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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04738175
• Other study ID #: AMG-COV-201-BR
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: April 2021
• Est. completion date: November 2021

Study information

• Verified date: February 2022
• Source: Sorrento Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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

Drug:
• Placebo
Diluent solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sorrento Therapeutics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in viral shedding from Baseline to Day 15	Changes in viral shedding from Baseline to Day 15	Randomization to Day 15
Secondary	Changes in viral shedding from Baseline to Day 8, 29, 43, and 70	Changes in viral shedding from Baseline to Day 8, 29, 43, and 70	Randomization to Day 8, 29, 43, 70
Secondary	Time to viral RNA negativity	Time to viral RNA negativity using nasopharyngeal reverse transcription PCR	Randomization through study completion at Day 70
Secondary	Time to resolution of symptoms	Time to resolution of symptoms as assessed by the COVID-19 PRO instrument	Randomization through study completion at Day 70