<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04454398</url>
  </required_header>
  <id_info>
    <org_study_id>GRD-COV-101</org_study_id>
    <nct_id>NCT04454398</nct_id>
  </id_info>
  <brief_title>Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sorrento Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sorrento Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Randomized, placebo-controlled study to evaluate the safety, pharmacokinetics and efficacy of&#xD;
      a single dose of STI-1499 (COVI-GUARD™) in hospitalized patients with moderate COVID-19&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized, double-blind, placebo-controlled study to evaluate the safety,&#xD;
      pharmacokinetics and efficacy of a single dose of STI-1499 (COVI-GUARD™), a COVID-19&#xD;
      targeting monoclonal antibody, in hospitalized patients with moderate COVID-19. Four dose&#xD;
      levels will be tested: 10 mg, 30 mg, 100 mg, and 200 mg.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Difficulty recruiting&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events (safety)</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of treatment-emergent adverse events (safety)</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of serious adverse events (safety)</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>All-cause mortality at 29 and 60 days</measure>
    <time_frame>Randomization through Day 29 and Day 60</time_frame>
    <description>All-cause mortality at 29 and 60 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of dose-limiting toxicities (safety)</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of laboratory abnormalities (safety)</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>Clinically meaningful laboratory abnormalities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2 viral load as assessed using various sample types</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital</measure>
    <time_frame>Randomization up to study completion through Day 60</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Anti-drug antibodies</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cytokine levels</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUC of COVI-GUARD (PK)</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>Area under the serum concentration-time curve (AUC) of COVI-GUARD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax of COVI-GUARD (PK)</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>Maximum observed serum concentration (Cmax) of COVI-GUARD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t½ of COVI-GUARD (PK)</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>Apparent serum terminal elimination half life (t½) of COVI-GUARD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax of COVI-GUARD (PK)</measure>
    <time_frame>Randomization through study completion through Day 60</time_frame>
    <description>Time to Cmax (Tmax) of COVI-GUARD</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Covid-19</condition>
  <arm_group>
    <arm_group_label>COVI-GUARD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered via a single IV push injection, in addition to standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>COVI-GUARD</intervention_name>
    <description>COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein</description>
    <arm_group_label>COVI-GUARD</arm_group_label>
    <other_name>STI-1499</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of Care as determined by the Investigator</description>
    <arm_group_label>COVI-GUARD</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Diluent</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Evidence of moderate COVID-19, diagnosed standard RT-PCR assay or equivalent testing&#xD;
&#xD;
          -  Willing and able to comply with study procedures and follow-up visits&#xD;
&#xD;
          -  Subject or family member/caregiver must have provided written informed consent which&#xD;
             includes signing the institutional review board approved consent form prior to&#xD;
             participating in any study related activity. However, if obtaining written informed&#xD;
             consent is not possible, other procedures as provided in the March 27th, 2020 FDA&#xD;
             Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,&#xD;
             Question 10, may be used.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical signs indicative of severe COVID-19&#xD;
&#xD;
          -  Rapidly progressive COVID-19 which is likely to progress to &quot;severe&quot; within 24 hours&#xD;
&#xD;
          -  Documented infection other than COVID-19&#xD;
&#xD;
          -  Any medical condition that, in the Investigator's opinion, could adversely impact&#xD;
             safety&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Has participated, or is participating, in a clinical research study evaluating&#xD;
             COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or&#xD;
             intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the&#xD;
             investigational product (whichever is longer) prior to the screening visit. Note:&#xD;
             Participants who have been prescribed hydroxychloroquine or chloroquine with or&#xD;
             without azithromycin or other approved products for the off-label treatment of&#xD;
             COVID-19 prior to study enrollment may be included and may continue to receive these&#xD;
             agents so long as the dose remains stable. Additionally, any approved or authorized&#xD;
             treatment (e.g., remdesivir, dexamethasone or treatments approved under an Emergency&#xD;
             Use Authorization) is allowed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mike Royal, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sorrento Therapeutics</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>January 6, 2021</last_update_submitted>
  <last_update_submitted_qc>January 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04454398
org study id: GRD-COV-101
nct id: NCT04454398
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Incidence of adverse events (safety)
time frame: Randomization through study completion through Day 60
description: Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD
measure: Incidence of treatment-emergent adverse events (safety)
time frame: Randomization through study completion through Day 60
description: Types, frequencies, and severities of treatment-emergent adverse events and their relationships to COVI-GUARD
measure: Incidence of serious adverse events (safety)
time frame: Randomization through study completion through Day 60
description: Types, frequencies, and severities of serious adverse events and their relationships to COVI-GUARD
measure: All-cause mortality at 29 and 60 days
time frame: Randomization through Day 29 and Day 60
description: All-cause mortality at 29 and 60 days
measure: Incidence of dose-limiting toxicities (safety)
time frame: Randomization through study completion through Day 60
description: Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions
measure: Incidence of laboratory abnormalities (safety)
time frame: Randomization through study completion through Day 60
description: Clinically meaningful laboratory abnormalities
measure: SARS-CoV-2 viral load as assessed using various sample types
time frame: Randomization through study completion through Day 60
description: 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: Time to hospitalization, treatment, ICU admission, and discharge from ICU and/or hospital
time frame: Randomization up to study completion through Day 60
description: 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
measure: Anti-drug antibodies
time frame: Randomization through study completion through Day 60
description: Presence and levels of anti-drug antibodies (ADA) directed to COVI-GUARD
measure: Cytokine levels
time frame: Randomization through study completion through Day 60
description: Levels of cytokines including EGF, IFNγ, IL-1β, IL-6, IL-8, IL-10, and TNFα
measure: AUC of COVI-GUARD (PK)
time frame: Randomization through study completion through Day 60
description: Area under the serum concentration-time curve (AUC) of COVI-GUARD
measure: Cmax of COVI-GUARD (PK)
time frame: Randomization through study completion through Day 60
description: Maximum observed serum concentration (Cmax) of COVI-GUARD
measure: t½ of COVI-GUARD (PK)
time frame: Randomization through study completion through Day 60
description: Apparent serum terminal elimination half life (t½) of COVI-GUARD
measure: Tmax of COVI-GUARD (PK)
time frame: Randomization through study completion through Day 60
description: Time to Cmax (Tmax) of COVI-GUARD
arm group label: COVI-GUARD
arm group type: Experimental
description: 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
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered via a single IV push injection, in addition to standard of care
intervention type: Biological
intervention name: COVI-GUARD
description: COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein
arm group label: COVI-GUARD
other name: STI-1499
intervention type: Other
intervention name: Standard of Care
description: Standard of Care as determined by the Investigator
arm group label: COVI-GUARD
arm group label: Placebo
intervention type: Drug
intervention name: Placebo
description: Diluent
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mike Royal, MD
role: Study Director
affiliation: Sorrento Therapeutics
country: United States
responsible party type: Sponsor
mesh term: COVID-19