H-IVIG Treatment for Severe H1N1 2009

NCT01617317 | Completed DMC

• 1 other identifier: HKU-09-330
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment with hyperimmune intravenous immunoglobulin (H-IVIG), derived from convalescent plasma from patients recovered from H1N1 2009 influenza A infection, for patients with severe H1N1 2009 infection will decrease mortality, reduce viral load, and shorten the length of stay in ICU and hospital.

Conditions

Novel 2009 Influenza A (H1N1) Infection

Keywords

H1N1 2009; hyperimmune IVIG; mortality; length of stay; viral load; cytokine

Outcome Measures

Primary Outcomes (1)

• Mortality

  From date of randomization until the date of death from any cause during hospitalization, assessed up to 6 months

Secondary Outcomes (5)

• Adverse events

  From date of randomization until the date of first documented adverse events due to treatment, assessed up to 1 week

• ICU length of stay

  Participants will be followed for the duration of ICU stay, an expected average of 4 weeks

• Hospital length of stay

  Participants will be followed for the duration of hospital stay, an expected average of 12 weeks

• Nasopharyngeal viral load

  One day before randomization and up to 5 days after treatment

• Cytokine/ chemokine

  One day before randomization and up to 5 days after treatment

Study Arms (2)

Intravenous immunoglobulin

ACTIVE COMPARATOR

Single intravenous infusion of 0.4g/kg of simple IVIG which contain no H1N1 2009 antibody (manufactured before 2009).

Drug: Intravenous immunoglobulin

Hyperimmune intravenous immunoglobulin

EXPERIMENTAL

Single intravenous infusion of 0.4g/kg of H1N1 2009 H-IVIG fractionated from convalescent plasma (H1N1 2009 antibody titer was 1:320 by hemagglutination inhibition and neutralizing antibody assays)

Drug: Hyperimmune intravenous immunoglobulin

Interventions

Hyperimmune intravenous immunoglobulin DRUG

Single intravenous infusion of 0.4g/kg of H1N1 2009 H-IVIG

Also known as: H-IVIG

Hyperimmune intravenous immunoglobulin

Intravenous immunoglobulin DRUG

Single intravenous infusion of 0.4g/kg of simple IVIG

Also known as: IVIG

Intravenous immunoglobulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (fulfill all criteria): male or female patients 18 years or older
• written informed consent by patient or next of kin (if patients too ill)
• diagnosis of H1N1 2009 infection satisfying both clinical and laboratory criteria:
• Laboratory criteria: at least one RT-PCR positive for H1N1 2009 from one of the clinical specimens (NPA, ETA, blood, urine or stool).
• Clinical criteria: patients admitted to ICU with severe community acquired pneumonia as defined by a CURB-65 score of 3 or more
• deterioration during treatment with optimal antiviral (oral or inhaler agents only) and typical and atypical antimicrobial coverage
• required ICU and ventilatory support and within 7 days onset of symptoms.

You may not qualify if:

• age below 18 years
• known hypersensitivity to immune globulin or any components of the formulation
• known IgA deficiency
• acquire the H1N1 2009 infection from health care facility
• moribund patients or refusal of informed consent.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Queen Mary Hospital, Hong Kong: collaborator
• Pamela Youde Nethersole Eastern Hospital: collaborator
• Ruttonjee Hospital, Hong Kong: collaborator
• United Christian Hospital: collaborator
• Queen Elizabeth Hospital, Hong Kong: collaborator
• Caritas Medical Centre, Hong Kong: collaborator
• HK Red Cross Blood Transfusion Service, Hong Kong: collaborator
• Research Fund for the Control of Infectious Diseases, Hong Kong: collaborator

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (8)

• Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.

  PMID: 21248066 BACKGROUND

• Hung IF, To KK, Lee CK, Lin CK, Chan JF, Tse H, Cheng VC, Chen H, Ho PL, Tse CW, Ng TK, Que TL, Chan KH, Yuen KY. Effect of clinical and virological parameters on the level of neutralizing antibody against pandemic influenza A virus H1N1 2009. Clin Infect Dis. 2010 Aug 1;51(3):274-9. doi: 10.1086/653940.

  PMID: 20575664 BACKGROUND

• To KK, Hung IF, Li IW, Lee KL, Koo CK, Yan WW, Liu R, Ho KY, Chu KH, Watt CL, Luk WK, Lai KY, Chow FL, Mok T, Buckley T, Chan JF, Wong SS, Zheng B, Chen H, Lau CC, Tse H, Cheng VC, Chan KH, Yuen KY. Delayed clearance of viral load and marked cytokine activation in severe cases of pandemic H1N1 2009 influenza virus infection. Clin Infect Dis. 2010 Mar 15;50(6):850-9. doi: 10.1086/650581.

  PMID: 20136415 BACKGROUND

• Wu JT, Lee CK, Cowling BJ, Yuen KY. Logistical feasibility and potential benefits of a population-wide passive-immunotherapy program during an influenza pandemic. Proc Natl Acad Sci U S A. 2010 Feb 16;107(7):3269-74. doi: 10.1073/pnas.0911596107. Epub 2010 Feb 1.

  PMID: 20133660 BACKGROUND

• Wong HK, Lee CK, Hung IF, Leung JN, Hong J, Yuen KY, Lin CK. Practical limitations of convalescent plasma collection: a case scenario in pandemic preparation for influenza A (H1N1) infection. Transfusion. 2010 Sep;50(9):1967-71. doi: 10.1111/j.1537-2995.2010.02651.x.

  PMID: 20412524 BACKGROUND

• Zhou B, Zhong N, Guan Y. Treatment with convalescent plasma for influenza A (H5N1) infection. N Engl J Med. 2007 Oct 4;357(14):1450-1. doi: 10.1056/NEJMc070359. No abstract available.

  PMID: 17914053 BACKGROUND

• Luke TC, Kilbane EM, Jackson JL, Hoffman SL. Meta-analysis: convalescent blood products for Spanish influenza pneumonia: a future H5N1 treatment? Ann Intern Med. 2006 Oct 17;145(8):599-609. doi: 10.7326/0003-4819-145-8-200610170-00139. Epub 2006 Aug 29.

  PMID: 16940336 BACKGROUND

• Hung IFN, To KKW, Lee CK, Lee KL, Yan WW, Chan K, Chan WM, Ngai CW, Law KI, Chow FL, Liu R, Lai KY, Lau CCY, Liu SH, Chan KH, Lin CK, Yuen KY. Hyperimmune IV immunoglobulin treatment: a multicenter double-blind randomized controlled trial for patients with severe 2009 influenza A(H1N1) infection. Chest. 2013 Aug;144(2):464-473. doi: 10.1378/chest.12-2907.

  PMID: 23450336 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Immunoglobulins, Intravenous

Intervention Hierarchy (Ancestors)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ivan FN Hung, MD FRCP

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 2, 2012
• First Posted: June 12, 2012
• Study Start: January 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: May 1, 2012
• Last Updated: June 12, 2012

Record last verified: 2012-06

Locations

HK (1)