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

NCT04906694 | Completed Phase 2 FDA Drug

• 1 other identifier: DRP-COV-201US
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 18

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.

Conditions

Covid19

Keywords

covid-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29

  Baseline through Day 29

• Viral load change from baseline to D8

  Baseline to Day 8

• Change in WHO Clinical Progression Scale score

  Baseline to Day 8 and Day 29

• Viral load change from baseline to D29

  Baseline to Day 29

Study Arms (2)

COVI-DROPS

EXPERIMENTAL

10, 20, or 40 mg of COVI-DROPS administered intranasally

Biological: COVI-DROPS

Placebo

PLACEBO COMPARATOR

2 mL administered intranasally

Drug: Placebo

Interventions

COVI-DROPS BIOLOGICAL

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

Also known as: STI-2099

COVI-DROPS

Placebo DRUG

Diluent solution

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

Study Sites (18)

Future Innovative Treatments, LLC

Colorado Springs, Colorado, 80907, United States

Location

Clinical Neuroscience dba CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

Med-Care Research

Miami, Florida, 33165, United States

Location

Clinical Neuroscience Solutions Healthcare

Orlando, Florida, 32801, United States

Location

Precision Research Center

Tampa, Florida, 33614, United States

Location

Clinical Site Partners, Inc

Winter Park, Florida, 32789, United States

Location

Randomize Now

Peachtree City, Georgia, 30269, United States

Location

Revival Research Institute

Dearborn, Michigan, 48126, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Remington Davis

Columbus, Ohio, 43215, United States

Location

Cyn3rgy Research

Gresham, Oregon, 97030, United States

Location

WR-ClinSearch

Chattanooga, Tennessee, 37421, United States

Location

Advanced Medical Trials

Georgetown, Texas, 78628, United States

Location

Precision Comprehensive Clinical Research Solutions

Grapevine, Texas, 76051, United States

Location

Centex Studies Inc. Houston

Houston, Texas, 77062, United States

Location

LinQ

Pearland, Texas, 77584, United States

Location

Epic Research

Red Oak, Texas, 75154, United States

Location

Infectious Diseases Associates of Central Virginia

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

STI-2020

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: May 28, 2021
• Study Start: November 16, 2021
• Primary Completion: January 13, 2022
• Study Completion: January 13, 2022
• Last Updated: February 3, 2022

Record last verified: 2022-01

Locations

US (18)