Status:
TERMINATED
Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients
Lead Sponsor:
GigaGen, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04883138
Start Date
May 24 2021
End Date
January 11 2022
Last Update
January 26 2022
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029