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

Phase 2

Terminated

• Conditions: Covid19
• Interventions: Biological: COVI-DROPS; Drug: Placebo

• Registration Number: NCT04900428
• Lead Sponsor: Sorrento Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-21
• Study First Posted: 2021-05-25
• Study Start: 2021-07-16
• Primary Completion: 2022-03-22
• Study Completion: 2022-05-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 179

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVI-DROPS	COVI-DROPS	10 mg or 20 mg of COVI-DROPS administered intranasally
Placebo	Placebo	1 mL administered intranasally

Primary Outcome Measures

Name	Time	Method
Viral load change from baseline to D8	Baseline to Day 8	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

Name	Time	Method
Change in patient-reported COVID-19 symptoms	Baseline to Day 8 and Day 29	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)
Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29	Baseline through Day 29	Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29
Worst WHO Clinical Progression Scale score up to D8 and from D9 to D29	Baseline through Day 29	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	Baseline to 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
The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29	Baseline through Day 29	The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations through D29
Change in WHO Clinical Progression Scale score	Baseline to Day 8 and Day 29	Change in WHO Clinical Progression Scale score at D8 and D29 (score of 0-10, with lower score meaning better outcome)

Trial Locations

Locations (1)

University Hospitals of Coventry and Warwickshire Hospital Trust; 🇬🇧 Coventry, United Kingdom