SP16 as a Therapeutic for COVID-19 Induced ARDS
SARS CoV 2 Infection, Pneumonia
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
Experimental
Experimental
Placebo Comparator
Cohort dose 1 of SP16
Cohort dose 2 of SP16
Placebo
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.