Overview

Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19

Status:
Withdrawn
Trial end date:
2021-01-01
Target enrollment:
0
Participant gender:
All
Summary
Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARDâ„¢) in hospitalized patients with moderate COVID-19
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sorrento Therapeutics, Inc.
Criteria
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.