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

NCT04900428 | Terminated Phase 2 FDA Drug

• 1 other identifier: DRP-COV-201UK
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

covid-19

Outcome Measures

Primary Outcomes (1)

• Viral load change from baseline to D8

  Viral load change from baseline to D8, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL) from nasopharyngeal swabs

  Baseline to Day 8

Secondary Outcomes (6)

• The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29

  Baseline through Day 29

• Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29

  Baseline through Day 29

• Change in WHO Clinical Progression Scale score

  Baseline to Day 8 and Day 29

• Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29

  Baseline through Day 29

• Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs

  Baseline to Day 29

Study Arms (2)

COVI-DROPS

EXPERIMENTAL

10 mg or 20 mg of COVI-DROPS administered intranasally

Biological: COVI-DROPS

Placebo

PLACEBO COMPARATOR

1 mL administered intranasally

Drug: Placebo

Interventions

COVI-DROPS BIOLOGICAL

COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2

Also known as: STI-2099

COVI-DROPS

Placebo DRUG

Diluent solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (1)

University Hospitals of Coventry and Warwickshire Hospital Trust

Coventry, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

STI-2020

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: July 16, 2021
• Primary Completion: March 22, 2022
• Study Completion: May 6, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Locations

GB (1)