Covid-19
Conditions
Brief summary
Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19
Detailed description
This study is a randomized, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™), a COVID-19 targeting monoclonal antibody, in hospitalized patients with moderate COVID-19. Four dose levels will be tested: 10 mg, 30 mg, 100 mg, and 200 mg.
Interventions
OTHERStandard of Care
Standard of Care as determined by the Investigator
DRUGPlacebo
Diluent
BIOLOGICALCOVI-GUARD
COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein
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
* Evidence of moderate COVID-19, diagnosed standard RT-PCR assay or equivalent testing * Willing and able to comply with study procedures and follow-up visits * 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. However, if obtaining written informed consent is not possible, other procedures as provided in the March 27th, 2020 FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used.
Exclusion criteria
* Clinical signs indicative of severe COVID-19 * Rapidly progressive COVID-19 which is likely to progress to severe within 24 hours * Documented infection other than COVID-19 * Any medical condition that, in the Investigator's opinion, could adversely impact safety * Pregnant or lactating women * 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: Participants 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 | Randomization through study completion through Day 60 | Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα |
| Incidence of laboratory abnormalities (safety) | Randomization through study completion through Day 60 | Clinically meaningful laboratory abnormalities |
| SARS-CoV-2 viral load as assessed using various sample types | Randomization through study completion through Day 60 | Plasma samples and salivary samples are taken to correlate viral load with nasopharyngeal testing at various timepoints; stool or rectal swab samples are taken if possible for additional virologic assessments |
| Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital | Randomization up to study completion through Day 60 | Time from onset of COVID-19 symptoms to hospitalization and to treatment on Day 1, and if applicable, time to ICU admission, discharge from ICU and discharge from hospital |
| Anti-drug antibodies | Randomization through study completion through Day 60 | Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD |
| Incidence of adverse events (safety) | Randomization through study completion through Day 60 | Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD |
| Incidence of treatment-emergent adverse events (safety) | Randomization through study completion through Day 60 | Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD |
| Incidence of serious adverse events (safety) | Randomization through study completion through Day 60 | Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD |
| All-cause mortality at 29 and 60 days | Randomization through Day 29 and Day 60 | All-cause mortality at 29 and 60 days |
| Incidence of dose-limiting toxicities (safety) | Randomization through study completion through Day 60 | Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of COVI-GUARD (PK) | Randomization through study completion through Day 60 | Maximum observed serum concentration (Cmax) of COVI-GUARD |
| t½ of COVI-GUARD (PK) | Randomization through study completion through Day 60 | Apparent serum terminal elimination half life (t½) of COVI-GUARD |
| Tmax of COVI-GUARD (PK) | Randomization through study completion through Day 60 | Time to Cmax (Tmax) of COVI-GUARD |
| AUC of COVI-GUARD (PK) | Randomization through study completion through Day 60 | Area under the serum concentration-time curve (AUC) of COVI-GUARD |
Outcome results
None listed