Clinical trial NCT04883138: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID-19
Keywords: SARS CoV-2
COVID-19
Lead sponsor: GigaGen, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Day 1 up to Day 56
measure: Incidence of dose limiting toxicities (DLTs)
timeFrame: Day 1 up to Day 3
measure: Change from baseline of vital signs, physical examination, and clinical laboratory assessments
timeFrame: Day 1 up to Day 56
measure: Incidence of infusion-related reactions (IRR) and hypersensitivity reactions
timeFrame: Day 1 through Day 2
Secondary outcomes:
measure: Pharmacological evaluation of single doses of GIGA-2050
timeFrame: Day 1 up to Day 28
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Sean Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.