R-3750 in Patients With Late-Stage Acute Respiratory Distress Syndrome (ARDS)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRise Therapeutics LLC

About this trial

The goal of this clinical trial is to learn if R-3750 is safe in \[in patients with late-stage, non-resolving Acute Respiratory Distress Syndrome (ARDS) . The main question\[s\] it aims to answer are:

1. the favorable safety profile 2. clinical improvement that includes reduced ventilator dependence and improved lung function.

Participants will be given oral capsules daily and/or enteral nasogastric or orogastric (NG/OG tube) if necessary.

Eligibility criteria

Qualifiers

Age ≥18 years at the time of consent.

Hypoxemia defined as PaO2/FiO2 ≤300 mmHg, or SpO2/FiO2 ≤315 if SpO2 is ≤97%;

Bilateral pulmonary infiltrates/opacities on chest imaging consistent with pulmonary edema or fibroproliferative lung injury and not fully explained by pleural effusions, lobar collapse, or atelectasis;

Requirement for positive pressure respiratory support, including invasive mechanical ventilation via endotracheal tube;

Disqualifiers

Age <18 years.

More than 28 days since onset of ARDS at the time of enrollment.

ARDS that is clearly resolving rapidly, in the judgment of the investigator, such that enrollment in a 28-day rescue-therapy study is not clinically appropriate.

Pregnancy or breastfeeding.

Trial design

Treatments tested in this trial

  • R-3750

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators