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Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04883138
Recruitment Status : Recruiting
First Posted : May 12, 2021
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
GigaGen, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of single ascending IV dose administrations of GIGA-2050 in patients hospitalized with COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: GIGA-2050 Phase 1

Detailed Description:
This is a Phase 1, first in human (FIH) study utilizing a 3+3 design to assess the safety and pharmacology of single ascending doses (SAD) of GIGA-2050 in patients hospitalized with confirmed COVID-19. Participants will receive a single intravenous (IV) infusion dose of GIGA-2050 and followed for safety, pharmacology and efficacy assessments during hospitalization, after discharge (if applicable), and through study discontinuation or end of study visit (Day 56).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This is a Phase 1, first in human (FIH) study utilizing a 3+3 design to assess the safety and pharmacology of single ascending doses (SAD) of GIGA-2050 in patients hospitalized with confirmed COVID-19.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Single Ascending Dose Study of a Recombinant Hyperimmune Polyclonal Antibody Against SARS CoV-2 (GIGA-2050) in Patients Hospitalized With COVID-19
Actual Study Start Date : May 24, 2021
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : August 30, 2021

Arm Intervention/treatment
Experimental: 5 mg GIGA-2050 per kg BW
Participants will receive a single IV infusion of 5 mg GIGA-2050 per kg BW
Drug: GIGA-2050
Recombinant Hyperimmune Polyclonal Antibody

Experimental: 15 mg GIGA-2050 per kg BW
Participants will receive a single IV infusion of 15 mg GIGA-2050 per kg BW, or as determined by SRC review
Drug: GIGA-2050
Recombinant Hyperimmune Polyclonal Antibody

Experimental: 50 mg GIGA-2050 per kg BW
Participants will receive a single IV infusion of 50 mg GIGA-2050 per kg BW, or as determined by SRC review
Drug: GIGA-2050
Recombinant Hyperimmune Polyclonal Antibody




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 up to Day 56 ]
    Frequency of TEAEs graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  2. Incidence of dose limiting toxicities (DLTs) [ Time Frame: Day 1 up to Day 3 ]
    Frequency of DLTs at each dose level

  3. Change from baseline of vital signs, physical examination, and clinical laboratory assessments [ Time Frame: Day 1 up to Day 56 ]
    Numeric summaries of all observed findings and changes for vital signs, laboratory assessments, physical examinations, and ECG

  4. Incidence of infusion-related reactions (IRR) and hypersensitivity reactions [ Time Frame: Day 1 through Day 2 ]
    Frequency of IRR and hypersensitivity reactions


Secondary Outcome Measures :
  1. Pharmacological evaluation of single doses of GIGA-2050 [ Time Frame: Day 1 up to Day 28 ]
    Serum titers of antibodies directed against SARS CoV-2 will be measured for the pharmacological profile of single doses of GIGA-2050



Information from the National Library of Medicine

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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:

  • Participant is ≥ 18 years of age.
  • Positive result of a SARS CoV-2 RNA diagnostic test result ≤48 hours before enrollment, warranting hospital admission as per Investigator's judgement.
  • COVID-19 pneumonia findings on imaging (chest X-ray or CT Scan).
  • Requires oxygen supplementation with FIO2 approximately 30% or greater administered by nasal cannula, mask, or NIV.
  • Participants can be on other medication on-label to treat COVID-19 respiratory disease that the Investigator deems clinically relevant in combination with the study drug, including corticosteroids. Passage of 24 hours after administration of the EUA drug will be required prior to dosing GIGA-2050.
  • Men or non-lactating female participants who are surgically sterile or post-menopausal, or a Woman of Childbearing Potential (WCBP) with a negative pregnancy test at screening willing to use highly effective contraception methods.

Exclusion Criteria:

  • Acute respiratory failure requiring invasive mechanical ventilation or ECMO at enrollment.
  • Systolic Blood Pressure (SBP) <110 mmHg or heart rate >120 bpm.
  • Pre-existing heart failure or unstable angina or myocardial infarction in the last month prior to screening.
  • Pre-existing chronic respiratory condition(s).
  • Evidence of acute kidney injury, increase of serum creatinine of ≥1.5 x baseline, or urine output of <0.5mL/kg/hr sustained for at least 6 hours once volume repleted.
  • Aspartate aminotransferase (AST) ≥2.5 x ULN, alanine aminotransferase (ALT) ≥2.5 x ULN, and/or total bilirubin >1.5 x ULN, or severe hepatic impairment.
  • Known systemic hypersensitivity to recombinant antibody therapies.
  • Female participant who is pregnant.
  • Participant is expected to transfer to a non-investigative facility from the investigation site and cannot be monitored for compliance with protocol-required safety monitoring procedures.
  • Participants who are currently participating or have participated in another clinical trial within 30 days prior to screening.

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): NCT04883138


Contacts
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Contact: Jennifer Keller 650 268 4255 gigagentrials@gigagen.com

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Sean Liu, MD         
Sponsors and Collaborators
GigaGen, Inc.
Investigators
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Principal Investigator: Sean Liu, MD Icahn School of Medicine at Mount Sinai
Publications:
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Responsible Party: GigaGen, Inc.
ClinicalTrials.gov Identifier: NCT04883138    
Other Study ID Numbers: GG-GIGA-2050-001
First Posted: May 12, 2021    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No current plan to share IPD due to evaluation of potential DLTs.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GigaGen, Inc.:
SARS CoV-2
COVID-19