Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19
This study is a randomized, double-blind, placebo-controlled study to evaluate the safety,
pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™), a COVID-19
targeting monoclonal antibody, in hospitalized patients with moderate COVID-19. Four dose
levels will be tested: 10 mg, 30 mg, 100 mg, and 200 mg.
Biological: COVI-GUARD
COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein
Other Name: STI-1499
Other: Standard of Care
Standard of Care as determined by the Investigator
Drug: Placebo
Diluent
Inclusion Criteria:
- Evidence of moderate COVID-19, diagnosed standard RT-PCR assay or equivalent testing
- Willing and able to comply with study procedures and follow-up visits
- Subject or family member/caregiver must have provided written informed consent which
includes signing the institutional review board approved consent form prior to
participating in any study related activity. However, if obtaining written informed
consent is not possible, other procedures as provided in the March 27th, 2020 FDA
Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,
Question 10, may be used.
Exclusion Criteria:
- Clinical signs indicative of severe COVID-19
- Rapidly progressive COVID-19 which is likely to progress to "severe" within 24 hours
- Documented infection other than COVID-19
- Any medical condition that, in the Investigator's opinion, could adversely impact
safety
- Pregnant or lactating women
- Has participated, or is participating, in a clinical research study evaluating
COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or
intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the
investigational product (whichever is longer) prior to the screening visit. Note:
Participants who have been prescribed hydroxychloroquine or chloroquine with or
without azithromycin or other approved products for the off-label treatment of
COVID-19 prior to study enrollment may be included and may continue to receive these
agents so long as the dose remains stable. Additionally, any approved or authorized
treatment (e.g., remdesivir, dexamethasone or treatments approved under an Emergency
Use Authorization) is allowed.
Temple University Lung Center
Philadelphia, Pennsylvania, 19140
Investigator: Gerard Criner, MD
Investigator: Gerard Criner, MD
Mike Royal, MD, Study Director
Sorrento Therapeutics