A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants With Mild or Moderate COVID-19 (STAMP)

TerminadoFase 3ClinicalTrials.gov

ID: NCT04805671Tipo: INTERVENTIONALInicio: 26 de jul de 2021Fin estimado: 3 de nov de 2022

Traducción no disponible, mostrando original

Resumen

This placebo controlled study is intended to generate safety and efficacy data in order to provide a treatment option for COVID-19 in patients with a high risk of disease progression based on age or co-morbid medical conditions.

Elegibilidad

Edad mínima: 12 YearsSexo: ALL

Criterios de inclusión

Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization
Has had symptoms consistent with COVID-19 with onset 5 days before randomization
Has one or more COVID-19-related signs or symptoms on the day of randomization
Phase 2: Is an adult aged 18 years and above
Phase 3: Is an adult aged 18 years and above or is an adolescent aged 12 to 17 years (inclusive) and weighing ≥40 kg at the time of screening

Criterios de exclusión

Is currently hospitalized or in the opinion of the investigator is anticipated to require hospitalization within 48 hours of randomization.
Has severe COVID-19 or is on supplemental oxygen
Has a history of a positive SARS-CoV-2 antibody serology test
Has participated, within the last 30 days, in a clinical study involving an investigational intervention
Has received a SARS-CoV-2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID-19 any time prior to participation in the study

Intervenciones

drug

ADG20

Single dose of ADG20

drug

Normal saline

Single dose of normal saline

Ubicaciones

Adagio Investigative Site

Estomba, Buenos Aires, Argentina

Adagio Investigative Site

Munro, Buenos Aires, Argentina

Adagio Investigative Site

Río Cuarto, Córdoba Province, Argentina

Adagio Investigative Site

Rosario, Santa Fe Province, Argentina

Adagio Investigative Site

Rosario, Santa Fe Province, Argentina

Adagio Investigative Site

San Miguel de Tucumán, Tucumán Province, Argentina

Adagio Investigative Site

Mar del Plata, Argentina

Patrocinadores

PrincipalInvivyd, Inc.

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