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

Phase 2

Withdrawn

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

• Registration Number: NCT04734860
• Lead Sponsor: Sorrento Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-02
• Study Start: 2021-04
• Primary Completion: 2021-09
• 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• Status: WITHDRAWN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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 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

Trial Locations

Locations (4)

Synergy Healthcare LLC; 🇺🇸 Bradenton, Florida, United States

Med-Care Research; 🇺🇸 Miami, Florida, United States

Collaborative NeuroScience Research, LLC; 🇺🇸 Garden Grove, California, United States

ETNA Medical Center; 🇺🇸 Tamarac, Florida, United States