Covid-19Phase 3NCT04400058
Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
A Phase 3 study testing Octagam 10% and Saline Solution in people with Covid-19, run by Octapharma at 22 sites in 3 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease 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?
- Octagam 10% and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 22 sitesin 3 countries
- Study dates
- 1 Jun 2020to 1 Feb 2022
- Phase
- Phase 3
- 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
- Adult aged ≥18years old
- Provide voluntary, fully informed written and signed consent before any study-related procedures are conducted
- Able to understand and comply with the relevant aspects of the study protocol
- Laboratory (RT-PCR) confirmed COVID-19 infection on throat swab and/or sputum and/or lower respiratory tract samples
- Hospitalized with a resting room-air SpO2 of ≤93% or PaO2/FiO2 ratio <300mmHg. Measurement can be taken from documented source records in the 24 hours prior to screening
- Chest imaging confirming lung involvement
Who cannot join
- Existence of other evidence that can explain pneumonia including but not limited to: Influenza A virus, influenza B virus, bacterial pneumonia (as suggested by the combined clinical picture, radiological findings and known laboratory results [eg, elevated procalcitonin >0.5ng/mL and concomitant neutrophilia]), known fungal pneumonia, suspected fungal pneumonia based on compromised immune system with a history of past fungal infections, noninfectious causes, etc.
- Known history of serious allergic reactions, including anaphylaxis, to IVIG or its preparation components
- Subjects with a history of thromboembolic event (TEE) within the last 12 months, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease (Fontaine IV)
- Subjects with an underlying medical condition that can lead to hypercoagulable states and hyperviscosity such as antithrombin III deficiency, Factor V Leiden, Protein C deficiency, antiphospholipid syndrome and malignancy
- Known history of selective IgA deficiency with antibodies against IgA
- Subjects with conditions such as human immunodeficiency virus (HIV) infection, known acute or chronic hepatitis B or C (HBsAg positive or HCV ribonucleic acid (RNA) PCR positive or currently treated with antivirals), pulmonary fibrosis, elevated procalcitonin (> 0.5) with concomitant neutrophilia (elevated polys), heparin induced thrombocytopenia (HIT), and moderate to severe renal dysfunction (per investigator discretion based on estimated glomerular filtration rate [eGFR] <59 mL/min/1.73 m2, as defined by KDIGO Clinical Practice Guideline):
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- Moderately reduced GFR (G3a): GFR = 45 to 59 ml/min/1.73 m2
- Moderately reduced GFR (G3b): GFR = 30 to 44 ml/min/1.73 m2
- Severely reduced GFR (G4): GFR = 15 to 29 ml/min/1.73 m2
- Kidney failure (G5): GFR <15 ml/min/1.73 m2
- Currently requiring IMV (invasive mechanical ventilation or having received IMV during the last 30 days
- Known clinically significant preexisting lung, heart, or neuromuscular disease that, in the investigator's opinion, would impact subject's ability to complete study or may confound the study results
- Body weight >125 kg
- Women who are pregnant or breast-feeding
- Subjects who received COVID-19 convalescent plasma, IVIG products, anti-interleukin agents (eg, Tocilizumab), or interferons for their COVID-19 disease before enrollment or plan to receive this treatment during the course of the study
- Enrolled in other experimental interventional studies or taking experimental medications (ie, convalescent plasma). Diagnostic studies can be allowed if the anticipated total blood volume to be drawn across both studies and for therapeutic purposes does not exceed 450 mL over any 8-week period.
Trial locations and contacts
22 sites in 3 countries.
22 sites in 3 countries
United States15 sites
Octapharma Research Site
Charleston, South Carolina, 29401
Octapharma Research Site
Covington, Louisiana, 70433
Octapharma Research Site
Honolulu, Hawaii, 96813
Octapharma Research Site
Iowa City, Iowa, 52242
Octapharma Research Site
Las Vegas, Nevada, 89102
Octapharma Research Site
Loma Linda, California, 92354
Octapharma Research Site
Loma Linda, California, 92357
Octapharma Research Site
Midland, Michigan, 48670
Octapharma Research Site
Minot, North Dakota, 58701
Octapharma Research Site
Newport Beach, California, 92663
Octapharma Research Site
Orange, California, 92868
Octapharma Research Site
San Diego, California, 92123
Octapharma Research Site
Sheffield, Alabama, 35660
Octapharma Research Site
Tyler, Texas, 75708
Octapharma Research Site
Washington D.C., District of Columbia, 20007
Russia4 sites
Octapharma Research Site
Ivanovo, 153025
Octapharma Research Site
Moscow, 111539
Octapharma Research Site
Moscow, 129301
Octapharma Research Site
Ryazan, 390000
Ukraine3 sites
Octapharma Research Site
Ivano-Frankivsk, 76007
Octapharma Research Site
Kharkiv, 61096
Octapharma Research Site
Kremenchuk, 39623
About this study
Official title: Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease
- Conditions
- Covid-19
- Being tested
- Octagam 10%, Saline Solution
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octagam 10%Biological
Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
Saline SolutionOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Octagam 10% | Experimental | Octagam 10% Receives: Biological: Octagam 10% |
| Saline Solution | Placebo comparator | Placebo Receives: Other: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7
Proportion of subjects reaching stabilization or improvement in clinical status in at least one category on a 6-point clinical status scale.
Clinical status categories will be defined as:
- Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief).
- Hospitalization, not requiring supplemental oxygen.
- Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).
- ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥150mmHg.
- ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.
- Death.
Measured: 7 days
Secondary outcomes (6)
Length of Hospital Stay (Time to Discharge)
Median length of hospital stay in subjects treated with Octagam 10%, compared to those that received placebo from randomization through Day 33
Measured: 33 days
Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14
Number of subjects with maintenance or improvement by at least one category on the 6-point clinical status scale on Day 14.
Clinical status categories will be defined as:
- Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief).
- Hospitalization, not requiring supplemental oxygen.
- Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).
- ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥ 150 mmHg.
- ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.
- Death.
Measured: 14 days
Cumulative Duration of Invasive Mechanical Venitlation (IMV)
Duration of invasive mechanical ventilation in subjects treated with Octagam 10% compared to placebo from randomization through Day 33
Measured: 33 days
Number of Subjects With Severe Disease Progression
Number of subjects who experienced severe disease progression while treated with Octagam 10% compared to those that received placebo at Day 33. Severe disease progression is defined as subjects requiring extracorporeal membrane oxygenation, mechanical ventilation and/or died through day 33.
Measured: 33 days
ICU Stay Length
Average length of ICU stay in subjects treated with Octagam 10% compared to those that received placebo from randomization through Day 33.
Measured: 33 days
Cumulative Mortality Rate Through Day 33
Cumulative mortality in subjects treated with Octagam 10% compared to those that received placebo at Day 33
Measured: 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start1 Jun 2020
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
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.
- More trials run by OctapharmaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400058
- Sponsor's protocol ID
- GAM10-10
- Status last verified
- Jan 2024
- First submitted
- 21 May 2020
- Last updated
- 18 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression
- ClinicalTrials.gov ID
- NCT04400058
- Acronym / sponsor ID
- GAM10-10
- Conditions
- Covid-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 22 May 2020 (actual)
- Results
- Posted 18 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, multicenter, Phase 3 study to evaluate if high-dose Octagam 10% therapy can stabilize or improve clinical status in patients with severe Coronavirus disease
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octagam 10% | Experimental | Biological: Octagam 10%Octagam 10% |
| Saline Solution | Placebo comparator | Other: Saline SolutionPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult aged ≥18years old
- Provide voluntary, fully informed written and signed consent before any study-related procedures are conducted
- Able to understand and comply with the relevant aspects of the study protocol
- Laboratory (RT-PCR) confirmed COVID-19 infection on throat swab and/or sputum and/or lower respiratory tract samples
- Hospitalized with a resting room-air SpO2 of ≤93% or PaO2/FiO2 ratio <300mmHg. Measurement can be taken from documented source records in the 24 hours prior to screening
Key exclusion criteria (16 listed)
- Existence of other evidence that can explain pneumonia including but not limited to: Influenza A virus, influenza B virus, bacterial pneumonia (as suggested by the combined clinical picture, radiological findings and known laboratory results [eg, elevated procalcitonin >0.5ng/mL and concomitant neutrophilia]), known fungal pneumonia, suspected fungal pneumonia based on compromised immune system with a history of past fungal infections, noninfectious causes, etc.
- Known history of serious allergic reactions, including anaphylaxis, to IVIG or its preparation components
- Subjects with a history of thromboembolic event (TEE) within the last 12 months, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease (Fontaine IV)
- Subjects with an underlying medical condition that can lead to hypercoagulable states and hyperviscosity such as antithrombin III deficiency, Factor V Leiden, Protein C deficiency, antiphospholipid syndrome and malignancy
- Known history of selective IgA deficiency with antibodies against IgA
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 |
|---|---|---|
| Octagam 10%Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days | Biological | Octagam 10% |
| Saline SolutionPlacebo | Other | Saline Solution |
Primary outcome
Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7
Time frame: 7 days
Proportion of subjects reaching stabilization or improvement in clinical status in at least one category on a 6-point clinical status scale. Clinical status categories will be defined as: 1. Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief). 2. Hospitalization, not requiring supplemental oxygen. 3. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). 4. ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥150mmHg. 5. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. 6. Death.
6 secondary outcomes
Length of Hospital Stay (Time to Discharge)
Time frame: 33 days
Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14
Time frame: 14 days
Cumulative Duration of Invasive Mechanical Venitlation (IMV)
Time frame: 33 days
Number of Subjects With Severe Disease Progression
Time frame: 33 days
ICU Stay Length
Time frame: 33 days
Cumulative Mortality Rate Through Day 33
Time frame: 33 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octagam 10% and Saline Solution in people with Covid-19, run by Octapharma at 22 sites in 3 countries.
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 16 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Russia, Ukraine. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 18 Jan 2024). 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?
Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7 (time frame: 7 days). 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 18 Jan 2024.