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

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.

Purpose of Study

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.

Eligibility

Age:
18 +
Sex:
All

Key Inclusion / Exclusion Criteria

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

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

Conditions:

COVID-19

Status:

Active, not recruiting

Phase:

Phase 2

Study ID

NCT04900428

Read Detailed Summary

Start Date / End Date:

18/07/2021 -

Enrollment:

350

Full Details:

https://clinicaltrials.gov/ct2/show/NCT04900428

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1 Study Locations

United Kingdom

University Hospitals of Coventry and Warwickshire Hospital Trust
Coventry,
United Kingdom


Study Locations Map: