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Completed

NCT Number: NCT04906694

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Future Innovative Treatments, LLC, Colorado Springs, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVI-DROPS

Biological

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

Other names: STI-2099

Placebo

Drug

Diluent solution

Primary outcomes

  1. Proportion of subjects who have COVID-19-related visit or hospitalization

    Time frame: 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 outcomes

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

    Time frame: Baseline through Day 29

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

  2. Viral load change from baseline to D8

    Time frame: Baseline to Day 8

    Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL)

  3. Change in WHO Clinical Progression Scale score

    Time frame: 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)

  4. Viral load change from baseline to D29

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Sorrento Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 28, 2021
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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