Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2021-11-30

Brief Summary

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Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.

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Detailed Description

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Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 days after dosing.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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COVI-AMG

40 mg, 100 mg, or 200 mg of COVI-AMG will be administered

Group Type EXPERIMENTAL

COVI-AMG

Intervention Type BIOLOGICAL

COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)

Placebo

Placebo will be administered

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Diluent solution

Interventions

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COVI-AMG

COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)

Intervention Type BIOLOGICAL

Placebo

Diluent solution

Intervention Type DRUG

Other Intervention Names

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STI-2020

Eligibility Criteria

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Inclusion Criteria

* Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization
* No medical or psychiatric conditions that could put the subject at risk
* Willing to follow contraception guidelines

Exclusion Criteria

* Clinical signs of COVID-19 indicative of impending hospitalization
* Documented infection in addition to COVID-19 that requires systemic treatment
* Medical condition that could adversely impact safety, in the Investigator's opinion
* Is or planning to be pregnant or lactating
* Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
* Has received or will receive during study participation a vaccine for COVID-19
* Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No