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Clinical Trials/NCT04906694
NCT04906694CompletedPhase 2

A Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Intranasal STI-2099 (COVI-DROPS™) in Outpatient Adults With COVID-19

Sorrento Therapeutics, Inc.18 sites in 1 country97 target enrollmentStarted: November 16, 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
97
Locations
18
Primary Endpoint
Proportion of subjects who have COVID-19-related visit or hospitalization
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
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
  • •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.

Arms & Interventions

COVI-DROPS

Experimental

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

Intervention: COVI-DROPS (Biological)

Placebo

Placebo Comparator

2 mL administered intranasally

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (18)

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