Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 Infection

• Status: Not yet recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is prospective double-blind study in the United States is designed to investigate the efficacy and safety of a single dose of COVI-DROPS or matched placebo in outpatient adults with mild symptoms associated with COVID-19 and a recent positive COVID-19 test.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sorrento Therapeutics, Inc.

Criteria

Inclusion Criteria:

• Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment

• Have mild illness/symptoms based upon NIH criteria. The NIH illness severity definition for "mild" states as follows: "Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging."

• Be in good health as judged by investigator using screening medical history and physical examination. Participants who are otherwise healthy with a stable chronic medical condition may enroll

• A prior COVID-19 infection in the past from which the subject fully recovered or a previously unknown asymptomatic infection is allowed, as is any previous COVID-19 vaccination

• Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol

• Subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity

• Willing to follow contraception guidelines

Exclusion Criteria:

• In the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours)

• Currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to COVID-19 infection

• Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection

• Has an active documented infection other than COVID-19

• Any medical condition that, in the Investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process

• Pregnant or lactating women who are breast feeding or planning on either during the study

• Has received within the 30 days prior to screening or is planning on receiving an EUA-cleared monoclonal antibody (mAb) during the study

• Has participated or is participating in a clinical research study evaluating COVID-19 convalescent plasma, other non-EUA-cleared mAbs against COVID-19 or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit