Randomized Study to Evaluate Intranasal Dose of STI-2099 (COVI-DROPS™) in Outpatient Adults With Mild COVID-19 Infection

NCT05074394 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: DRP-COV-206US
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is prospective double-blind study in the United States is designed to investigate the efficacy and safety of a single dose of COVI-DROPS or matched placebo in outpatient adults with mild symptoms associated with COVID-19 and a recent positive COVID-19 test.

Conditions

COVID-19

Keywords

COVID19; COVID-19

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects who have a COVID-19-related visit or hospitalization

  Proportion of subjects with COVID-19-related urgent medically attended visits, emergency department assessments, hospitalizations ≥ 24h or all-cause death through Day 29 (D29)

  Baseline through Day 29

Secondary Outcomes (2)

• Viral load change from baseline to Day 15 (D15)

  Baseline through Day 15

• Proportion of subjects who have a COVID-19-related visit or hospitalization based on stratification groups

  Baseline to Day 29

Study Arms (2)

COVI-DROPS

EXPERIMENTAL

40 mg of COVI-DROPS administered intranasally

Biological: COVI-DROPS

Placebo

PLACEBO COMPARATOR

2 mL placebo administered intranasally

Drug: Placebo

Interventions

COVI-DROPS BIOLOGICAL

COVI-DROPS is a fully human monoclonal antibody that 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+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment
• Have mild illness/symptoms based upon NIH criteria. The NIH illness severity definition for "mild" states as follows: "Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging."
• Be in good health as judged by investigator using screening medical history and physical examination. Participants who are otherwise healthy with a stable chronic medical condition may enroll
• A prior COVID-19 infection in the past from which the subject fully recovered or a previously unknown asymptomatic infection is allowed, as is any previous COVID-19 vaccination
• 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 the 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)
• Currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to COVID-19 infection
• Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection
• Has an active documented infection other than COVID-19
• 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
• Pregnant or lactating women who are breast feeding or planning on either during the study
• Has received within the 30 days prior to screening or is planning on receiving an EUA-cleared monoclonal antibody (mAb) during the study
• Has participated or is participating in a clinical research study evaluating COVID-19 convalescent plasma, other non-EUA-cleared mAbs against COVID-19 or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

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: October 7, 2021
• First Posted: October 12, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: January 1, 2023
• Last Updated: February 3, 2022

Record last verified: 2022-01