Covid19
Conditions
Keywords
covid-19
Brief summary
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.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled study designed to investigate the safety and efficacy of a single injection of COVI-AMG in inpatient adults with COVID-19. Subjects will receive 100 mg of COVI-AMG, 200 mg of COVI-AMG, or placebo via slow IV push. Subjects will be followed for approximately 70 days post dosing.
Interventions
BIOLOGICALCOVI-AMG
COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
DRUGPlacebo
Diluent solution
Sponsors
Sorrento Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who are alive and free of respiratory failure at Day 29 | Baseline through Day 29 | Proportion of subjects who are alive and free of respiratory failure at Day 29 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral load reduction | Baseline to Day 4, 15, and 29 | Log-10 viral load reduction from baseline to Day 4, Day 15, and Day 29 by nasopharyngeal RT-PCR test |
| Time to sustained clinical improvement | Baseline through Day 29 | 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 |
| Proportion of subjects with clinical improvement | Baseline to Day 15 and 29 | Proportion of subjects with clinical improvement defined as ≤2 on the OSCI at Day 15 and Day 29 |
| All-cause mortality at Day 29 | Baseline through Day 29 | All-cause mortality at Day 29 |
Countries
United States
Outcome results
None listed