Jump to Header Jump to Main Content Jump to Footer

Inhaled RLF-100 for treatement of severe Covid-19 without respiratory failure

Richard Lee


A Study On:

  • Coronavirus Infection

Status:

  • Open

Eligibility

12 Years to 85 Years (Child, Adult, Older Adult)

Interested in joining this trial?

Official Title

Inhaled RLF-100 for treatement of severe Covid-19 without respiratory failure

Details

SARS-CoV-2 virus infection is known to cause Lung Injury that begins as dyspnea and exercise intolerance, but may rapidly progress to Critical COVID-19 with Respiratory Failure and the need for noninvasive or mechanical ventilation. Mortality rates as high as 80% have been reported among those who require mechanical ventilation, despite best available intensive care.

Patients with moderate and severe COVID-19 by FDA definition who have not developed respiratory failure be treated with nebulized RLF-100 (aviptadil, a synthetic version of Vasoactive Intestinal Polypeptide (VIP)) 100 μg 3x daily plus Standard of Care vs. placebo + Standard of Care using an FDA 501(k) cleared mesh nebulizer.

The primary outcome will be progression to in severity of COVID-19 (i.e. moderate progressing to to severe or critical OR severe progressing to critical) over 28 days. Secondary outcomes will include blood oxygenation as measured by pulse oximetry, dyspnea, exercise tolerance, and levels of TNFα IL-6 and other cytokines.


Eligibility

You can join if...

Inclusion Criteria:

  1. Moderate or Severe COVID-19 by FDA definition with no evidence of Respiratory Failure
    Capable of using mesh nebulizer to administer medication with assistance if needed

Exclusion Criteria:

  1. Evidence of Respiratory Failure
  2. Use or impending use of ventilation or high flow nasal oxygen 20L or greater
    4) Age <12 years; 5) Diastolic pressure < 65 mm Hg; 6) Irreversible underlying condition with projected fatal course; 7) Immunosuppressive treatment for transplant or other reasons; 8) Cancer, renal failure, congestive heart failure, neurological disorder 9) Recent myocardial infarction with Troponin >0.5

Get in touch with our study team