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SWIM816 booster for COVID-19
NCT05911087Phase 3
Key facts
- Status
- Unknown
- Start
- Jun 2023
- Primary completion
- Jul 2023
- Sponsor
- Stemirna Therapeutics
- Modality
- Prophylactic Vaccines, mRNA Therapeutics
- Drugs
- SWIM-816
- Conditions
- coronavirus disease 2019 (COVID-19)
01
Overview
Phase 3, randomised, double-blind trial of SWIM-816 in coronavirus disease 2019 (COVID-19), sponsored by Stemirna Therapeutics. Primary endpoints: Geometric Mean Titers of SARS-CoV-2 Omicron neutralizing antibody at 15 days, Geometric Mean Fold Rise of SARS-CoV-2 Omicron neutralizing antibody at 15 days and 5 more. Status: unknown.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Adults >=18 years previously vaccinated with 2-3 doses of COVID-19 vaccine (last dose 6-24 months prior). Healthy or stable pre-existing conditions.
04
Endpoints
Primary
Geometric Mean Titers of SARS-CoV-2 Omicron neutralizing antibody
Geometric Mean Fold Rise of SARS-CoV-2 Omicron neutralizing antibody
Percentage of participants with seroresponse
Geometric Mean Ratio of neutralizing antibody
Occurrence of local and systemic Adverse Events
Secondary
Geometric Mean Titers of SARS-CoV-2 Omicron neutralizing antibody (Long-term)
IgG Binding Antibody Profile
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