COVID-19
Conditions
Keywords
COVID19, COVID-19
Brief summary
This is prospective double-blind study in the United States is designed to investigate the efficacy and safety of a single dose of COVI-DROPS or matched placebo in outpatient adults with mild symptoms associated with COVID-19 and a recent positive COVID-19 test.
Detailed description
Subjects will be randomized 2:1 to receive a single dose of COVI-DROPS (40 mg) or placebo in a double-blind manner. Investigational product (COVI-DROP or placebo) will be administered once on Study Day 1 and followed to Day 29. Subjects will be stratified based upon prior history of infection or vaccination versus the group who is unvaccinated and not previously infected with COVID-19.
Interventions
BIOLOGICALCOVI-DROPS
COVI-DROPS is a fully human monoclonal antibody that 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 No maximum
Healthy volunteers
No
Inclusion criteria
* Positive for COVID-19 with any approved RT-PCR or rapid antigen test within 7 days of planned treatment * Have mild illness/symptoms based upon NIH criteria. The NIH illness severity definition for mild states as follows: Individuals who have any of the various signs and symptoms of COVID-19 (e.g., fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging. * Be in good health as judged by investigator using screening medical history and physical examination. Participants who are otherwise healthy with a stable chronic medical condition may enroll * A prior COVID-19 infection in the past from which the subject fully recovered or a previously unknown asymptomatic infection is allowed, as is any previous COVID-19 vaccination * 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 the 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) * Currently using chronic oxygen therapy due to an underlying comorbidity and requires an increase in baseline oxygen flow rate due to COVID-19 infection * Is an immunocompromised subject even if previously fully vaccinated against COVID-19 or recovered from a prior COVID-19 infection * Has an active documented infection other than COVID-19 * 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 * Pregnant or lactating women who are breast feeding or planning on either during the study * Has received within the 30 days prior to screening or is planning on receiving an EUA-cleared monoclonal antibody (mAb) during the study * Has participated or is participating in a clinical research study evaluating COVID-19 convalescent plasma, other non-EUA-cleared mAbs against COVID-19 or intravenous immunoglobulin within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects who have a COVID-19-related visit or hospitalization | Baseline through Day 29 | Proportion of subjects with COVID-19-related urgent medically attended visits, emergency department assessments, hospitalizations ≥ 24h or all-cause death through Day 29 (D29) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral load change from baseline to Day 15 (D15) | Baseline through Day 15 | Viral load change from baseline to D15 based on nasal quantitative reverse transcription polymerase chain reaction (RT-PCR) COVID-19 viral titers (Log-10 copies/mL). Includes viral load change for subjects in the unvaccinated/no prior infection group as well as the vaccinated/prior infection group |
| Proportion of subjects who have a COVID-19-related visit or hospitalization based on stratification groups | Baseline to Day 29 | For each of the unvaccinated/no prior infection group or the vaccinated/prior infection group, proportion of subjects with COVID-19-related urgent medically attended visits, emergency department assessments, hospitalizations ≥ 24h or all-cause death through D29 |
Outcome results
None listed