Influenza ANCT01306773
Convalescent Plasma Treatment in Severe 2009 H1N1 Infection
A study testing H1N1 convalescent plasma and oseltamivir and Oral Oseltamivir alone in people with Influenza A, run by The University of Hong Kong at 1 site in China.
Trial summary
Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza A
- What is being tested?
- H1N1 convalescent plasma and oseltamivir and Oral Oseltamivir alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Dec 2010
- Phase
- Interventional
- 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
- adult patients ≥ 18 years old with written informed consent given by patient or next-of-kin
- laboratory confirmatory diagnosis of 2009 H1N1 infection by positive RT-PCR from respiratory specimens
- required intensive care within 7 days of onset of symptoms
Who cannot join
- age 18 years old or below
- known hypersensitivity to immune globulin
- known IgA deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Convalescent Plasma Treatment in Patients With Severe 2009 H1N1 Infection: a Prospective Cohort Study
Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.
Read the detailed description
Patients presented with severe 2009 H1N1 infection responded poorly to antiviral agents. Meta-analysis of reports from 1918 H1N1 pandemic suggested that convalescent plasma might be an effective treatment option for patients with severe 2009 H1N1 infection.
- Conditions
- Influenza A
- Being tested
- H1N1 convalescent plasma and oseltamivir, Oral Oseltamivir alone
- Keywords
- Influenza A, convalescent plasma, death
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H1N1 convalescent plasma and oseltamivirDrug
Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma containing >= 1:160 of neutralizing antibody to Pandemic influenza A H1N1
Oral Oseltamivir aloneDrug
Oral Oseltamivir 75mg bid during ICU hospitalization
| Study group | Role | What they receive |
|---|---|---|
| H1N1 convalescent plasma and oseltamivir | Active comparator | Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma Receives: Drug: H1N1 convalescent plasma and oseltamivir |
| Oral Oseltamivir alone | Active comparator | Oseltamivir 75mg bid during ICU hospitalization Receives: Drug: Oral Oseltamivir alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
mortality during hospitalization directly related to H1N1 2009 infection
Measured: Participants are followed until death or discharge from ICU (average 2 weeks)
Secondary outcomes (6)
Complication
including pneumonia, ARDS, renal failure, heart failure and secondary infection
Measured: Participants are followed until death or discharge from ICU (average 2 weeks)
Length of stay in ICU
days of stay in ICU
Measured: Participants are followed until death or discharge from ICU (average 2 weeks)
Adverse events secondary to the convalescent plasma treatment
Allergic reaction (including anaphylaxis), acute renal failure, fluid overload
Measured: Participants are followed until death or discharge from ICU (average 2 weeks)
Time on respiratory support
including ventilator, CPAP and BiPAP
Measured: Participants are followed until death or discharge from ICU (average 2 weeks)
Change in viral load
Daily measurement of H1N1 2009 viral load
Measured: Participants are followed until death or discharge from ICU (average 2 weeks)
Change in cytokine level
daily measurement of cytokine level (serum)
Measured: Participants are followed until death or discharge from ICU (average 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza AStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Ivan FN HUNG, MD FRCP, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306773
- Sponsor's protocol ID
- HKU-CP1
- Status last verified
- Mar 2011
- First submitted
- 5 Jan 2011
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma Treatment in Patients With Severe 2009 H1N1 Infection: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01306773
- Acronym / sponsor ID
- HKU-CP1
- Conditions
- Influenza A
- Keywords
- Influenza A, convalescent plasma, death
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 2 Mar 2011 (estimated)
- 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.
Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.
Detailed description
Patients presented with severe 2009 H1N1 infection responded poorly to antiviral agents. Meta-analysis of reports from 1918 H1N1 pandemic suggested that convalescent plasma might be an effective treatment option for patients with severe 2009 H1N1 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| H1N1 convalescent plasma and oseltamivir | Active comparator | Drug: H1N1 convalescent plasma and oseltamivirOseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma |
| Oral Oseltamivir alone | Active comparator | Drug: Oral Oseltamivir aloneOseltamivir 75mg bid during ICU hospitalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients ≥ 18 years old with written informed consent given by patient or next-of-kin
- laboratory confirmatory diagnosis of 2009 H1N1 infection by positive RT-PCR from respiratory specimens
- required intensive care within 7 days of onset of symptoms
Key exclusion criteria (3 listed)
- age 18 years old or below
- known hypersensitivity to immune globulin
- known IgA deficiency
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 |
|---|---|---|
| H1N1 convalescent plasma and oseltamivirOseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma containing >= 1:160 of neutralizing antibody to Pandemic influenza A H1N1 | Drug | H1N1 convalescent plasma and oseltamivir |
| Oral Oseltamivir aloneOral Oseltamivir 75mg bid during ICU hospitalization | Drug | Oral Oseltamivir alone |
Primary outcome
Death
Time frame: Participants are followed until death or discharge from ICU (average 2 weeks)
mortality during hospitalization directly related to H1N1 2009 infection
6 secondary outcomes
Complication
Time frame: Participants are followed until death or discharge from ICU (average 2 weeks)
Length of stay in ICU
Time frame: Participants are followed until death or discharge from ICU (average 2 weeks)
Adverse events secondary to the convalescent plasma treatment
Time frame: Participants are followed until death or discharge from ICU (average 2 weeks)
Time on respiratory support
Time frame: Participants are followed until death or discharge from ICU (average 2 weeks)
Change in viral load
Time frame: Participants are followed until death or discharge from ICU (average 2 weeks)
Change in cytokine level
Time frame: Participants are followed until death or discharge from ICU (average 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
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Healthy Participants
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.
Ivan FN HUNG, MD FRCP principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H1N1 convalescent plasma and oseltamivir and Oral Oseltamivir alone in people with Influenza A, run by The University of Hong Kong at 1 site in China.
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 3 inclusion and 3 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 2 Mar 2011. 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 China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Death (time frame: Participants are followed until death or discharge from ICU (average 2 weeks)). 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 2 Mar 2011.