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

Phase 2

Withdrawn

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

• Registration Number: NCT04771351
• Lead Sponsor: Sorrento Therapeutics, Inc.

Brief Summary

This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.

Detailed Description

This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post dosing.

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-25
• Study Start: 2021-04
• Primary Completion: 2021-08
• Study Completion: 2021-10
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-16

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

• Positive for COVID-19 by an approved antigen test
• Progressive disease suggestive of ongoing COVID-19 infection
• Requires hospitalization for acute medical care
• Provides written informed consent
• Willing to follow contraception guidelines during study

Exclusion Criteria

• Requires high-flow oxygen supplementation
• Current or imminent respiratory failure
• Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours
• Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments
• Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer)
• Pregnant or lactating and breast feeding, or planning on either during the study
• Unable to comply with planned study procedures and be available for all follow-up visits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who are alive and free of respiratory failure at Day 29	Baseline through Day 29	Proportion of subjects who are alive and free of respiratory failure at Day 29

Secondary Outcome Measures

Name	Time	Method
Time to sustained clinical improvement	Baseline through Day 29	Time to sustained clinical improvement defined as achieving a score of ≤2 on the Ordinal Scale for Clinical Improvement (OSCI) for a continuous period of 48h and maintained to Day 29
Viral load reduction	Baseline to Day 4, 15, and 29	Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test
Proportion of subjects with clinical improvement	Baseline to Day 15 and 29	Proportion of subjects with clinical improvement defined as ≤2 on the OSCI at Day 15 and Day 29
All-cause mortality at Day 29	Baseline through Day 29	All-cause mortality at Day 29

Trial Locations

Locations (1)

Teradan Clinical Trials; 🇺🇸 Brandon, Florida, United States