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

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ClinicalTrials.gov Identifier: NCT04454398
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Covid-19 Biological: COVI-GUARD Other: Standard of Care Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 17, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Experimental: COVI-GUARD
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
COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein
Other Name: STI-1499

Other: Standard of Care
Standard of Care as determined by the Investigator

Placebo Comparator: Placebo
Placebo administered via a single IV push injection, in addition to standard of care
Other: Standard of Care
Standard of Care as determined by the Investigator

Drug: Placebo
Diluent




Primary Outcome Measures :
  1. Incidence of adverse events (safety) [ Time Frame: Randomization through study completion through Day 60 ]
    Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD

  2. Incidence of treatment-emergent adverse events (safety) [ Time Frame: Randomization through study completion through Day 60 ]
    Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD

  3. Incidence of serious adverse events (safety) [ Time Frame: Randomization through study completion through Day 60 ]
    Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD

  4. All-cause mortality at 29 and 60 days [ Time Frame: Randomization through Day 29 and Day 60 ]
    All-cause mortality at 29 and 60 days

  5. Incidence of dose-limiting toxicities (safety) [ Time Frame: Randomization through study completion through Day 60 ]
    Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions

  6. Incidence of laboratory abnormalities (safety) [ Time Frame: Randomization through study completion through Day 60 ]
    Clinically meaningful laboratory abnormalities

  7. SARS-CoV-2 viral load as assessed using various sample types [ Time Frame: 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

  8. Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital [ Time Frame: 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

  9. Anti-drug antibodies [ Time Frame: Randomization through study completion through Day 60 ]
    Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD

  10. Cytokine levels [ Time Frame: Randomization through study completion through Day 60 ]
    Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα


Secondary Outcome Measures :
  1. AUC of COVI-GUARD (PK) [ Time Frame: Randomization through study completion through Day 60 ]
    Area under the serum concentration-time curve (AUC) of COVI-GUARD

  2. Cmax of COVI-GUARD (PK) [ Time Frame: Randomization through study completion through Day 60 ]
    Maximum observed serum concentration (Cmax) of COVI-GUARD

  3. t½ of COVI-GUARD (PK) [ Time Frame: Randomization through study completion through Day 60 ]
    Apparent serum terminal elimination half life (t½) of COVI-GUARD

  4. Tmax of COVI-GUARD (PK) [ Time Frame: Randomization through study completion through Day 60 ]
    Time to Cmax (Tmax) of COVI-GUARD



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04454398


Contacts
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Contact: Mike Royal, MD (858) 203-4100 ext 4146 mroyal@sorrentotherapeutics.com

Locations
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United States, Pennsylvania
Temple University Lung Center Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Gerard Criner, MD         
Principal Investigator: Gerard Criner, MD         
Sponsors and Collaborators
Sorrento Therapeutics, Inc.
Investigators
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Study Director: Mike Royal, MD Sorrento Therapeutics
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Responsible Party: Sorrento Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04454398    
Other Study ID Numbers: GRD-COV-101
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No