Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19 (STAMP)

Invivyd

Status and phase: Terminated; Phase 3; Phase 2

Conditions: COVID-19

Treatments: Drug: ADG20; Drug: Normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT04805671

ADG20-TRMT-001

Details and patient eligibility

About

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.

Enrollment: 399 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

NOTE: Other protocol defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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399 participants in 2 patient groups, including a placebo group

ADG20 IM

Experimental group

Description:

Participants will be dosed on Day 1 with ADG20 IM

Treatment:

Drug: ADG20

Placebo IM

Placebo Comparator group

Description:

Participants will be dosed on Day 1 with placebo IM

Treatment:

Drug: Normal saline