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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 69 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Study intervention, RLS-0071 or placebo, will be administered as an IV infusion over 30 minutes (± 10 minutes). The following dose groups are planned: Part A (Single-Ascending Dose): - Cohort 1: low dose (single infusion) vs. placebo - Cohort 2: high dose (single infusion) vs. placebo Part B (Multiple-Ascending Dose): - Cohort 3: low dose administered q8 hours (± 1 hour) vs. placebo for 3 days (9 doses) - Cohort 4: high dose administered q8 hours (± 1 hour) vs. placebo for 3 days (9 doses)
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Masking Description
This study is a double-blinded and randomized study. Pharmacy staff will mask infusion bags and lines to maintain the study blind.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1
  • Drug: RLS-0071 10 mg/kg
    Single dose IV infusion of 10 mg/kg RLS-0071
  • Drug: Placebo
    The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia [USP]).
Experimental
Cohort 2
  • 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]).
Placebo Comparator
Placebo Cohorts 1 and 2 		Placebo will be administered at the same volume and duration of IV infusion corresponding to the cohort dosing schedule.
  • Drug: Placebo
    The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia [USP]).
Experimental
Cohort 3
  • 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)
Experimental
Cohort 4
  • Drug: Placebo
    The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia [USP]).
  • 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)
Placebo Comparator
Placebo Cohorts 3 and 4 		Placebo will be administered at the same volume and duration of IV infusion corresponding to the cohort dosing schedule.
  • Drug: Placebo
    The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia [USP]).

Recruiting Locations

More Details

NCT ID
NCT04574869
Status
Withdrawn
Sponsor
ReAlta Life Sciences, Inc.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.