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

Phase 1

Withdrawn

• Conditions: Covid19
• Interventions: Biological: COVI-AMG; Drug: Placebo

• Registration Number: NCT04738175
• Lead Sponsor: Sorrento Therapeutics, Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-04
• Study Start: 2021-04
• Primary Completion: 2021-11
• Study Completion: 2021-11
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COVI-AMG	COVI-AMG	40 mg, 100 mg, or 200 mg of COVI-AMG will be administered
Placebo	Placebo	Placebo will be administered

Primary Outcome Measures

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

Secondary Outcome Measures

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