Covid19 Clinical Trial
Official title:
A Randomized, Blinded-controlled Study to Evaluate the Safety and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Hospitalized Adult Patients With COVID-19
NCT number | NCT04771351 |
Other study ID # | AMG-COV-202 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2021 |
Est. completion date | October 2021 |
Verified date | August 2022 |
Source | Sorrento Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a placebo-controlled study to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2021 |
Est. primary completion date | August 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 - Progressive disease suggestive of ongoing COVID-19 infection - Requires hospitalization for acute medical care - Provides written informed consent - Willing to follow contraception guidelines during study Exclusion Criteria: - Requires high-flow oxygen supplementation - Current or imminent respiratory failure - Has rapidly progressing symptoms that in the investigator's opinion are likely to progress to needing high-flow oxygen or to respiratory failure within 24 to 48 hours - Any condition which, in the investigator's opinion, participation would not be in the subject's best interest or could prevent, limit, or confound the protocol-specified assessments - Has participated, or is participating in, a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) - Pregnant or lactating and breast feeding, or planning on either during the study - Unable to comply with planned study procedures and be available for all follow-up visits |
Country | Name | City | State |
---|---|---|---|
United States | Teradan Clinical Trials | Brandon | Florida |
Lead Sponsor | Collaborator |
---|---|
Sorrento Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of subjects who are alive and free of respiratory failure at Day 29 | Proportion of subjects who are alive and free of respiratory failure at Day 29 | Baseline through Day 29 | |
Secondary | Viral load reduction | Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test | Baseline to Day 4, 15, and 29 | |
Secondary | Time to sustained clinical improvement | Time to sustained clinical improvement defined as achieving a score of =2 on the Ordinal Scale for Clinical Improvement (OSCI) for a continuous period of 48h and maintained to Day 29 | Baseline through Day 29 | |
Secondary | Proportion of subjects with clinical improvement | Proportion of subjects with clinical improvement defined as =2 on the OSCI at Day 15 and Day 29 | Baseline to Day 15 and 29 | |
Secondary | All-cause mortality at Day 29 | All-cause mortality at Day 29 | Baseline through Day 29 |
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