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Difficulty recruiting
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVI-GUARD | Experimental | COVI-GUARD (STI-1499) administered via a single IV push injection at a dose of 10 mg, 30 mg, 100 mg, or 200 mg, in addition to standard of care |
|
| Placebo | Placebo Comparator | Placebo administered via a single IV push injection, in addition to standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVI-GUARD | Biological | COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (safety) | Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD | Randomization through study completion through Day 60 |
| Incidence of treatment-emergent adverse events (safety) | Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD | Randomization through study completion through Day 60 |
| Incidence of serious adverse events (safety) | Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD | Randomization through study completion through Day 60 |
| All-cause mortality at 29 and 60 days | All-cause mortality at 29 and 60 days | Randomization through Day 29 and Day 60 |
| Incidence of dose-limiting toxicities (safety) | Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions | Randomization through study completion through Day 60 |
| Incidence of laboratory abnormalities (safety) | Clinically meaningful laboratory abnormalities | Randomization through study completion through Day 60 |
| SARS-CoV-2 viral load as assessed using various sample types | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of COVI-GUARD (PK) | Area under the serum concentration-time curve (AUC) of COVI-GUARD | Randomization through study completion through Day 60 |
| Cmax of COVI-GUARD (PK) | Maximum observed serum concentration (Cmax) of COVI-GUARD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mike Royal, MD | Sorrento Therapeutics | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473343 | Derived | Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000714227 | STI-2020 |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care | Other | Standard of Care as determined by the Investigator |
|
| Placebo | Drug | Diluent |
|
| Randomization through study completion through Day 60 |
| Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital | 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 | Randomization up to study completion through Day 60 |
| Anti-drug antibodies | Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD | Randomization through study completion through Day 60 |
| Cytokine levels | Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα | Randomization through study completion through Day 60 |
| Randomization through study completion through Day 60 |
| t½ of COVI-GUARD (PK) | Apparent serum terminal elimination half life (t½) of COVI-GUARD | Randomization through study completion through Day 60 |
| Tmax of COVI-GUARD (PK) | Time to Cmax (Tmax) of COVI-GUARD | Randomization through study completion through Day 60 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |