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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04883138
• Other study ID #: GG-GIGA-2050-001
• Status: Terminated
• Phase: Phase 1
• Start date: May 24, 2021
• Est. completion date: January 11, 2022

Study information

• Verified date: January 2022
• Source: GigaGen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 11, 2022
• Est. primary completion date: January 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• GIGA-2050
Recombinant Hyperimmune Polyclonal Antibody

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
GigaGen, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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, Büscher 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 1 up to Day 56
Primary	Incidence of dose limiting toxicities (DLTs)	Frequency of DLTs at each dose level	Day 1 up to Day 3
Primary	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	Day 1 up to Day 56
Primary	Incidence of infusion-related reactions (IRR) and hypersensitivity reactions	Frequency of IRR and hypersensitivity reactions	Day 1 through Day 2
Secondary	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	Day 1 up to Day 28