Covid19 Clinical Trial
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
Verified date | February 2022 |
Source | Sorrento Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Subjects will receive a single injection of 40, 100, or 200 mg COVI-AMG or placebo via IV push.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2021 |
Est. primary completion date | November 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sorrento Therapeutics, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Randomization through study completion at Day 70 | |
Primary | Changes in viral shedding from Baseline to Day 15 | Changes in viral shedding from Baseline to Day 15 | Randomization to Day 15 | |
Secondary | 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 | Randomization to Day 8, 29, 43, 70 | |
Secondary | Time to viral RNA negativity | Time to viral RNA negativity using nasopharyngeal reverse transcription PCR | Randomization through study completion at Day 70 | |
Secondary | Time to resolution of symptoms | Time to resolution of symptoms as assessed by the COVID-19 PRO instrument | Randomization through study completion at Day 70 |
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