COVID-19Phase 1NCT04883138
Recombinant Hyperimmune Polyclonal Antibody (GIGA-2050) in COVID-19 Patients
A Phase 1 study testing GIGA-2050 in people with COVID-19, run by GigaGen, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- GIGA-2050
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2021to 11 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
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
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.
Read the 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).
- Conditions
- COVID-19
- Being tested
- GIGA-2050
- Keywords
- SARS CoV-2, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIGA-2050Drug
Recombinant Hyperimmune Polyclonal Antibody
| Study group | Role | What they receive |
|---|---|---|
| 5 mg GIGA-2050 per kg BW | Experimental | Participants will receive a single IV infusion of 5 mg GIGA-2050 per kg BW Receives: 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 Receives: 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 Receives: Drug: GIGA-2050 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 up to Day 56
Incidence of dose limiting toxicities (DLTs)
Frequency of DLTs at each dose level
Measured: 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
Measured: Day 1 up to Day 56
Incidence of infusion-related reactions (IRR) and hypersensitivity reactions
Frequency of IRR and hypersensitivity reactions
Measured: Day 1 through Day 2
Secondary outcomes (1)
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
Measured: Day 1 up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start24 May 2021
- Primary completion11 Jan 2022
- Study completion11 Jan 2022
Why it stopped: Study stopped for commercial reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- GigaGen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sean Liu, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883138
- Sponsor's protocol ID
- GG-GIGA-2050-001
- Status last verified
- Jan 2022
- First submitted
- 4 May 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share IPD due to evaluation of potential DLTs.
Publications
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.
PubMed 33859400
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04883138
- Acronym / sponsor ID
- GG-GIGA-2050-001
- Conditions
- COVID-19
- Keywords
- SARS CoV-2, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped for commercial reasons.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GigaGen, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 May 2021 (actual)
- Primary completion
- 11 Jan 2022 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 5 mg GIGA-2050 per kg BW | Experimental | Drug: GIGA-2050Participants will receive a single IV infusion of 5 mg GIGA-2050 per kg BW |
| 15 mg GIGA-2050 per kg BW | Experimental | Drug: GIGA-2050Participants will receive a single IV infusion of 15 mg GIGA-2050 per kg BW, or as determined by SRC review |
| 50 mg GIGA-2050 per kg BW | Experimental | Drug: GIGA-2050Participants will receive a single IV infusion of 50 mg GIGA-2050 per kg BW, or as determined by SRC review |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIGA-2050Recombinant Hyperimmune Polyclonal Antibody | Drug | 15 mg GIGA-2050 per kg BW, 5 mg GIGA-2050 per kg BW, 50 mg GIGA-2050 per kg BW |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Day 1 up to Day 56
Frequency of TEAEs graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Incidence of dose limiting toxicities (DLTs)
Time frame: Day 1 up to Day 3
Frequency of DLTs at each dose level
Change from baseline of vital signs, physical examination, and clinical laboratory assessments
Time frame: Day 1 up to Day 56
Numeric summaries of all observed findings and changes for vital signs, laboratory assessments, physical examinations, and ECG
Incidence of infusion-related reactions (IRR) and hypersensitivity reactions
Time frame: Day 1 through Day 2
Frequency of IRR and hypersensitivity reactions
1 secondary outcome
Pharmacological evaluation of single doses of GIGA-2050
Time frame: Day 1 up to Day 28
Results and safety
The study was stopped early (reason given: Study stopped for commercial reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Background: PubMed 33859400Keating 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.
- Individual participant dataSharing planned: No. No current plan to share IPD due to evaluation of potential DLTs.
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Liu, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GIGA-2050 in people with COVID-19, run by GigaGen, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study stopped for commercial reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Day 1 up to Day 56). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04883138, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.