Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms

A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04734860

Enrollment

Registered

2021-02-02

Start date

2021-04-30

Completion date

2021-11-30

Last updated

2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

covid-19

Brief summary

This study investigates the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms.

Detailed description

This is a multi-center, randomized, double-blind study designed to investigate the safety, pharmacokinetic (PK) profile and efficacy of a single injection of COVI-AMG in outpatient adults with mild COVID-19 symptoms. Subjects will be followed for approximately 70 days post dosing.

Interventions

BIOLOGICALCOVI-AMG

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

DRUGPlacebo

Diluent solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Positive for COVID-19 by an approved antigen test * Mild symptoms consistent with a COVID-19 viral infection * Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol * Willing to follow contraception guidelines

Exclusion criteria

* Evidence of moderate COVID-19 per FDA severity categorization * Pregnant or lactating and breast feeding or planning on either during the study * Has a documented infection other than COVID-19 * Has received a COVID-19 vaccine * 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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of subjects who have remained out of the hospital or emergency room through Day 29	Randomization to Day 29	Proportion of subjects who have remained out of the hospital or emergency room through Day 29

Secondary

Measure	Time frame	Description
Viral load reduction from baseline to Day 8, 15, 29, 43, and 70	Randomization to Day 8, 15, 29, 43, 70	Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 as assessed by nasopharyngeal RT-PCR test
Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70	Randomization to Day 43 and Day 70	Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70
Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score	Randomization to Day 15, 29, 43	Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score from baseline at Day 15, 29, and 43
Time to resolution of fever	Randomization through study completion at Day 70	For subjects who have a fever at randomization, time to resolution of the fever

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026