Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A 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

Conditions
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Covid-19

Intervention / Treatment
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* Biological: COVI-GUARD
* Other: Standard of Care
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVI-GUARD<br>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 | Biological: COVI-GUARD<br>* COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein<br>* Other names: STI-1499;Other: Standard of Care<br>* Standard of Care as determined by the Investigator<br>|
| Placebo Comparator: Placebo<br>Placebo administered via a single IV push injection, in addition to standard of care | Other: Standard of Care<br>* Standard of Care as determined by the Investigator<br>Drug: Placebo<br>* Diluent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |