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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: GIGA-2050


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5 mg GIGA-2050 per kg BW<br>Participants will receive a single IV infusion of 5 mg GIGA-2050 per kg BW | Drug: GIGA-2050<br>* Recombinant Hyperimmune Polyclonal Antibody<br>|
| Experimental: 15 mg GIGA-2050 per kg BW<br>Participants will receive a single IV infusion of 15 mg GIGA-2050 per kg BW, or as determined by SRC review | Drug: GIGA-2050<br>* Recombinant Hyperimmune Polyclonal Antibody<br>|
| Experimental: 50 mg GIGA-2050 per kg BW<br>Participants will receive a single IV infusion of 50 mg GIGA-2050 per kg BW, or as determined by SRC review | Drug: GIGA-2050<br>* Recombinant Hyperimmune Polyclonal Antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS CoV-2, COVID-19