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

NCT ID: NCT04574869

Last Updated: 2022-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2022-12-31

Brief 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

Acute Lung Injury; ALI; COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort 1

Group Type: EXPERIMENTAL

RLS-0071 10 mg/kg

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Cohort 2

Group Type: EXPERIMENTAL

RLS-0071 40 mg/kg

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Placebo Cohorts 1 and 2

Placebo will be administered at the same volume and duration of IV infusion corresponding to the cohort dosing schedule.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Cohort 3

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

RLS-0071 10 mg/kg

Intervention Type: DRUG

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

Cohort 4

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

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

RLS-0071 40 mg/kg

Intervention Type: DRUG

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

Placebo Cohorts 3 and 4

Placebo will be administered at the same volume and duration of IV infusion corresponding to the cohort dosing schedule.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

RLS-0071 10 mg/kg

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

Intervention Type: DRUG

RLS-0071 40 mg/kg

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

Intervention Type: DRUG

Placebo

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

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Confirmed COVID-19 based on positive SARS-CoV-2 viral RNA PCR or antigen test.
• Hypoxemia.
• Radiographic evidence of opacification consistent with viral-related pneumonia.
• Weight less than 150 kg.
• Provide written informed consent.

Exclusion Criteria

• Endotracheal intubation and mechanical ventilation.
• Noninvasive positive pressure ventilation without endotracheal intubation.
• Requires chronic oxygen therapy.
• Treatment with conventional synthetic disease-modifying antirheumatic drugs (DMARDs)/immunosuppressive agents for ≥ 4 weeks duration within 3 months prior to the Screening visit.
• Use of oral corticosteroids in a dose higher than prednisone 15 mg or equivalent per day for ≥ 4 weeks duration within 3 months prior to the Screening visit.
• Systemic autoimmune disease.
• Participation in any clinical research study evaluating an investigational product or therapy within 3 months prior to the Screening visit,
• Presence of any of the following abnormal laboratory values at Screening: absolute neutrophil count < 2,000/mm3, aspartate aminotransferase or alanine aminotransferase > 5 × upper limit of normal (ULN), platelets < 50,000/mm3.
• D-dimer > 2 × ULN at Screening, as evidence of potential disseminated intravascular coagulation (DIC).
• Has confounding medical conditions, including poorly controlled diabetes, uncontrolled New York Heart Association Class III congestive heart failure, clinically significant arrhythmias not controlled by medication, idiopathic pulmonary fibrosis, interstitial lung disease, or chronic obstructive pulmonary disease.
• Has bacterial sepsis currently or suspicion thereof.
• Has cancer currently and is receiving active treatment (including radiation therapy or chemotherapy) or malignancy within the last 5 years, with the exception of curable cancer (eg, basal or squamous cell skin cancer, cervical cancer in situ, nonmedullary thyroid carcinoma) that has been adequately treated (eg, excision).
• Prior history of myocardial infarction or angina, stroke or transient ischemic attack (TIA), pulmonary embolism or deep vein thrombosis.
• Is moribund and not expected to survive 48 hours following Screening or for whom no further aggressive treatment such as mechanical ventilation is planned.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ReAlta Life Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenji Cunnion, MD, MPH

Role: STUDY_CHAIR

ReAlta Life Sciences, Inc.

Linda Dell

Role: STUDY_DIRECTOR

ReAlta Life Sciences, Inc.

Locations

Henry Ford Health Systems

Detroit, Michigan, United States

Countries

United States

References

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Reference Type: DERIVED

PMID: 34473343 (View on PubMed)

Other Identifiers

RLS-0071-102

Identifier Type: -

Identifier Source: org_study_id