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

Primary Purpose

COVID-19

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

GIGA-2050

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS CoV-2, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

5 mg GIGA-2050 per kg BW

15 mg GIGA-2050 per kg BW

50 mg GIGA-2050 per kg BW

Arm Description

Participants will receive a single IV infusion of 5 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

Participants will receive a single IV infusion of 50 mg GIGA-2050 per kg BW, or as determined by SRC review

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs)

Frequency of TEAEs graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Incidence of dose limiting toxicities (DLTs)

Frequency of DLTs at each dose level

Change from baseline of vital signs, physical examination, and clinical laboratory assessments

Numeric summaries of all observed findings and changes for vital signs, laboratory assessments, physical examinations, and ECG

Incidence of infusion-related reactions (IRR) and hypersensitivity reactions

Frequency of IRR and hypersensitivity reactions

Secondary Outcome Measures

Pharmacological evaluation of single doses of GIGA-2050

Serum titers of antibodies directed against SARS CoV-2 will be measured for the pharmacological profile of single doses of GIGA-2050

Full Information

NCT ID

NCT04883138

First Posted

May 4, 2021

Last Updated

January 11, 2022

Sponsor

GigaGen, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04883138

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Terminated

Why Stopped

Study stopped for commercial reasons.

Study Start Date

May 24, 2021 (Actual)

Primary Completion Date

January 11, 2022 (Actual)

Study Completion Date

January 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GigaGen, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

SARS CoV-2, COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

5 mg GIGA-2050 per kg BW

Arm Type

Experimental

Arm Description

Participants will receive a single IV infusion of 5 mg GIGA-2050 per kg BW

Arm Title

15 mg GIGA-2050 per kg BW

Arm Type

Experimental

Arm Description

Participants will receive a single IV infusion of 15 mg GIGA-2050 per kg BW, or as determined by SRC review

Arm Title

50 mg GIGA-2050 per kg BW

Arm Type

Experimental

Arm Description

Participants will receive a single IV infusion of 50 mg GIGA-2050 per kg BW, or as determined by SRC review

Intervention Type

Drug

Intervention Name(s)

GIGA-2050

Intervention Description

Recombinant Hyperimmune Polyclonal Antibody

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events (TEAEs)

Description

Frequency of TEAEs graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time Frame

Day 1 up to Day 56

Title

Incidence of dose limiting toxicities (DLTs)

Description

Frequency of DLTs at each dose level

Time Frame

Day 1 up to Day 3

Title

Change from baseline of vital signs, physical examination, and clinical laboratory assessments

Description

Numeric summaries of all observed findings and changes for vital signs, laboratory assessments, physical examinations, and ECG

Time Frame

Day 1 up to Day 56

Title

Incidence of infusion-related reactions (IRR) and hypersensitivity reactions

Description

Frequency of IRR and hypersensitivity reactions

Time Frame

Day 1 through Day 2

Secondary Outcome Measure Information:

Title

Pharmacological evaluation of single doses of GIGA-2050

Description

Serum titers of antibodies directed against SARS CoV-2 will be measured for the pharmacological profile of single doses of GIGA-2050

Time Frame

Day 1 up to Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sean Liu, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No current plan to share IPD due to evaluation of potential DLTs.

Citations:

PubMed Identifier

33859400

Citation

Keating SM, Mizrahi RA, Adams MS, Asensio MA, Benzie E, Carter KP, Chiang Y, Edgar RC, Gautam BK, Gras A, Leong J, Leong R, Lim YW, Manickam VA, Medina-Cucurella AV, Niedecken AR, Saini J, Simons JF, Spindler MJ, Stadtmiller K, Tinsley B, Wagner EK, Wayham N, Tracy L, Lundberg CV, Buscher D, Terencio JV, Roalfe L, Pearce E, Richardson H, Goldblatt D, Ramjag AT, Carrington CVF, Simmons G, Muench MO, Chamow SM, Monroe B, Olson C, Oguin TH, Lynch H, Jeanfreau R, Mosher RA, Walch MJ, Bartley CR, Ross CA, Meyer EH, Adler AS, Johnson DS. Generation of recombinant hyperimmune globulins from diverse B-cell repertoires. Nat Biotechnol. 2021 Aug;39(8):989-999. doi: 10.1038/s41587-021-00894-8. Epub 2021 Apr 15.

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

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