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History of Changes for Study: NCT04454398
Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19
Latest version (submitted January 6, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 30, 2020 None (earliest Version on record)
2 June 30, 2020 Study Identification and Study Status
3 July 24, 2020 Contacts/Locations, Study Description, Study Status, Arms and Interventions and Study Design
4 August 25, 2020 Outcome Measures, Arms and Interventions, Study Status, Study Design, Study Identification, Study Description and Eligibility
5 September 29, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
6 October 26, 2020 Contacts/Locations and Study Status
7 November 19, 2020 Contacts/Locations and Study Status
8 January 6, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Changes (Side-by-Side) for Study: NCT04454398
November 19, 2020 (v7) -- January 6, 2021 (v8)

Changes in: Study Status, Contacts/Locations and Study Design

Study Identification
Unique Protocol ID: GRD-COV-101 GRD-COV-101
Brief Title: Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19 Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19
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 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
Secondary IDs:
Study Status
Record Verification: November 2020 January 2021
Overall Status: Recruiting Withdrawn
Study Start: September 17, 2020 September 2020
Primary Completion: February 2021 [Anticipated ] January 2021 [Anticipated ]
Study Completion: February 2021 [Anticipated ] January 2021 [Anticipated ]
First Submitted: June 30, 2020 June 30, 2020
First Submitted that
Met QC Criteria:
June 30, 2020 June 30, 2020
First Posted: July 1, 2020 [Actual ] July 1, 2020 [Actual ]
Last Update Submitted that
Met QC Criteria:
November 19, 2020 January 6, 2021
Last Update Posted: November 20, 2020 [Actual ] January 8, 2021 [Actual ]
Sponsor/Collaborators
Sponsor: Sorrento Therapeutics, Inc. Sorrento Therapeutics, Inc.
Responsible Party: Sponsor Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: Yes Yes
U.S. FDA-regulated Device: No No
Data Monitoring: Yes Yes
Study Description
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 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. 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.
Conditions
Conditions: Covid-19 Covid-19
Keywords:
Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 1Phase 1
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 22
Masking: Double (Participant, Investigator)Double (Participant, Investigator)
Allocation: RandomizedRandomized
Enrollment: 33 [Anticipated ] 0 [Actual ]
Arms and Interventions
Arms Assigned Interventions
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 Names:
  • STI-1499
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
Standard of Care
Standard of Care as determined by the Investigator
Drug: Placebo
Diluent
Outcome Measures
Primary Outcome Measures:
1. Incidence of adverse events (safety)
Types, frequencies, and severities of adverse events and their relationships to COVI-GUARD

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

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

[Time Frame: 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

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

[Time Frame: 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

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

[Time Frame: Randomization through Day 29 and Day 60 ]
5. Incidence of dose-limiting toxicities (safety)
Dose-limiting toxicities, particularly presence of acute or delayed hypersensitivity reactions

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

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

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

[Time Frame: Randomization through study completion through Day 60 ]
7. 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

[Time Frame: 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

[Time Frame: Randomization through study completion through Day 60 ]
8. 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

[Time Frame: Randomization up to 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

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

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

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

[Time Frame: 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

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

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

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

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

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

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

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

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

[Time Frame: Randomization through study completion through Day 60 ]
Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age:
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
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.

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.
Contacts/Locations
Central Contact: Mike Royal, MD
Telephone: (858) 203-4100 Ext. 4146
Email: mroyal@sorrentotherapeutics.com
Study Officials: Mike Royal, MD
Study Director
Sorrento Therapeutics
Mike Royal, MD
Study Director
Sorrento Therapeutics
Locations: United States, Pennsylvania
Temple University Lung Center
[Recruiting]
Philadelphia, Pennsylvania, United States, 19140
Contact: Gerard Criner, MD
Principal Investigator: Gerard Criner, MD
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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