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

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 controlle…