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

Sponsor
Sorrento Therapeutics, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05074394
Collaborator
(none)
1,800
Enrollment
2
Arms
14
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: COVI-DROPS
  • Drug: Placebo
Phase 2

Detailed Description

Subjects will be randomized 2:1 to receive a single dose of COVI-DROPS (40 mg) or placebo in a double-blind manner. Investigational product (COVI-DROP or placebo) will be administered once on Study Day 1 and followed to Day 29. Subjects will be stratified based upon prior history of infection or vaccination versus the group who is unvaccinated and not previously infected with COVID-19.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal STI-2099 (COVI-DROPS™) as Treatment for COVID-19 Infection in Outpatient Adults
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: COVI-DROPS

40 mg of COVI-DROPS administered intranasally

Biological: COVI-DROPS
COVI-DROPS is a fully human monoclonal antibody that is a neutralizing antibody to SARS-CoV-2
Other Names:
  • STI-2099
  • Placebo Comparator: Placebo

    2 mL placebo administered intranasally

    Drug: Placebo
    Diluent solution

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects who have a COVID-19-related visit or hospitalization [Baseline through Day 29]

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

    Secondary Outcome Measures

    1. Viral load change from baseline to Day 15 (D15) [Baseline through Day 15]

      Viral load change from baseline to D15 based on nasal quantitative reverse transcription polymerase chain reaction (RT-PCR) COVID-19 viral titers (Log-10 copies/mL). Includes viral load change for subjects in the unvaccinated/no prior infection group as well as the vaccinated/prior infection group

    2. Proportion of subjects who have a COVID-19-related visit or hospitalization based on stratification groups [Baseline to Day 29]

      For each of the unvaccinated/no prior infection group or the vaccinated/prior infection group, proportion of subjects with COVID-19-related urgent medically attended visits, emergency department assessments, hospitalizations ≥ 24h or all-cause death through D29

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • 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

    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)

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sorrento Therapeutics, Inc.

    Investigators

    • Study Director: Mike Royal, MD, Sorrento Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sorrento Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT05074394
    Other Study ID Numbers:
    • DRP-COV-206US
    First Posted:
    Oct 12, 2021
    Last Update Posted:
    Oct 12, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sorrento Therapeutics, Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2021