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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04454398
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Sorrento Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE June 30, 2020
First Posted Date  ICMJE July 1, 2020
Last Update Posted Date October 1, 2020
Actual Study Start Date  ICMJE September 17, 2020
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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
  • Incidence of laboratory abnormalities (safety) [ Time Frame: Randomization through study completion through Day 60 ]
    Clinically meaningful laboratory abnormalities
  • 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
  • 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
  • Anti-drug antibodies [ Time Frame: Randomization through study completion through Day 60 ]
    Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
Incidence of treatment-emergent adverse events (safety and tolerability of STI-1499) [ Time Frame: Randomization through study completion at 28 days ]
Types, frequencies, and severities of adverse events and their relationships to STI-1499
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
  • 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
  • Cmax of COVI-GUARD (PK) [ Time Frame: Randomization through study completion through Day 60 ]
    Maximum observed serum concentration (Cmax) of COVI-GUARD
  • t½ of COVI-GUARD (PK) [ Time Frame: Randomization through study completion through Day 60 ]
    Apparent serum terminal elimination half life (t½) of COVI-GUARD
  • Tmax of COVI-GUARD (PK) [ Time Frame: Randomization through study completion through Day 60 ]
    Time to Cmax (Tmax) of COVI-GUARD
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2020)
  • All-cause mortality [ Time Frame: Randomization through Day 28 ]
    All-cause mortality at Day 28
  • Change in clinical status [ Time Frame: Randomization to Day 7, 14, 28 ]
    Change from baseline in clinical status on a 7-point ordinal scale where higher score means better outcome (1=Death, 7=Not hospitalized and no limitations on activities)
  • Change in Sequential Organ Failure Assessment (SOFA) score [ Time Frame: Randomization to Day 7, 14, 28 ]
    Change from baseline in SOFA score where lower score means better outcome
  • Change in PaO2:FiO2 [ Time Frame: Randomization to Day 7, 14, 28 ]
    Change from baseline in ratio of partial pressure of arterial oxygen to fraction of inspired oxygen
  • Length of hospitalization [ Time Frame: Randomization up to Day 28 ]
    Length of hospitalization of participants (followed up to Day 28)
  • Percentage of participants requiring mechanical ventilation [ Time Frame: Randomization to Day 7, 14, 28 ]
    Percentage of participants requiring mechanical ventilation at Day 7, 14, and 28
  • Change in viral shedding [ Time Frame: Randomization to Day 7, 14, 21, 28 ]
    Change from baseline in viral shedding as assessed by RT-PCR
  • Immunogenicity of STI-1499 [ Time Frame: Randomization to Day 21, 28 ]
    Incidence of anti-drug antibody (ADA)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Covid-19
Intervention  ICMJE
  • 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
  • Drug: Placebo
    Diluent
Study Arms  ICMJE
  • 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
    Interventions:
    • Biological: COVI-GUARD
    • Other: Standard of Care
  • Placebo Comparator: Placebo
    Placebo administered via a single IV push injection, in addition to standard of care
    Interventions:
    • Other: Standard of Care
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 25, 2020)
33
Original Estimated Enrollment  ICMJE
 (submitted: June 30, 2020)
24
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mike Royal, MD (858) 203-4100 ext 4146 mroyal@sorrentotherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04454398
Other Study ID Numbers  ICMJE GRD-COV-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sorrento Therapeutics, Inc.
Study Sponsor  ICMJE Sorrento Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mike Royal, MD Sorrento Therapeutics
PRS Account Sorrento Therapeutics, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP