SP16 as a Therapeutic for COVID-19 Induced ARDS

NCT05135624 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: IRBHSR#210341
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS CoV 2 Infection; Pneumonia

Keywords

Pneumonia due to SARS-CoV-2

Outcome Measures

Primary Outcomes (3)

• Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2

  Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2 based on number of adverse events (AEs)

  Day 1 to 14

• Change in inflammatory cytokines

  Subjects' change from baseline in plasma concentrations of inflammatory cytokines (IL-1β, TNF-α, IL-6, and IL-8)

  Day 3, Day 6, and Day 14

• Change in acute phase reactants

  Subjects' change from baseline of acute phase reactants (CRP, α-2 macroglobulin, fibrinogen, and D-dimer)

  Day 3, Day 6, and Day 14

Secondary Outcomes (9)

• Proportion of subjects requiring ventilation

  Day 14

• Improvement from baseline in SpO2

  Days 3 and 14

• Cumulative days on ventilator

  Day 1 to 14

• Duration of hospitalization

  Day 1 to 14

• Time to clinical improvement

  Day 1 to 14

Study Arms (3)

Cohort dose 1 of SP16

EXPERIMENTAL

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

Drug: SP16 (6mg)

Cohort dose 2 of SP16

EXPERIMENTAL

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

Drug: SP16 (12 mg)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

SP16 (6mg) DRUG

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

Cohort dose 1 of SP16

Placebo OTHER

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

Placebo

SP16 (12 mg) 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

Cohort dose 2 of SP16

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Serpin Pharma, LLC: lead
• University of Virginia: collaborator

Study Sites (1)

UVA Health Center

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

COVID-19; Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort 1 - 7 subjects will be randomized to receive SP16 6 mg or placebo in a 7:3 ratio. Cohort 2 - 7 subject will be randomized to receive SP16 12 mg or placebo in a 7:3 ratio.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 26, 2021
• Study Start: December 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)