SP16 as a Therapeutic for COVID-19 Induced ARDS
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- 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
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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 |
|
|
Experimental 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 |
|
|
Placebo Comparator Placebo |
Patients in placebo arm will receive sterile water by subcutaneous injection. |
|
Recruiting Locations
More Details
- NCT ID
- NCT05135624
- Status
- Terminated
- Sponsor
- Serpin Pharma, LLC
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).