SP16 as a Therapeutic for COVID-19 Induced ARDS

NCT ID: NCT05135624

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort dose 1 of SP16

Patients in cohort 1 (low dose SP16) will receive a single dose of SP16 (0.1 mg/kg or 6 mg) by subcutaneous injection

Group Type: EXPERIMENTAL

SP16 (6mg)

Intervention Type: DRUG

SP16 will be administered as 2 concurrent, separate 2 mL s.c injections of 3mg/mL SP16

Cohort dose 2 of SP16

Patients in cohort 2 (high dose SP16) will receive a single dose of SP16 (0.2 mg/kg or 12 mg) by subcutaneous injection

Group Type: EXPERIMENTAL

SP16 (12 mg)

Intervention Type: DRUG

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

Placebo

Patients in placebo arm will receive sterile water by subcutaneous injection.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo will be administered as 2 concurrent, separate 2 mL s.c. injections of sterile water

Interventions

SP16 (6mg)

SP16 will be administered as 2 concurrent, separate 2 mL s.c injections of 3mg/mL SP16

Intervention Type: DRUG

Placebo

Placebo will be administered as 2 concurrent, separate 2 mL s.c. injections of sterile water

Intervention Type: OTHER

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

Serpin Pharma, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UVA Health Center

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

IRBHSR#210341

Identifier Type: -

Identifier Source: org_study_id