Back to resultsSP16 as a Therapeutic for COVID-19 Induced ARDS
Primary Purpose
SARS CoV 2 Infection, Pneumonia
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SP16 (6mg)
Placebo
SP16 (12 mg)
Sponsored by
About this trial
This is an interventional treatment trial for SARS CoV 2 Infection focused on measuring Pneumonia due to SARS-CoV-2
Eligibility 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
Sites / Locations
- UVA Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Cohort dose 1 of SP16
Cohort dose 2 of SP16
Placebo
Arm Description
Patients in cohort 1 (low dose SP16) will receive a single dose of SP16 (0.1 mg/kg or 6 mg) by subcutaneous injection
Patients in cohort 2 (high dose SP16) will receive a single dose of SP16 (0.2 mg/kg or 12 mg) by subcutaneous injection
Patients in placebo arm will receive sterile water by subcutaneous injection.
Outcomes
Primary Outcome Measures
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)
Change in inflammatory cytokines
Subjects' change from baseline in plasma concentrations of inflammatory cytokines (IL-1β, TNF-α, IL-6, and IL-8)
Change in acute phase reactants
Subjects' change from baseline of acute phase reactants (CRP, α-2 macroglobulin, fibrinogen, and D-dimer)
Secondary Outcome Measures
Proportion of subjects requiring ventilation
The proportion of subjects in each dose group who required intubation and noninvasive ventilation by Day 14
Improvement from baseline in SpO2
The proportion of subjects in each dose group who exhibited improvement from baseline in SpO2 levels, as defined by both SpO2 > 95% and respiratory rate ≤ 20/minute, at Days 3 and 14
Cumulative days on ventilator
Cumulative days on ventilator for each subject who required mechanical ventilation at any time during Day 1 to Day 14 period
Duration of hospitalization
Subjects' duration of hospitalization over the Day1 to Day 14 period
Time to clinical improvement
Subjects' time to clinical improvement (TTCI), which is defined as a National Early Warning Score 1 (NEWS2) of < 2 to be maintained for 24 h (during Days 1 to 14)
Proportion of subjects experiencing TTCI
The proportions of subjects in each cohort who experienced TTCI, which is defined as NEWS2 of < 2 to be maintained for 24 h
Subjects time to death
Subjects time to death or censoring over the period from Day 1 to Day 14 (subjects who withdraw prior to Day 14 will be censored on the day of withdrawal; subjects alive on Day 14 will be censored on Day 14)
Change from baseline in Horowitz index
Subjects' change from baseline on Days 6 and 14 in Horowitz index or in SpO2/FiO2
Subject's cumulative days in ICU
Subjects' cumulative number of days spent in the Intensive Care Unit (ICU) over Days 1 to 14
Full Information
NCT ID
NCT05135624
First Posted
November 9, 2021
Last Updated
December 10, 2021
Sponsor
Serpin Pharma, LLC
Collaborators
University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT05135624
Brief Title
SP16 as a Therapeutic for COVID-19 Induced ARDS
Official Title
SP16 as a Therapeutic for SARS-CoV-2 Induced ARDS
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Serpin Pharma, LLC
Collaborators
University of Virginia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS CoV 2 Infection, Pneumonia
Keywords
Pneumonia due to SARS-CoV-2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort dose 1 of SP16
Arm Type
Experimental
Arm Description
Patients in cohort 1 (low dose SP16) will receive a single dose of SP16 (0.1 mg/kg or 6 mg) by subcutaneous injection
Arm Title
Cohort dose 2 of SP16
Arm Type
Experimental
Arm Description
Patients in cohort 2 (high dose SP16) will receive a single dose of SP16 (0.2 mg/kg or 12 mg) by subcutaneous injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients in placebo arm will receive sterile water by subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
SP16 (6mg)
Intervention Description
SP16 will be administered as 2 concurrent, separate 2 mL s.c injections of 3mg/mL SP16
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered as 2 concurrent, separate 2 mL s.c. injections of sterile water
Intervention Type
Drug
Intervention Name(s)
SP16 (12 mg)
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2
Description
Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2 based on number of adverse events (AEs)
Time Frame
Day 1 to 14
Title
Change in inflammatory cytokines
Description
Subjects' change from baseline in plasma concentrations of inflammatory cytokines (IL-1β, TNF-α, IL-6, and IL-8)
Time Frame
Day 3, Day 6, and Day 14
Title
Change in acute phase reactants
Description
Subjects' change from baseline of acute phase reactants (CRP, α-2 macroglobulin, fibrinogen, and D-dimer)
Time Frame
Day 3, Day 6, and Day 14
Secondary Outcome Measure Information:
Title
Proportion of subjects requiring ventilation
Description
The proportion of subjects in each dose group who required intubation and noninvasive ventilation by Day 14
Time Frame
Day 14
Title
Improvement from baseline in SpO2
Description
The proportion of subjects in each dose group who exhibited improvement from baseline in SpO2 levels, as defined by both SpO2 > 95% and respiratory rate ≤ 20/minute, at Days 3 and 14
Time Frame
Days 3 and 14
Title
Cumulative days on ventilator
Description
Cumulative days on ventilator for each subject who required mechanical ventilation at any time during Day 1 to Day 14 period
Time Frame
Day 1 to 14
Title
Duration of hospitalization
Description
Subjects' duration of hospitalization over the Day1 to Day 14 period
Time Frame
Day 1 to 14
Title
Time to clinical improvement
Description
Subjects' time to clinical improvement (TTCI), which is defined as a National Early Warning Score 1 (NEWS2) of < 2 to be maintained for 24 h (during Days 1 to 14)
Time Frame
Day 1 to 14
Title
Proportion of subjects experiencing TTCI
Description
The proportions of subjects in each cohort who experienced TTCI, which is defined as NEWS2 of < 2 to be maintained for 24 h
Time Frame
Day 1 to 14
Title
Subjects time to death
Description
Subjects time to death or censoring over the period from Day 1 to Day 14 (subjects who withdraw prior to Day 14 will be censored on the day of withdrawal; subjects alive on Day 14 will be censored on Day 14)
Time Frame
Day 1 to 14
Title
Change from baseline in Horowitz index
Description
Subjects' change from baseline on Days 6 and 14 in Horowitz index or in SpO2/FiO2
Time Frame
Days 6 and 14
Title
Subject's cumulative days in ICU
Description
Subjects' cumulative number of days spent in the Intensive Care Unit (ICU) over Days 1 to 14
Time Frame
Day 1 to 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roselove Asare
Phone
4342436074
Email
rnn3b@virginia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Halle Raisigel
Phone
5712281708
Email
halle@serpinpharma.com
Facility Information:
Facility Name
UVA Health Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roselove Asare
Phone
434-243-6074
Email
rnn3b@virginia.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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SP16 as a Therapeutic for COVID-19 Induced ARDS
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