NCT05135624

SP16 as a Therapeutic for COVID-19 Induced ARDS

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Serpin Pharma, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

SARS-CoV-2 infection is associated with excessive inflammation and cytokine storm that can result in lung damage and potentially severe disease. SP16 is an anti-inflammatory and homeostatic drug that rebalances innate immune responses potentially resulting in mitigation of inflammation and lung damage without immunosuppressive effects. SP16's mechanism of action is through targeting LRP1, a receptor that regulates a variety of physiological processes that contribute to inflammation and tissue injury, particularly in the lung. The main objective of this study is to determine the safety and tolerability, and effects on inflammation of SP16 administered subcutaneously at a dose of 6 mg (0.1 mg/kg) or 12 mg (0.2 mg/kg). SP16 has previously been well tolerated in both healthy individuals and heart attack patients at a dose of 0.2 mg/kg. The study will also evaluate improvements in clinical parameters such as patients requiring ventilation, improvement in blood oxygen levels (as defined by both SpO2 \> 95% and respiratory rate ≤ 20/minute) and duration of hospitalization or time spent in the Intensive Care Unit (ICU).

Conditions

• SARS CoV 2 Infection
• Pneumonia

Interventions

Type	Name	Description
DRUG	SP16 (6mg)	SP16 will be administered as 2 concurrent, separate 2 mL s.c injections of 3mg/mL SP16
OTHER	Placebo	Placebo will be administered as 2 concurrent, separate 2 mL s.c. injections of sterile water
DRUG	SP16 (12 mg)	SP16 will be administered as a single 2 mL s.c. injection of 3 mg/mL SP16 and 1 concurrent separate 2 mL s.c. injection of sterile water

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2021-11-26
• Last updated: 2024-05-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study