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

NCT04738175 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: AMG-COV-201-BR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Covid19

Keywords

covid-19

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events by type, frequency, severity, and causality (safety)

  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

  Changes in viral shedding from Baseline to Day 15

  Randomization to Day 15

Secondary Outcomes (3)

• 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

  Randomization through study completion at Day 70

• Time to resolution of symptoms

  Randomization through study completion at Day 70

Study Arms (2)

COVI-AMG

EXPERIMENTAL

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

Biological: COVI-AMG

Placebo

PLACEBO COMPARATOR

Placebo will be administered

Drug: Placebo

Interventions

COVI-AMG BIOLOGICAL

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

Also known as: STI-2020

COVI-AMG

Placebo DRUG

Diluent solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

MeSH Terms

Conditions

COVID-19

Interventions

STI-2020

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 4, 2021
• Study Start: April 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: February 25, 2022

Record last verified: 2022-02