Clinical trial NCT04900428: Study to Evaluate a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19 (UK)
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Single Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Covid19
Keywords: covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-25
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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 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

Primary outcomes:
measure: Viral load change from baseline to D8
timeFrame: Baseline to Day 8
Secondary outcomes:
measure: The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29
timeFrame: Baseline through Day 29
measure: Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
timeFrame: Baseline through Day 29
measure: Change in WHO Clinical Progression Scale score
timeFrame: Baseline to Day 8 and Day 29
measure: Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29
timeFrame: Baseline through Day 29
measure: Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs
timeFrame: Baseline to Day 29
measure: Change in patient-reported COVID-19 symptoms
timeFrame: Baseline to Day 8 and Day 29
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals of Coventry and Warwickshire Hospital Trust
Study officials:
affiliation: Sorrento Therapeutics, Inc.
name: Mike Royal, MD
role: STUDY_DIRECTOR
References:
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.