COVID-19Phase 2NCT04480424
Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)
A Phase 2 study testing GAMUNEX-C and Standard Medical Treatment in people with COVID-19, run by Grifols Therapeutics LLC at 18 sites in United States.
Trial summary
The purpose of the study is to determine if a high dose of Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29. 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?
- GAMUNEX-C and Standard Medical Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 18 sitesUnited States
- Study dates
- 17 Sep 2020to 25 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Hospitalized male or female subjects of ≥ 18 years of age at time of Screening who are being treated in the ICU for COVID-19 for not longer than 48 hours or for whom a decision has been made that COVID-19 disease severity warrants ICU admission.
- Has laboratory-confirmed novel coronavirus {SARS-CoV-2} infection as determined by qualitative polymerase chain reaction (PCR) (reverse transcriptase [RT]-PCR), or other United States Food and Drug Administration (FDA)-approved diagnostic assay for COVID-19 in any specimen during the current hospital admission prior to randomization.
- Illness (symptoms of COVID-19 of any duration requiring ICU level care), and the following:
- Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT) scan, etc.), and
- Requiring mechanical ventilation and/or supplemental oxygen.
- Any one of the following related to COVID-19: i. Ferritin > 400 nanogram per milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) > 300 units per liter (U/L), iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram per liter (mg/L).
- Subject provides informed consent prior to initiation of any study procedures.
Who cannot join
- Clinical evidence of any significant acute or chronic disease or pathophysiologic manifestations (eg, complications of COVID-19 standard medical treatments) that, in the opinion of the investigator, may place the subject at undue medical risk.
- The subject has had a known (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or a past history of any hypersensitivity reactions to commercial immunoglobulin.
- A medical condition in which the infusion of additional fluid is contraindicated.
- Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the Principal Investigator not able to be reversed.
- Subjects with known (documented) thrombotic complications to polyclonal IVIG therapy in the past.
- Subjects with current or prior myocardial infarction, stroke, deep vein thrombosis, or thromboembolic event (within the past 12 months) or who have a history of thromboembolic events of unknown etiology.
Show all 14Show fewer
- Subjects with limitations of therapeutic effort.
- Female subjects who are pregnant or of child-bearing potential with a positive test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline.
- Subjects participating in another interventional clinical trial with investigational medical product or device.
- Known history of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or antiphospholipid syndrome.
- Presence of malignancy (either new diagnosis of malignancy or known residual disease) within the past 12 months.
- Creatinine at Screening is ≥ 4 mg/dL (or subject is dependent on dialysis/renal replacement therapy).
- Known Immunoglobulin A (IgA) deficiency with anti-IgA serum antibodies.
- Uncontrolled hypertension at the time of Screening (systolic blood pressure > 200 mm Hg) or refractory severe hypotension with sustained systolic blood pressure < 90 mm Hg unresponsive to vasopressors.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Summa Health
Akron, Ohio, 44304
Chandler Regional Medical Center
Chandler, Arizona, 85224
University of Illinois at Chicago
Chicago, Illinois, 60612
Southern California Research Center
Coronado, California, 92118
McLaren Flint
Flint, Michigan, 48532
University of Louisville
Louisville, Kentucky, 40202
McLaren Health Care-Macomb
Mount Clemens, Michigan, 48043
Columbia University Medical Center
New York, New York, 10032
CHI Health
Omaha, Nebraska, 68124
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Allegheny Health Network Research Institute
Pittsburgh, Pennsylvania, 15212
McLaren Health Care Oakland
Pontiac, Michigan, 48342
Louisiana State University Health Sciences Center
Shreveport, Louisiana, 71103
MultiCare Deaconess Hospital
Spokane, Washington, 99204
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405
CHRISTUS Health
Tyler, Texas, 75701
Via Christi Research
Wichita, Kansas, 67214
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27517
About this study
Official title: A Multicenter, Randomized, Open-label Parallel Group Pilot Study to Evaluate Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Subjects With COVID-19 Requiring Admission to the Intensive Care Unit
The purpose of the study is to determine if a high dose of Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.
- Conditions
- COVID-19
- Being tested
- GAMUNEX-C, Standard Medical Treatment
- Keywords
- Coronavirus Disease, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2, Coronavirus Infections, Coronaviridae Infections, Virus Diseases, Immunoglobulins, Antibodies, Gamma-globulins, Immunoglobulins, Intravenous, Immunologic Factors, Physiological Effects of Drugs
- Medical subject headings
- COVID-19, Coronavirus Infections, Coronaviridae Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAMUNEX-CBiological
Also called IGIV-C
Intravenous Immune Globulin (Human), 10% Caprylate/Chromatography Purified.
Standard Medical TreatmentDrug
SMT per local policies or guidelines.
| Study group | Role | What they receive |
|---|---|---|
| GAMUNEX-C + Standard Medical Treatment | Experimental | Participants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29. Receives: Biological: GAMUNEX-C; Drug: Standard Medical Treatment |
| Standard Medical Treatment | Active comparator | Participants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29. Receives: Drug: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality Rate Through Day 29
All-cause mortality rate is percentage of participants in each treatment group who experienced mortality up to Day 29.
Measured: Up to Day 29
Secondary outcomes (12)
Percentage of Participants With Actual Intensive Care Unit (ICU) Discharge Time
Percentage of participants who were discharged from ICU were recorded. Time to actual ICU discharge was defined as duration of actual ICU stay from Day 1 through Day 29.
Measured: Up to Day 29
Duration of Mechanical Ventilation
Duration (number of days) of ICU stay from post-randomization through Day 29 was calculated based on ICU admission and discharge (actual and medical equivalence) dates.
Measured: Up to Day 29
Percentage of Participants With Actual Hospital Discharge Time
Percentage of participants who were discharged from the hospital were recorded. Time to hospital discharge was defined as duration of hospitalization from Day 1 through Day 29.
Measured: Up to Day 29
Duration of Any Oxygen Use From Day 1 Through Day 29
Duration (number of days) of any oxygen use from Day 1 through Day 29 was calculated based on the start/stop dates.
Measured: Up to Day 29
Mean Change From Baseline in Ordinal Scale
The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status based on the following points: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Higher score indicated no severe illness. Mean change in Ordinal scale was evaluated by fitting a linear mixed-effects model for repeated measures (MMRM). The data is reported for average across all postbaseline.
Measured: Baseline up to Day 29
Absolute Change From Baseline in Ordinal Scale at Day 29
The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status based on the following points: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities. Higher score indicated no severe illness.
Measured: Baseline, Day 29
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status based on the following points: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen; 6) Not hospitalized, limitation on activities; 7) Not hospitalized, no limitations on activities.
Measured: Days 15 and 29
Percentage of Participants Who Develop Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome was defined based on Berlin criteria (chest imaging, origin of edema, oxygenation).
Measured: Days 1, 5, 15 and 29
Percentage of Participants Who Develop ARDS Distributed by Severity
ARDS was defined by Berlin's criteria as: 1) Timing is usually within 1 week of a known clinical insult or new or worsening respiratory symptoms 2) Chest imaging: bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules 3) Respiratory failure not fully explained by cardiac failure or fluid overload Need objective assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present 4) Oxygenation: Mild 200 mm Hg < partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ≤ 300 mm Hg with positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP) ≥ 5 cm H2Oc; Moderate 100 mm Hg < PaO2/FIO2 ≤ 200 mm Hg with PEEP ≥ 5 cm H2O; Severe PaO2/FIO2 ≤100 mm Hg with PEEP ≥ 5 cm H2O.
Measured: Days 1, 5, 15 and 29
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 5, Day 15, and Day 29
SOFA score is a mortality prediction score that is based on the degree of dysfunction of six organ systems. The score is calculated on admission and every 24 hours until discharge using the worst parameters measured during the prior 24 hours SOFA score ranges from 0 (no organ dysfunction) to 24 (highest possible score / organ dysfunction). Higher score indicated severe illness.
Measured: Days 5, 15, and 29
Change From Baseline in National Early Warning Score (NEWS)
NEWS is clinical scoring developed to improve detection of deterioration in ill participant. It is based on 7 clinical parameters: respiration rate, oxygen saturation, supplemental oxygen, systolic blood pressure (BP), pulse rate, level of consciousness, and temperature. A score of 0 and 2 was allocated to supplemental oxygen, 0 and 3 for level of consciousness and score of 0, 1, 2 and 3 for remaining parameters (i.e. respiration rate, oxygen saturation, systolic BP, pulse rate and temperature) where 0 = normal health condition to 3 = worst health condition; higher score indicated more severity. All scores were summed to get an aggregate score. Aggregate NEWS score ranged from 0 to 20, with higher scores meaning more severity/higher risk.
Measured: Baseline and Day 29
Percentage of Participants Achieving Clinical Response: NEWS ≤ 2 Maintained for 24 Hours
Percentage of participants who achieved clinical response (i.e the NEWS score ≤2 maintained for 24 hours from Day 1 through Day 29) was estimated using the Kaplan-Meier method.
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start17 Sep 2020
- Primary completion25 Aug 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Simon Mahler, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480424
- Sponsor's protocol ID
- GC2007
- Status last verified
- Oct 2022
- First submitted
- 20 Jul 2020
- Last updated
- 7 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label Parallel Group Pilot Study to Evaluate Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Subjects With COVID-19 Requiring Admission to the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04480424
- Acronym / sponsor ID
- GC2007
- Conditions
- COVID-19
- Keywords
- Coronavirus Disease, Severe acute respiratory syndrome coronavirus 2, SARS-CoV-2, Coronavirus Infections, Coronaviridae Infections, Virus Diseases, Immunoglobulins, Antibodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Posted 7 Oct 2022
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 the study is to determine if a high dose of Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) can reduce all-cause mortality versus SMT alone in hospitalized participants with COVID-19 requiring admission to the ICU through Day 29.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAMUNEX-C + Standard Medical Treatment | Experimental | Biological: GAMUNEX-C, Drug: Standard Medical TreatmentParticipants received 2 grams per kilogram (g/kg) of GAMUNEX-C, which was capped to a maximum of 160 g infusion intravenously (IV) for participants weighing more than 80 kg on Day 1. The 2 g/kg net total dose was divided either into infusions of 500 mg/kg body weight over 4 days or 400 mg/kg body weight over 5 days as per investigator's decision. Participants received standard of care interventions as per Principal Investigator's discretion from Day 1 up to Day 29. |
| Standard Medical Treatment | Active comparator | Drug: Standard Medical TreatmentParticipants received all standard of care interventions required as per Principal Investigator's discretion throughout the participant's hospitalization, from Day 1 to Day 29. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hospitalized male or female subjects of ≥ 18 years of age at time of Screening who are being treated in the ICU for COVID-19 for not longer than 48 hours or for whom a decision has been made that COVID-19 disease severity warrants ICU admission.
- Has laboratory-confirmed novel coronavirus {SARS-CoV-2} infection as determined by qualitative polymerase chain reaction (PCR) (reverse transcriptase [RT]-PCR), or other United States Food and Drug Administration (FDA)-approved diagnostic assay for COVID-19 in any specimen during the current hospital admission prior to randomization.
- Illness (symptoms of COVID-19 of any duration requiring ICU level care), and the following:
- Any one of the following related to COVID-19: i. Ferritin > 400 nanogram per milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) > 300 units per liter (U/L), iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram per liter (mg/L).
- Subject provides informed consent prior to initiation of any study procedures.
Key exclusion criteria (14 listed)
- Clinical evidence of any significant acute or chronic disease or pathophysiologic manifestations (eg, complications of COVID-19 standard medical treatments) that, in the opinion of the investigator, may place the subject at undue medical risk.
- The subject has had a known (documented) serious anaphylactic reaction to blood, any blood-derived or plasma product or a past history of any hypersensitivity reactions to commercial immunoglobulin.
- A medical condition in which the infusion of additional fluid is contraindicated.
- Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the Principal Investigator not able to be reversed.
- Subjects with known (documented) thrombotic complications to polyclonal IVIG therapy in the past.
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 |
|---|---|---|
| GAMUNEX-CAlso: IGIV-CIntravenous Immune Globulin (Human), 10% Caprylate/Chromatography Purified. | Biological | GAMUNEX-C + Standard Medical Treatment |
| Standard Medical TreatmentSMT per local policies or guidelines. | Drug | GAMUNEX-C + Standard Medical Treatment, Standard Medical Treatment |
Primary outcome
All-Cause Mortality Rate Through Day 29
Time frame: Up to Day 29
All-cause mortality rate is percentage of participants in each treatment group who experienced mortality up to Day 29.
12 secondary outcomes
Percentage of Participants With Actual Intensive Care Unit (ICU) Discharge Time
Time frame: Up to Day 29
Duration of Mechanical Ventilation
Time frame: Up to Day 29
Percentage of Participants With Actual Hospital Discharge Time
Time frame: Up to Day 29
Duration of Any Oxygen Use From Day 1 Through Day 29
Time frame: Up to Day 29
Mean Change From Baseline in Ordinal Scale
Time frame: Baseline up to Day 29
Absolute Change From Baseline in Ordinal Scale at Day 29
Time frame: Baseline, Day 29
Percentage of Participants in Each Severity Category of the 7-Point Ordinal Scale
Time frame: Days 15 and 29
Percentage of Participants Who Develop Acute Respiratory Distress Syndrome (ARDS)
Time frame: Days 1, 5, 15 and 29
Percentage of Participants Who Develop ARDS Distributed by Severity
Time frame: Days 1, 5, 15 and 29
Change From Baseline in Sequential Organ Failure Assessment (SOFA) Score at Day 5, Day 15, and Day 29
Time frame: Days 5, 15, and 29
Change From Baseline in National Early Warning Score (NEWS)
Time frame: Baseline and Day 29
Percentage of Participants Achieving Clinical Response: NEWS ≤ 2 Maintained for 24 Hours
Time frame: Day 29
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Simon Mahler, MD principal investigator
Wake Forest University Health Sciences
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GAMUNEX-C and Standard Medical Treatment in people with COVID-19, run by Grifols Therapeutics LLC at 18 sites 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
All-Cause Mortality Rate Through Day 29 (time frame: Up to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2022.