Covid19
Conditions
Keywords
covid-19
Brief summary
This is a randomized, placebo-controlled study to assess the safety, PK profile, and efficacy of COVI-AMG in subjects with COVID-19.
Detailed description
This is a multi-center, randomized, double-blind, placebo-controlled study followed by an expansion cohort phase designed to investigate the safety, PK profile, and efficacy of a single injection of COVI-AMG in outpatient subjects with COVID-19 but are not likely to require hospital admission within 24 hours. Subjects will receive one of the following treatments: 40 mg COVI-AMG, 100 mg COVI-AMG, 200 mg COVI-AMG, or placebo. Subjects will be followed for 60 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
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Initially, 2 subjects will be enrolled at the 40 mg dose level. If no safety concerns arise, 48 subjects will then be randomized 1:1:1:1 to receive 40 mg COVI-AMG, 100 mg COVI-AMG, 200 mg COVI-AMG, or placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be COVID-19 positive by RT-PCR or an equivalent test, using an appropriate sample such as nasopharyngeal \[NP\], nasal, oropharyngeal \[OP\], or salivary) ≤ 72 hours prior to randomization. A historical record of positive result from test conducted ≤ 72 hours prior to randomization is acceptable if it can be documented. * Must be asymptomatic OR have mild symptoms but not requiring imminent (within 24h) hospitalization. * 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 or family member/caregiver must have provided written informed consent which includes signing the institutional review board approved consent form prior to participating in any study related activity.
Exclusion criteria
* Have a documented infection other than COVID-19 that requires systemic treatment or in the investigator's opinion could interfere with the participant's safety or interfere with the assessments if enrolled in the study. * Have any medical condition that, in the Investigator's opinion, could adversely impact safety. * Be pregnant or lactating and breast feeding * 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. Note: subjects who have been prescribed hydroxychloroquine or chloroquine with or without azithromycin or other approved products for the off-label treatment of COVID-19 prior to study enrollment may be included and may continue to receive these agents so long as the dose remains stable. Additionally, any approved or authorized treatment (e.g., remdesivir, dexamethasone or treatments approved under an Emergency Use Authorization) is allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cytokine levels post-treatment | Randomization through study completion at Day 60 | Cytokine levels post-treatment including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα will be measured by ELISA |
| Incidence of clinically meaningful laboratory abnormalities (safety) | Randomization through study completion at Day 60 | Safety as assessed by incidence of clinically meaningful laboratory abnormalities |
| Viral load as assessed using plasma and salivary samples at various timepoints | Randomization through study completion at Day 60 | Viral load as assessed using plasma and salivary samples at various timepoints correlated with nasopharyngeal testing |
| Time from onset of COVID-19 symptoms to treatment (Day 1) | Day 1 | Time from onset of COVID-19 symptoms to treatment (Day 1) |
| Presence and levels of anti-drug antibodies directed to COVI-AMG | Randomization through study completion at Day 60 | Presence and levels of anti-drug antibodies directed to COVI-AMG |
| Incidence of adverse events by type, frequency, severity, and causality (safety) | Randomization through study completion at Day 60 | Safety as assessed by incidence of adverse events by type, frequency, severity, and causality |
| Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety) | Randomization through study completion at Day 60 | Safety as assessed by incidence of treatment-emergent adverse events by type, frequency, severity, and causality |
| Incidence of serious adverse events by type, frequency, severity, and causality (safety) | Randomization through study completion at Day 60 | Safety as assessed by incidence of serious adverse events by type, frequency, severity, and causality |
| Incidence of dose-limiting toxicities (safety) | Randomization through study completion at Day 60 | Safety as assessed by incidence of dose-limiting toxicities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of COVI-AMG (PK) | Randomization through study completion at Day 60 | Maximum observed serum concentration (Cmax) of COVI-AMG |
| Tmax of COVI-AMG (PK) | Randomization through study completion at Day 60 | Time to Cmax (Tmax) of COVI-AMG |
| t½ of COVI-AMG (PK) | Randomization through study completion at Day 60 | Apparent serum terminal elimination half life (t½) of COVI-AMG |
| AUC of COVI-AMG (PK) | Randomization through study completion at Day 60 | Area under the serum concentration-time curve (AUC) of COVI-AMG |
Outcome results
None listed