Sars-CoV2Phase 4NCT04411667
Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19
A Phase 4 study testing Octagam in people with Sars-CoV2, run by George Sakoulas, MD at 2 sites in United States.
Trial summary
The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized IVIG for patients infected with the influenza virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2
- What is being tested?
- Octagam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Apr 2020to 23 Jun 2020
- Phase
- Phase 4
- 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
- Confirmed COVID-19 positive test result (including presumptive positive).
- Hospitalization
- Requiring ≥4 liters/min O2 nasal cannula to maintain oxygen saturation ≥ 92%, but not mechanically ventilated
- Age ≥18 years old.
- Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.
- Able to read/write/speak English or Spanish fluently.
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- Subjects must have the capacity to provide consent or an appropriate Legally Authorized Representative (LAR) to provide informed consent.
- provide informed consent, and provide authorization of use and disclosure of personal health information.
- Negative pregnancy test for women of childbearing potential.
Who cannot join
- Severe allergy to any IVIG product formulation
- History of DVT, PE, thromboembolic stroke or other thrombotic events
- Hypersensitivity to corn. Octagam® contains maltose which is a sugar derived from corn.
- Uncontrolled hypertension (SBP>180 mm Hg or DBP>120mmHg)
- Active participant in another research treatment study
- Mechanically ventilated patient
- Code status is Do Not Resuscitate or Do Not Intubate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sharp Grossmont Hospital
La Mesa, California, 91942
Sharp Memorial Hospital
San Diego, California, 92123
About this study
Official title: Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection
The purpose of this research is to see if Intravenous Immunoglobulin (IVIG) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized IVIG for patients infected with the influenza virus. The investigator wants to find out if IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune system some help to clear the infection naturally.
Read the detailed description
This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding IVIG to the Standard of Care (SOC) to the SOC without IVIG. Randomization will be 1:1. The goal of this study is to identify whether or not IVIG can halt the progression to respiratory failure requiring mechanical ventilation in subjects admitted to the hospital with confirmed COVID-19. The addition of IVIG to the standard of care treatment for these patients may be beneficial in abating acute lung injury in subjects with SARSCoV-2 induced hypoxia that results in organ injury.
- Conditions
- Sars-CoV2
- Being tested
- Octagam
- Keywords
- Coronavirus, IVIG, COVID-19
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctagamDrug
Also called IVIG
Standard of Care plus Octagam infusion for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Group A (study drug+SOC) | Experimental | Standard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated. Receives: Drug: Octagam |
| Group B (SOC) | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Ventilation
Number of subjects requiring mechanical ventilation due to respiratory failure
Measured: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Secondary outcomes (2)
Oxygen Therapy
Number of days requiring oxygen therapy
Measured: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Length of Stay
Number of days in hospital
Measured: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start28 Apr 2020
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
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 Sars-CoV2Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Sakoulas, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Octapharma
- Responsible party
- Sponsor-investigator, George Sakoulas, MD, Sharp HealthCare
- Investigators
- George Sakoulas, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411667
- Sponsor's protocol ID
- COVID-IVIG
- Other IDs
- 2004902
- Status last verified
- Jun 2021
- First submitted
- 29 May 2020
- Last updated
- 25 Jun 2021
- 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 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04411667
- Acronym / sponsor ID
- COVID-IVIG
- Conditions
- Sars-CoV2
- Keywords
- Coronavirus, IVIG, COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- George Sakoulas, MDUniversity, hospital or other
- Collaborators
- Octapharma
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Posted 25 Jun 2021
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 research is to see if Intravenous Immunoglobulin (IVIG) can help reduce respiratory complications (respiratory failure and need for a ventilator) caused by coronavirus disease 2019 (COVID-19). The principal investigator has successfully utilized IVIG for patients infected with the influenza virus. The investigator wants to find out if IVIG is equally effective in COVID-19 infection patients, and if IVIG will give the immune system some help to clear the infection naturally.
Detailed description
This is an investigator initiated, open label, multicenter, two arm, randomized study to compare the impact of adding IVIG to the Standard of Care (SOC) to the SOC without IVIG. Randomization will be 1:1. The goal of this study is to identify whether or not IVIG can halt the progression to respiratory failure requiring mechanical ventilation in subjects admitted to the hospital with confirmed COVID-19. The addition of IVIG to the standard of care treatment for these patients may be beneficial in abating acute lung injury in subjects with SARSCoV-2 induced hypoxia that results in organ injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized into one of two groups: Standard of Care plus IVIG or Standard of Care.
| Arm | Type | Receives |
|---|---|---|
| Group A (study drug+SOC) | Experimental | Drug: OctagamStandard of care plus IVIG (Octagam) 0.5g/kg IVPB actual body weight daily x 3 days, with premedication methylprednisolone 40 mg IV push x 1 30-50 minutes before each IVIG infusion. Initial infusion rate of IVIG (Octagam) will be of 0.6 mL/kg/hour, increasing to a maximum rate of 100ml/hr, if tolerated. |
| Group B (SOC) | No intervention | –Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed COVID-19 positive test result (including presumptive positive).
- Hospitalization
- Requiring ≥4 liters/min O2 nasal cannula to maintain oxygen saturation ≥ 92%, but not mechanically ventilated
- Age ≥18 years old.
- Access to a phone in the hospital room or an electronic device that is capable of receiving phone calls and/or video calls and/or e-mail.
Key exclusion criteria (7 listed)
- Severe allergy to any IVIG product formulation
- History of DVT, PE, thromboembolic stroke or other thrombotic events
- Hypersensitivity to corn. Octagam® contains maltose which is a sugar derived from corn.
- Uncontrolled hypertension (SBP>180 mm Hg or DBP>120mmHg)
- Active participant in another research treatment study
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 |
|---|---|---|
| OctagamAlso: IVIGStandard of Care plus Octagam infusion for 3 days. | Drug | Group A (study drug+SOC) |
Primary outcome
Mechanical Ventilation
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Number of subjects requiring mechanical ventilation due to respiratory failure
2 secondary outcomes
Oxygen Therapy
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 days
Length of Stay
Time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- 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.
George Sakoulas, MD principal investigator
Sharp HealthCare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Octagam in people with Sars-CoV2, run by George Sakoulas, MD at 2 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 9 inclusion and 7 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 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 25 Jun 2021). 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?
Mechanical Ventilation (time frame: from date of patient admission to date of patient discharge or date of death, whichever came first, assessed up to 45 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 25 Jun 2021.