Clinical trial NCT04734860: Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms
Official title: A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Covid19
Keywords: covid-19
Lead sponsor: Sorrento Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-02
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects who have remained out of the hospital or emergency room through Day 29
timeFrame: Randomization to Day 29
Secondary outcomes:
measure: Viral load reduction from baseline to Day 8, 15, 29, 43, and 70
timeFrame: Randomization to Day 8, 15, 29, 43, 70
measure: Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70
timeFrame: Randomization to Day 43 and Day 70
measure: Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score
timeFrame: Randomization to Day 15, 29, 43
measure: Time to resolution of fever
timeFrame: Randomization through study completion at Day 70
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Collaborative NeuroScience Research, LLC
state: California
city: Bradenton
country: United States
facility: Synergy Healthcare LLC
state: Florida
city: Miami
country: United States
facility: Med-Care Research
state: Florida
city: Tamarac
country: United States
facility: ETNA Medical Center
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.