Relief Therapeutics Holding AG (RLFTF)

[mc67]

$RLFTF Phase IIb/III studies in Acute Respiratory Distress Syndrome induced by COVID-19:

Two phase IIb/III clinical studies to document Aviptadil efficacy in patients with severe or moderate COVID-19 induced ARDS are on-going. These trials are done in partnering with NeuroRx, a US based company
( http://neurorxpharma.com/).

Aviptadil for COVID-19 Associated Acute Respiratory Distress (COVID-AIV)

A multicenter, placebo-controlled, quadruple masking (Participant, Care Provider, Investigator, Outcomes Assessor), randomized interventional clinical trial.

Patients with COVID-19 induced Acute Respiratory Distress Syndrome who are admitted for intensive care including endotracheal intubation and mechanical ventilation will be treated with Aviptadil, plus maximal intensive care vs. placebo, plus maximal intensive care. Patients will be randomized to intravenous Aviptadil will receive escalating doses from 50 -150 pmol/kg/hr over 12 hours. This trial has been expanded to include patients receiving high flow oxygen and noninvasive ventilation (CPAP), in addition to those on ventilators. The primary endpoint will be mortality at 5 days with follow-up through 30 days.

Estimated Study Completion Date: September 2020

Further details on ClinicalTrials.gov, identifier: NCT04311697.



Aviptadil for the Treatment of Non-Acute Lung Injury in COVID-19 (AVINALI):

A multicenter, placebo-controlled, quadruple masking (Participant, Care Provider, Investigator, Outcomes Assessor), randomized interventional clinical trial.

Patients with COVID-19 induced non-Acute Lung Injury who have demonstrated reduction in blood oxygenation, dyspnea, and exercise intolerance but do not require endotracheal intubation and mechanical ventilation will be treated with Aviptadil plus Standard of Care vs. placebo, plus Standard of Care. Patients will be randomized to inhaled Aviptadil, 100 µg/inhalation, 3x daily vs. placebo 3x daily. The primary outcome will be progression to ARDS over 28 days. Estimated Study Completion Date: October 1, 2020

Further details on ClinicalTrials.gov, identifier NCT04360096

https://relieftherapeutics.com/clinical-trials-2/