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

NCT04883138 | Terminated Phase 1 FDA Drug

• 1 other identifier: GG-GIGA-2050-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

SARS CoV-2; COVID-19

Outcome Measures

Primary Outcomes (4)

• 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

• Incidence of dose limiting toxicities (DLTs)

  Frequency of DLTs at each dose level

  Day 1 up to Day 3

• 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

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

  Frequency of IRR and hypersensitivity reactions

  Day 1 through Day 2

Secondary Outcomes (1)

• Pharmacological evaluation of single doses of GIGA-2050

  Day 1 up to Day 28

Study Arms (3)

5 mg GIGA-2050 per kg BW

EXPERIMENTAL

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

Drug: GIGA-2050

15 mg GIGA-2050 per kg BW

EXPERIMENTAL

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

Drug: GIGA-2050

50 mg GIGA-2050 per kg BW

EXPERIMENTAL

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

Drug: GIGA-2050

Interventions

GIGA-2050 DRUG

Recombinant Hyperimmune Polyclonal Antibody

15 mg GIGA-2050 per kg BW; 5 mg GIGA-2050 per kg BW; 50 mg GIGA-2050 per kg BW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GigaGen, Inc.: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related 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, 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.

  PMID: 33859400 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

GIGA-2050

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sean Liu, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 12, 2021
• Study Start: May 24, 2021
• Primary Completion: January 11, 2022
• Study Completion: January 11, 2022
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)