Clinical trial NCT05135624: SP16 as a Therapeutic for COVID-19 Induced ARDS
Official title: SP16 as a Therapeutic for SARS-CoV-2 Induced ARDS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: SARS CoV 2 Infection
Pneumonia
Keywords: Pneumonia due to SARS-CoV-2
Lead sponsor: Serpin Pharma, LLC
Sponsor class: OTHER
Collaborators: name: University of Virginia
First posted: 2021-11-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Safety and tolerability of SP16 in subjects with pneumonia due to SARS-CoV-2
timeFrame: Day 1 to 14
measure: Change in inflammatory cytokines
timeFrame: Day 3, Day 6, and Day 14
measure: Change in acute phase reactants
timeFrame: Day 3, Day 6, and Day 14
Secondary outcomes:
measure: Proportion of subjects requiring ventilation
timeFrame: Day 14
measure: Improvement from baseline in SpO2
timeFrame: Days 3 and 14
measure: Cumulative days on ventilator
timeFrame: Day 1 to 14
measure: Duration of hospitalization
timeFrame: Day 1 to 14
measure: Time to clinical improvement
timeFrame: Day 1 to 14
measure: Proportion of subjects experiencing TTCI
timeFrame: Day 1 to 14
measure: Subjects time to death
timeFrame: Day 1 to 14
measure: Change from baseline in Horowitz index
timeFrame: Days 6 and 14
measure: Subject's cumulative days in ICU
timeFrame: Day 1 to 14
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: UVA Health Center
state: Virginia
Study officials:
References: