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A Study of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure

NCT04574869 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-02-04

No results posted yet for this study

Summary

The aim of this study will test the safety, tolerability, and efficacy of RLS-0071 for approximately 28 days in comparison to a placebo control in patients with acute lung injury due to COVID-19 pneumonia in early respiratory failure.

Patients will be randomized and double-blinded for two parts, a single-ascending dose (SAD) part and a multiple-ascending dose (MAD) part.

The name of the study drug involved in this study is: RLS-0071.

Conditions

Interventions

DRUG

RLS-0071 10 mg/kg

Single dose IV infusion of 10 mg/kg RLS-0071

DRUG

RLS-0071 40 mg/kg

Single dose IV infusion of 40 mg/kg RLS-0071

DRUG

Placebo

The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia \[USP\]).

DRUG

RLS-0071 10 mg/kg

Multiple dose IV infusion of 10 mg/kg RLS-0071 administered every 8 hours for approximately 3 days (9 consecutive doses)

DRUG

RLS-0071 40 mg/kg

Multiple dose IV infusion of 40 mg/kg RLS-0071 administered every 8 hours for approximately 3 days (9 consecutive doses)

Sponsors & Collaborators

  • ReAlta Life Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Kenji Cunnion, MD, MPH · ReAlta Life Sciences, Inc.

  • Linda Dell · ReAlta Life Sciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2022-09-30
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04574869 on ClinicalTrials.gov