Clinical trial NCT04771351: Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adults With COVID-19
Official title: A Randomized, Blinded-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adult Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Covid19
Keywords: covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects who are alive and free of respiratory failure at Day 29
timeFrame: Baseline through Day 29
Secondary outcomes:
measure: Viral load reduction
timeFrame: Baseline to Day 4, 15, and 29
measure: Time to sustained clinical improvement
timeFrame: Baseline through Day 29
measure: Proportion of subjects with clinical improvement
timeFrame: Baseline to Day 15 and 29
measure: All-cause mortality at Day 29
timeFrame: Baseline through Day 29
Other outcomes:
Locations:
city: Brandon
country: United States
facility: Teradan Clinical Trials
state: Florida
Study officials:
affiliation: Sorrento Therapeutics
name: Mike Royal, MD
role: STUDY_DIRECTOR
References:
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.