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

Phase 2

Completed

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

• Registration Number: NCT04906694
• 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 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.

Study Timeline

• Study First Submitted: 2021-05-26
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-28
• Study Start: 2021-11-16
• Status Verified: 2022-01
• Primary Completion: 2022-01-13
• Study Completion: 2022-01-13
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	2 mL administered intranasally
COVI-DROPS	COVI-DROPS	10, 20, or 40 mg of COVI-DROPS administered intranasally

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who have COVID-19-related visit or hospitalization	Baseline through Day 29	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)

Secondary Outcome Measures

Name	Time	Method
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
Viral load change from baseline to D8	Baseline to Day 8	Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL)
Change in WHO Clinical Progression Scale score	Baseline to Day 8 and Day 29	Change in WHO Clinical Progression score at D8 and D29 (score of 0-10, with lower score meaning better outcome)
Viral load change from baseline to D29	Baseline to Day 29	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)

Trial Locations

Locations (18)

Centex Studies Inc. Houston; 🇺🇸 Houston, Texas, United States

Clinical Site Partners, Inc; 🇺🇸 Winter Park, Florida, United States

Remington Davis; 🇺🇸 Columbus, Ohio, United States

WR-ClinSearch; 🇺🇸 Chattanooga, Tennessee, United States

Randomize Now; 🇺🇸 Peachtree City, Georgia, United States

LinQ; 🇺🇸 Pearland, Texas, United States

Med-Care Research; 🇺🇸 Miami, Florida, United States

Precision Research Center; 🇺🇸 Tampa, Florida, United States

Advanced Medical Trials; 🇺🇸 Georgetown, Texas, United States

Clinical Neuroscience Solutions Healthcare; 🇺🇸 Orlando, Florida, United States

Revival Research Institute; 🇺🇸 Dearborn, Michigan, United States

Quality Clinical Research; 🇺🇸 Omaha, Nebraska, United States

Infectious Diseases Associates of Central Virginia; 🇺🇸 Lynchburg, Virginia, United States

Cyn3rgy Research; 🇺🇸 Gresham, Oregon, United States

Precision Comprehensive Clinical Research Solutions; 🇺🇸 Grapevine, Texas, United States

Epic Research; 🇺🇸 Red Oak, Texas, United States

Future Innovative Treatments, LLC; 🇺🇸 Colorado Springs, Colorado, United States

Clinical Neuroscience dba CNS Healthcare; 🇺🇸 Jacksonville, Florida, United States