Covid19 Clinical Trial
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
Verified date | February 2022 |
Source | Sorrento Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2021 |
Est. primary completion date | September 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Synergy Healthcare LLC | Bradenton | Florida |
United States | Collaborative NeuroScience Research, LLC | Garden Grove | California |
United States | Med-Care Research | Miami | Florida |
United States | ETNA Medical Center | Tamarac | Florida |
Lead Sponsor | Collaborator |
---|---|
Sorrento Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Randomization to Day 29 | |
Secondary | 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 | Randomization to Day 8, 15, 29, 43, 70 | |
Secondary | 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 | Randomization to Day 43 and Day 70 | |
Secondary | 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 | Randomization to Day 15, 29, 43 | |
Secondary | Time to resolution of fever | For subjects who have a fever at randomization, time to resolution of the fever | Randomization through study completion at Day 70 |
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