ARDS due to COVID-19 infection. The MSCs used in this study are called remestemcel-L, and these human stem cells are derived from the bone marrow of healthy volunteers and cultured (grown) in a laboratory. This treatment is experimental, meaning that it has not been approved by the Food and Drug Administration (FDA) as a treatment for ARDS. The treatment is being developed by Mesoblast for the treatment of multiple diseases including ARDS due to COVID-19 Infection. Patients are still eligible for this trial if they are receiving remdesivir outside of a clinical trial.

Inclusion Criteria:

  • 18 years or older
  • Patient requiring mechanical ventilator support with moderate to severe ARDS

Exclusion Criteria:

  • Patients who have intubated for more than 72 hours
  • Patients currently receiving ECMO or HFOVaccep

DICER Trial

PI: Yogendra Kanthi, M.D. & CO-I Jason Knight, M.D.

Dipyridamole to Arrest Progression of Mild/moderate CoV-19 infection DICER

https://UMHealthResearch.org/#studies/HUM00179783

https://clinicaltrials.gov/ct2/show/NCT04391179

The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole (an FDA-approved drug) can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19. This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted to University of Michigan. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization.

Inclusion Criteria:

  • 18 years or older
  • Confirmed coronavirus infection, ≤ 72 hours of hospital admission or of COVID-19 confirmation
  • Currently hospitalized or anticipated hospitalization requiring supplemental oxygen ≤ 6 LPM by nasal cannula.

Exclusion Criteria:

  • Unlikely to survive for greater than 48 from screening
  • Currently on invasive mechanical ventilation

Contact Us

For direct questions about transferring patients, referring providers may contact M-LINE at 800-962-3555.

For non-urgent questions about the trials on this page, contact CVCVolunteer@med.umich.edu.