Covid19
Conditions
Keywords
covid-19
Brief summary
This is a double-blind study designed to investigate the efficacy, safety and PK of a single dose of COVI-DROPS or matched placebo in outpatient adults who have tested positive for COVID-19 and are either asymptomatic or have mild symptoms.
Detailed description
Subjects will be randomized 1:1:1:1 to receive a single dose of COVI-DROPS 10 mg, COVI-DROPS 20 mg, COVI-DROPS 40 mg, or placebo in a double-blind manner. Investigational product (COVI-DROPS or placebo) will be administered once on Study Day 1. Subjects will be followed to Day 60.
Interventions
BIOLOGICALCOVI-DROPS
COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
DRUGPlacebo
Diluent solution
Sponsors
Sorrento Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment * Either have no COVID-19 symptoms (asymptomatic) or mild symptoms * Must be willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by this protocol * Subject must have provided written informed consent which includes signing the institutional review board or independent ethics committee approved consent form prior to participating in any study related activity * Willing to follow contraception guidelines
Exclusion criteria
* In the investigator's opinion, has moderate or severe symptoms or rapidly progressive symptoms which are likely to progress such that a hospitalization is imminent (within 24-48 hours) * Any medical condition that, in the Investigator's opinion, could adversely impact safety or key objectives of the study, particularly any intranasal pathology or disease process. * Has a documented infection other than COVID-19 * Pregnant or lactating women who are breast feeding or planning on either during the study * 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 a high risk of progressing to severe COVID-19 per CDC's risk stratification (See: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html) * Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who have COVID-19-related visit or hospitalization | Baseline through Day 29 | Proportion of subjects who have COVID-19-related urgent medically-attended visit, emergency department assessment or hospitalization through D29 = COVID-19-related visits or hospitalization (CRVHD29) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29 | Baseline through Day 29 | Proportion of subjects alive and free of hospitalization ˃ 24h duration for acute COVID-19 illness management through D29 |
| Viral load change from baseline to D8 | Baseline to Day 8 | Viral load change from baseline to D8 based on RT-PCR determined COVID-19 viral titers (Log-10 copies/mL) |
| Change in WHO Clinical Progression Scale score | Baseline to Day 8 and Day 29 | Change in WHO Clinical Progression score at D8 and D29 (score of 0-10, with lower score meaning better outcome) |
| Viral load change from baseline to D29 | Baseline to Day 29 | Viral load change from baseline to D29, based on reverse-transcriptase polymerase chain reaction (RT-PCR) determined COVID-19 viral titres (Log-10 copies/mL) |
Countries
United States
Outcome results
None listed