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

NCT05074394 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-02-03

No results posted yet for this study

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

Interventions

BIOLOGICAL

COVI-DROPS

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

DRUG

Placebo

Diluent solution

Sponsors & Collaborators

  • Sorrento Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Mike Royal, MD · Sorrento Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-11-30
Completion
2023-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074394 on ClinicalTrials.gov