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

February 9, 2022 updated by: Sorrento Therapeutics, Inc.

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: COVI-AMG
40 mg, 100 mg, or 200 mg of COVI-AMG will be administered
Biological: COVI-AMG
COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
Other Names:
  • STI-2020
PLACEBO_COMPARATOR: Placebo
Placebo will be administered
Drug: Placebo
Diluent solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events by type, frequency, severity, and causality (safety)
Time Frame: Randomization through study completion at Day 70
Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
Randomization through study completion at Day 70
Changes in viral shedding from Baseline to Day 15
Time Frame: Randomization to Day 15
Changes in viral shedding from Baseline to Day 15
Randomization to Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
Time Frame: Randomization to Day 8, 29, 43, 70
Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
Randomization to Day 8, 29, 43, 70
Time to viral RNA negativity
Time Frame: Randomization through study completion at Day 70
Time to viral RNA negativity using nasopharyngeal reverse transcription PCR
Randomization through study completion at Day 70
Time to resolution of symptoms
Time Frame: Randomization through study completion at Day 70
Time to resolution of symptoms as assessed by the COVID-19 PRO instrument
Randomization through study completion at Day 70

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorrento Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

November 1, 2021

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 2, 2021

First Posted (ACTUAL)

February 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMG-COV-201-BR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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