Covid19Phase 4NCT04616001
IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation
A Phase 4 study testing IVIG in people with Covid19 and SARS-CoV Infection, run by Sharp HealthCare at 1 site in United States.
Trial summary
The purpose of this Pilot Study is to establish a hypothesis of whether or not intravenous immunoglobulin (IVIG) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with SARS-CoV-2 virus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, SARS-CoV Infection
- What is being tested?
- IVIG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 30 Jun 2021
- Phase
- Phase 4
- 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
- Confirmed COVID-19 positive test result
- Initiation of the first dose of IVIG within 72 hours of mechanical ventilation.
- Age >18 years old.
- Consenting next of kin having access to an electronic device that is able to access DocuSign® online and email for consenting.
- Subjects or their proxy must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
Who cannot join
- Superimposed bacterial pneumonia or bacteremia
- Severe allergy to any IVIG product formulation
- Hypersensitivity to corn
- Uncontrolled hypertension (SBP>180 mm Hg or DBP>120mmHg)
- Active participant in another research treatment study
- Advanced dementia
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- Severe renal disease (CrCl< 20 mL/min)
- Active cancer malignancy
- Active treatment with cancer chemotherapy or immunotherapy
- Congestive heart failure clinically or by history (EF< 25%)
- Prior receipt during admission of any other investigational agent (eg. convalescent plasma, tocilizumab)
- Venous or arterial thrombosis < 90 days prior
- Are receiving cytotoxic or biologic treatments such as TNF inhibitors, anti-interleukin-1 (IL-1), anti-IL-6 (tocilizumab or sarilumab), T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. Note: A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening, with the following exceptions:
- B-cell targeted therapies: a washout period of 24 weeks or 5 half-lives (whichever is longer)
- TNF inhibitors: a washout period of 2 weeks or 5 half-lives (whichever is longer), and
- JAK inhibitor: a washout period of 1 week or 5 half-lives (whichever is longer).
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Memorial Hospital
San Diego, California, 92123
Kathryn Miller, 858-939-7161, kathryn.miller@sharp.com
About this study
Official title: Pilot Study of the Use of IVIG in Patients With Severe COVID-19 Infections Requiring Mechanical Ventilation and to Assess Their Biological Responses to IVIG Therapy
The purpose of this Pilot Study is to establish a hypothesis of whether or not intravenous immunoglobulin (IVIG) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with SARS-CoV-2 virus.
Read the detailed description
This is an investigator initiated, open label, 1 arm study to observe the impact of length of hospitalization by starting IVIG administration within 48 hours of mechanical ventilation. The exploratory objective is to analyze the blood before, during and after IVIG administration. The blood will be analyzed for the production of inflammatory and non-inflammatory cytokines, biomarkers for endothelial injury and biomarkers for coagulation via Mass Spectrometry.
- Conditions
- Covid19, SARS-CoV Infection
- Being tested
- IVIG
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIGDrug
Also called Octagam
Patients will receive IVIG daily for four days.
| Study group | Role | What they receive |
|---|---|---|
| IVIG | Experimental | IVIG 0.5gram/kg IVPB using actual body weight daily x 4 days Receives: Drug: IVIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
Assess hospital length of stay after mechanical ventilation
Measured: Up to 60 days
Secondary outcomes (1)
Human metabolome and proteome
Analyze the blood to assess the human metabolome and proteome in patients with COVID-19 receiving IVIG including production of inflammatory and anti-inflammatory cytokines, markers of endothelial injury, and coagulation using Mass Spectrometry
Measured: 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 posted4 Nov 2020
- Study start1 Nov 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single group, pilot study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Sakoulas, MD, Sharp HealthCare
- Investigators
- George Sakoulas, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616001
- Sponsor's protocol ID
- COVID-IVIG VENT
- Other IDs
- 2010902
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- 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 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Use of IVIG in Patients With Severe COVID-19 Infections Requiring Mechanical Ventilation and to Assess Their Biological Responses to IVIG Therapy
- ClinicalTrials.gov ID
- NCT04616001
- Acronym / sponsor ID
- COVID-IVIG VENT
- Conditions
- Covid19, SARS-CoV Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 4 Nov 2020 (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 Pilot Study is to establish a hypothesis of whether or not intravenous immunoglobulin (IVIG) may impact the hospital length of stay, if started within 48 of mechanical ventilation in patients infected with SARS-CoV-2 virus.
Detailed description
This is an investigator initiated, open label, 1 arm study to observe the impact of length of hospitalization by starting IVIG administration within 48 hours of mechanical ventilation. The exploratory objective is to analyze the blood before, during and after IVIG administration. The blood will be analyzed for the production of inflammatory and non-inflammatory cytokines, biomarkers for endothelial injury and biomarkers for coagulation via Mass Spectrometry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single group, pilot study
| Arm | Type | Receives |
|---|---|---|
| IVIG | Experimental | Drug: IVIGIVIG 0.5gram/kg IVPB using actual body weight daily x 4 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed COVID-19 positive test result
- Initiation of the first dose of IVIG within 72 hours of mechanical ventilation.
- Age >18 years old.
- Consenting next of kin having access to an electronic device that is able to access DocuSign® online and email for consenting.
- Subjects or their proxy must have the ability to understand the requirements of the study, provide informed consent, and provide authorization of use and disclosure of personal health information.
Key exclusion criteria (16 listed)
- Superimposed bacterial pneumonia or bacteremia
- Severe allergy to any IVIG product formulation
- Hypersensitivity to 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 |
|---|---|---|
| IVIGAlso: OctagamPatients will receive IVIG daily for four days. | Drug | IVIG |
Primary outcome
Hospital length of stay
Time frame: Up to 60 days
Assess hospital length of stay after mechanical ventilation
1 secondary outcome
Human metabolome and proteome
Time frame: Up to 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IVIG in people with Covid19 and SARS-CoV Infection, run by Sharp HealthCare 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 5 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: status not confirmed, as of the sponsor's last update on 4 Nov 2020. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Miller (858-939-7161, kathryn.miller@sharp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: Up to 60 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 4 Nov 2020.