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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04900428
• Other study ID #: DRP-COV-201UK
• Status: Terminated
• Phase: Phase 2
• Start date: July 16, 2021
• Est. completion date: May 6, 2022

Study information

• Verified date: January 2023
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 179
• Est. completion date: May 6, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Drug:
• Placebo
Diluent solution

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Coventry and Warwickshire Hospital Trust	Coventry

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Baseline through Day 29
Secondary	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	Baseline through Day 29
Secondary	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)	Baseline to Day 8 and Day 29
Secondary	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)	Baseline through Day 29
Secondary	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	Baseline to Day 29
Secondary	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)	Baseline to Day 8 and Day 29