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

Covid19 Clinical Trial

Official title:

A Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intranasal STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04906694
• Other study ID #: DRP-COV-201US
• Status: Completed
• Phase: Phase 2
• Start date: November 16, 2021
• Est. completion date: January 13, 2022

Study information

• Verified date: January 2022
• 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 1:1:1:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg, COVI-DROPS 40 mg, or placebo in a double-blind manner. Investigational product (COVI-DROPS or placebo) will be administered once on Study Day 1. Subjects will be followed to Day 60.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: January 13, 2022
• Est. primary completion date: January 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment

• Either have no COVID-19 symptoms (asymptomatic) or mild symptoms

• Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol

• Subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity

• Willing to follow contraception guidelines

Exclusion Criteria:

• In the investigator's opinion, has moderate or severe 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 safety or key objectives of the study, particularly any intranasal pathology or disease process.

• Has a documented infection other than COVID-19

• Pregnant or lactating women who are breast feeding or planning on either during the study

• Has participated or is participating in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (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

• Has a high risk of progressing to severe COVID-19 per CDC's risk stratification (See:

https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-c onditions.html)

• Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection.

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 States	WR-ClinSearch	Chattanooga	Tennessee
United States	Future Innovative Treatments, LLC	Colorado Springs	Colorado
United States	Remington Davis	Columbus	Ohio
United States	Revival Research Institute	Dearborn	Michigan
United States	Advanced Medical Trials	Georgetown	Texas
United States	Precision Comprehensive Clinical Research Solutions	Grapevine	Texas
United States	Cyn3rgy Research	Gresham	Oregon
United States	Centex Studies Inc. Houston	Houston	Texas
United States	Clinical Neuroscience dba CNS Healthcare	Jacksonville	Florida
United States	Infectious Diseases Associates of Central Virginia	Lynchburg	Virginia
United States	Med-Care Research	Miami	Florida
United States	Quality Clinical Research	Omaha	Nebraska
United States	Clinical Neuroscience Solutions Healthcare	Orlando	Florida
United States	Randomize Now	Peachtree City	Georgia
United States	LinQ	Pearland	Texas
United States	Epic Research	Red Oak	Texas
United States	Precision Research Center	Tampa	Florida
United States	Clinical Site Partners, Inc	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who have COVID-19-related visit or hospitalization	Proportion of subjects who have COVID-19-related urgent medically-attended visit, emergency department assessment or hospitalization through D29 = COVID-19-related visits or hospitalization (CRVHD29)	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	Viral load change from baseline to D8	Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL)	Baseline to Day 8
Secondary	Change in WHO Clinical Progression Scale score	Change in WHO Clinical Progression score at D8 and D29 (score of 0-10, with lower score meaning better outcome)	Baseline to Day 8 and Day 29
Secondary	Viral load change from baseline to D29	Viral load change from baseline to D29, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL)	Baseline to Day 29