A Dose Escalation Study of NanO2 in Patients With Mild Respiratory Distress
ConditionMild Respiratory Distress
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuvOx LLC
About this trial
EXTEND is a dose escalation study of NanO2™ in patients with mild respiratory distress who are at risk for mechanical ventilation. The study will establish dosing guidelines for a Phase 2 study.
Eligibility criteria
Qualifiers
Requiring supplemental oxygen but ≤ 6L oxygen by nasal cannula to maintain an oxygen saturation >92% or PaO2 >60mmHg
Admitted to a hospital with symptoms of mild RD
Signed informed consent obtained from the subject or subject's legally authorized representative
Agrees to not participate in another clinical trial for the treatment of mild RD through Day 28
Disqualifiers
Presence of extracorporeal membrane oxygenation
Unstable hypertension
History of significantly impaired renal function defined as an eGFR ≤ 30mL/min/1.73m2 (MDRD equation or similar) or impaired hepatic function defined as the presence of decompensated cirrhosis (acute deterioration in liver function characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage)
Presence of pulmonary embolism at baseline
Trial design
Treatments tested in this trial
- dodecafluoropentane (0.025 mL/kg)
- dodecafluoropentane (0.032 mL/kg)
- dodecafluoropentane (0.050 mL/kg)
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov