Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK)

Sorrento Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Covid19

Treatments: Drug: Placebo; Biological: COVI-DROPS

Study type: Interventional

Funder types: Industry

Identifiers

NCT04900428

DRP-COV-201UK

Details and patient eligibility

About

This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.

Full description

Subjects will be randomized 2:2:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg or matched placebo in a double-blind manner. Investigational product (COVI-DROPS or matched placebo) will be administered once as two separate 0.5 mL instillations (0.5 mL up each nostril). Subjects will be followed to Day 60.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive for COVID-19 with any locally approved RT-PCR within 7 days of planned treatment.
• Either have no COVID-19 symptoms (asymptomatic) or mild illness/symptoms
• Must be willing and able to comply with all planned study procedures and be available for all in-person and telephonic study visits and follow-up as required per protocol
• Subject must have provided written informed consent
• Willing to follow contraception guidelines

Exclusion criteria

• Moderate or severe illness/symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours)
• Any medical condition that, in the Investigator's opinion, could adversely impact subject safety or key objectives of the study, including any intranasal pathology, or clinically significant laboratory abnormalities, or active clinical disease process
• Documented acute infection other thand COVID-19
• Pregnant or lactating women who are breast feeding or planning to during the study
• Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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179 participants in 2 patient groups, including a placebo group

COVI-DROPS

Experimental group

Description:

10 mg or 20 mg of COVI-DROPS administered intranasally

Treatment:

Biological: COVI-DROPS

Placebo

Placebo Comparator group

Description:

1 mL administered intranasally

Treatment:

Drug: Placebo