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.
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)
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.
Henry Ford Health Systems
Detroit, Michigan, United States