Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms
Primary Purpose
Covid19
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
COVI-AMG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring covid-19
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
Sites / Locations
- Collaborative NeuroScience Research, LLC
- Synergy Healthcare LLC
- Med-Care Research
- ETNA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
COVI-AMG
Placebo
Arm Description
A single injection of 40 mg, 100 mg, or 200 mg of COVI-AMG will be administered
A single injection of placebo will be administered
Outcomes
Primary Outcome Measures
Proportion of subjects who have remained out of the hospital or emergency room through Day 29
Proportion of subjects who have remained out of the hospital or emergency room through Day 29
Secondary Outcome Measures
Viral load reduction from baseline to Day 8, 15, 29, 43, and 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 remained out of the hospital or emergency room through Day 43 and 70
Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70
Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score
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
For subjects who have a fever at randomization, time to resolution of the fever
Full Information
NCT ID
NCT04734860
First Posted
January 29, 2021
Last Updated
February 9, 2022
Sponsor
Sorrento Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04734860
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
A different study will be conducted.
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
November 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorrento Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
covid-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COVI-AMG
Arm Type
Experimental
Arm Description
A single injection of 40 mg, 100 mg, or 200 mg of COVI-AMG will be administered
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A single injection of placebo will be administered
Intervention Type
Biological
Intervention Name(s)
COVI-AMG
Other Intervention Name(s)
STI-2020
Intervention Description
COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Diluent solution
Primary Outcome Measure Information:
Title
Proportion of subjects who have remained out of the hospital or emergency room through Day 29
Description
Proportion of subjects who have remained out of the hospital or emergency room through Day 29
Time Frame
Randomization to Day 29
Secondary Outcome Measure Information:
Title
Viral load reduction from baseline to Day 8, 15, 29, 43, and 70
Description
Viral load reduction from baseline to Day 8, 15, 29, 43, and 70 as assessed by nasopharyngeal RT-PCR test
Time Frame
Randomization to Day 8, 15, 29, 43, 70
Title
Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70
Description
Proportion of subjects who have remained out of the hospital or emergency room through Day 43 and 70
Time Frame
Randomization to Day 43 and Day 70
Title
Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score
Description
Proportion of subjects who have 50%, 70%, and 90% reduction in PRO instrument score from baseline at Day 15, 29, and 43
Time Frame
Randomization to Day 15, 29, 43
Title
Time to resolution of fever
Description
For subjects who have a fever at randomization, time to resolution of the fever
Time Frame
Randomization through study completion at Day 70
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Royal, MD
Organizational Affiliation
Sorrento Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative NeuroScience Research, LLC
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Synergy Healthcare LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Med-Care Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
ETNA Medical Center
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34473343
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.
Results Reference
derived
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Study to Evaluate a Single Dose of STI-2020 (COVI-AMG™) in Adults With Mild COVID-19 Symptoms
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