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Treatment of severe 2009 H1N1 infection with convalescent plasma will reduce mortality.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H1N1 convalescent plasma and oseltamivir | Active Comparator | Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma |
|
| Oral Oseltamivir alone | Active Comparator | Oseltamivir 75mg bid during ICU hospitalization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H1N1 convalescent plasma and oseltamivir | Drug | Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma containing >= 1:160 of neutralizing antibody to Pandemic influenza A H1N1 |
| Measure | Description | Time Frame |
|---|---|---|
| Death | mortality during hospitalization directly related to H1N1 2009 infection | Participants are followed until death or discharge from ICU (average 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Complication | including pneumonia, ARDS, renal failure, heart failure and secondary infection | Participants are followed until death or discharge from ICU (average 2 weeks) |
| Length of stay in ICU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivan FN HUNG, MD FRCP | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Hong Kong, Queen Mary Hospital | Hong Kong SAR | China |
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| ID | Term |
|---|---|
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Oral Oseltamivir alone | Drug | Oral Oseltamivir 75mg bid during ICU hospitalization |
|
days of stay in ICU
| 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 | Participants are followed until death or discharge from ICU (average 2 weeks) |
| Time on respiratory support | including ventilator, CPAP and BiPAP | Participants are followed until death or discharge from ICU (average 2 weeks) |
| Change in viral load | Daily measurement of H1N1 2009 viral load | Participants are followed until death or discharge from ICU (average 2 weeks) |
| Change in cytokine level | daily measurement of cytokine level (serum) | Participants are followed until death or discharge from ICU (average 2 weeks) |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |