Covid19
Conditions
Keywords
covid-19
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.
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
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events by type, frequency, severity, and causality (safety) | Randomization through study completion at Day 70 | Safety as assessed by incidence of adverse events by type, frequency, severity, and causality |
| Changes in viral shedding from Baseline to Day 15 | Randomization to Day 15 | Changes in viral shedding from Baseline to Day 15 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in viral shedding from Baseline to Day 8, 29, 43, and 70 | Randomization to Day 8, 29, 43, 70 | Changes in viral shedding from Baseline to Day 8, 29, 43, and 70 |
| Time to viral RNA negativity | Randomization through study completion at Day 70 | Time to viral RNA negativity using nasopharyngeal reverse transcription PCR |
| Time to resolution of symptoms | Randomization through study completion at Day 70 | Time to resolution of symptoms as assessed by the COVID-19 PRO instrument |
Outcome results
None listed