SP16 as a Therapeutic for SARS-CoV-2 Induced ARDS

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, placebo-controlled, Phase 1b study evaluates the safety and tolerability, and effects on cytokine and acute phase reactants of SP16, an anti-inflammatory drug, in patients with pneumonia due to SARS-CoV-2 infection. The study will enroll up to 20 patients and each eligible patient will be randomized to receive either one of two doses of SP16 (6 mg or 12 mg) or placebo by subcutaneous injection.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Serpin Pharma, LLC
• Collaborator: University of Virginia

Criteria

Inclusion Criteria:

To be considered eligible to participate in this study, the subject must meet all of the Inclusion criteria listed below:

• Hospitalized patients age ≥ 18 with diagnosis of SARS-CoV-2-infection based on positive

• PCR test result and can provide informed consent

• Diagnosed with pneumonia due to SARS-CoV-2

• Respiratory rate ≥ 25/minute and SpO2 ≤ 93%

• Review of Chest radiograph, chest computed tomography (CT) scan, or chest ultrasound consistent with bilateral infiltrates.

• Horowitz index (partial pressure of oxygen/fraction of inspired oxygen [PaO2/FiO2]) ≤ 300. If a subject does not have an arterial line in place, a SpO2/FiO2 ≤ 315 may be used.

Exclusion Criteria:

To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:

• Age < 18

• Pregnant or lactating women

• History of heart failure

• Clinically significant cardiac dysrhythmia, as determined by investigator

• History renal impairment

• Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 2000 mm3, aspartate aminotransferase