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

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
COVI-DROPS
Placebo
Sponsored by
Sorrento Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring covid-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospitals of Coventry and Warwickshire Hospital Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COVI-DROPS

Placebo

Arm Description

10 mg or 20 mg of COVI-DROPS administered intranasally

1 mL administered intranasally

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29
The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Change in WHO Clinical Progression Scale score
Change in WHO Clinical Progression Scale score at D8 and D29 (score of 0-10, with lower score meaning better outcome)
Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29
Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29 (score of 0-10, with lower score meaning better outcome)
Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs
Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs
Change in patient-reported COVID-19 symptoms
Change in patient-reported COVID-19 symptoms as assessed using the Patient Reported Outcome Instrument for Capture of COVID-19-Related Symptoms (score of 0-50, with lower score meaning better outcome)

Full Information

First Posted
May 20, 2021
Last Updated
January 26, 2023
Sponsor
Sorrento Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04900428
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated at interim analysis due to drops not working on new variants
Study Start Date
July 16, 2021 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
May 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorrento Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
covid-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVI-DROPS
Arm Type
Experimental
Arm Description
10 mg or 20 mg of COVI-DROPS administered intranasally
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1 mL administered intranasally
Intervention Type
Biological
Intervention Name(s)
COVI-DROPS
Other Intervention Name(s)
STI-2099
Intervention Description
COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Diluent solution
Primary Outcome Measure Information:
Title
Viral load change from baseline to D8
Description
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
Time Frame
Baseline to Day 8
Secondary Outcome Measure Information:
Title
The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29
Description
The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29
Time Frame
Baseline through Day 29
Title
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Description
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Time Frame
Baseline through Day 29
Title
Change in WHO Clinical Progression Scale score
Description
Change in WHO Clinical Progression Scale score at D8 and D29 (score of 0-10, with lower score meaning better outcome)
Time Frame
Baseline to Day 8 and Day 29
Title
Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29
Description
Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29 (score of 0-10, with lower score meaning better outcome)
Time Frame
Baseline through Day 29
Title
Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs
Description
Viral load change from baseline to D29 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) from nasopharyngeal swabs
Time Frame
Baseline to Day 29
Title
Change in patient-reported COVID-19 symptoms
Description
Change in patient-reported COVID-19 symptoms as assessed using the Patient Reported Outcome Instrument for Capture of COVID-19-Related Symptoms (score of 0-50, with lower score meaning better outcome)
Time Frame
Baseline to Day 8 and Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Royal, MD
Organizational Affiliation
Sorrento Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University Hospitals of Coventry and Warwickshire Hospital Trust
City
Coventry
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34473343
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.
Results Reference
derived

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

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