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COVI-DROPS (STI-2099) in Outpatient Adults With COVID-19
NCT04900428Phase 2
Key facts
- Status
- Terminated
- Start
- Jul 2021
- Primary completion
- Mar 2022
- Countries
- 1
- Sponsor
- Sorrento Therapeutics
- Modality
- Monoclonal Antibodies
- Drugs
- STI-2099
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 2, randomised, double-blind trial of STI-2099 in coronavirus disease 2019 (COVID-19) (3 arms), sponsored by Sorrento Therapeutics. Primary endpoint: Viral load change from baseline to Day 8. Started Jul 2021; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
COVI-DROPS 10 mg
Single intranasal dose of 10 mg COVI-DROPS
COVI-DROPS 20 mg
Single intranasal dose of 20 mg COVI-DROPS
Placebo
Single intranasal dose of matched placebo
03
Who it enrols
Adult outpatients with confirmed positive COVID-19 RT-PCR within 7 days, who are asymptomatic or have mild symptoms. Patients with moderate/severe symptoms, imminent hospitalization, or recent participation in other COVID-19 treatment trials are excluded.
04
Endpoints
Primary
Viral load change from baseline to Day 8
Secondary
The number of COVID-19-related urgent medically attended visits, emergency department assessments or hospitalizations
Proportion of subjects alive and free of hospitalization > 24h duration for acute COVID-19 illness management
Change in WHO Clinical Progression Scale score
Worst WHO Clinical Progression Scale score
Viral load change from baseline to Day 29
Change in patient-reported COVID-19 symptoms
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