Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
Primary Purpose
Covid19
Status
Withdrawn
Phase
Phase 1
Locations
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:
- Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization
- No medical or psychiatric conditions that could put the subject at risk
- Willing to follow contraception guidelines
Exclusion Criteria:
- Clinical signs of COVID-19 indicative of impending hospitalization
- Documented infection in addition to COVID-19 that requires systemic treatment
- Medical condition that could adversely impact safety, in the Investigator's opinion
- Is or planning to be pregnant or lactating
- 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
- Has received or will receive during study participation a vaccine for COVID-19
- Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
COVI-AMG
Placebo
Arm Description
40 mg, 100 mg, or 200 mg of COVI-AMG will be administered
Placebo will be administered
Outcomes
Primary Outcome Measures
Incidence of adverse events by type, frequency, severity, and causality (safety)
Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
Changes in viral shedding from Baseline to Day 15
Changes in viral shedding from Baseline to Day 15
Secondary Outcome Measures
Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
Time to viral RNA negativity
Time to viral RNA negativity using nasopharyngeal reverse transcription PCR
Time to resolution of symptoms
Time to resolution of symptoms as assessed by the COVID-19 PRO instrument
Full Information
NCT ID
NCT04738175
First Posted
February 2, 2021
Last Updated
February 9, 2022
Sponsor
Sorrento Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04738175
Brief Title
Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
Official Title
A Randomized, Controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
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
November 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
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.
Detailed Description
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push. Subjects will be followed for 70 days after 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 1, 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
40 mg, 100 mg, or 200 mg of COVI-AMG will be administered
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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
Incidence of adverse events by type, frequency, severity, and causality (safety)
Description
Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
Time Frame
Randomization through study completion at Day 70
Title
Changes in viral shedding from Baseline to Day 15
Description
Changes in viral shedding from Baseline to Day 15
Time Frame
Randomization to Day 15
Secondary Outcome Measure Information:
Title
Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
Description
Changes in viral shedding from Baseline to Day 8, 29, 43, and 70
Time Frame
Randomization to Day 8, 29, 43, 70
Title
Time to viral RNA negativity
Description
Time to viral RNA negativity using nasopharyngeal reverse transcription PCR
Time Frame
Randomization through study completion at Day 70
Title
Time to resolution of symptoms
Description
Time to resolution of symptoms as assessed by the COVID-19 PRO instrument
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:
Outpatient with recent COVID-19 diagnosis with mild or moderate symptoms lasting less than 7 days prior to Screening and not requiring imminent hospitalization
No medical or psychiatric conditions that could put the subject at risk
Willing to follow contraception guidelines
Exclusion Criteria:
Clinical signs of COVID-19 indicative of impending hospitalization
Documented infection in addition to COVID-19 that requires systemic treatment
Medical condition that could adversely impact safety, in the Investigator's opinion
Is or planning to be pregnant or lactating
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
Has received or will receive during study participation a vaccine for COVID-19
Has participated in clinical trial protocols in the last 12 months, unless the Investigator believes that there may be a direct benefit to the subject
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Royal, MD
Organizational Affiliation
Sorrento Therapeutics
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) to Treat COVID-19
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