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Assessment of Efficacy of CR8020 and CR6261, Monoclonal Antibodies, Against Influenza Infection

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ClinicalTrials.gov Identifier: NCT01992276
Recruitment Status : Withdrawn (Due to preliminary efficacy results from an influenza challenge trial)
First Posted : November 25, 2013
Last Update Posted : March 4, 2014
Sponsor:
Collaborators:
Division of Microbiology and Infectious Diseases (DMID)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Crucell Holland BV

Brief Summary:
The purpose of this study is to evaluate the rate of decline in quantitative viral load measured in hospitalized patients with Influenza A infection

Condition or disease Intervention/treatment Phase
Influenza Biological: CR8020 Biological: CR6261 Biological: Placebo Phase 2

Detailed Description:
This is a randomized, placebo-controlled, double-blind phase IIa proof-of-concept study, designed to evaluate the effect of CR8020, CR6261, or placebo in hospitalized patients with influenza A infection that are receiving standard of care. Up to 262 participants will be randomized to receive 30 mg/kg of CR8020, 30 mg/kg of CR6261, or placebo. The study duration will be approximately 117 days for each participant. Prior to enrollment, participants will be screened to assess their eligibility. Eligible participants will be randomized to CR8020, CR6261, or placebo and study drug will be administered on Day 1. Participants will be followed up for 115 days in 9 visits on Days 2 to 8, Day 29, and Day 116 (end of study). After hospital discharge, the remaining follow-up visits will be performed as outpatient visits.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of CR8020 and CR6261 in Hospitalized Patients With Influenza A Infection
Study Start Date : December 2013
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: CR8020
Investigational monoclonal antibody against influenza A viruses
Biological: CR8020
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
Other Name: CR8020 30 mg/kg by iv infusion

Experimental: CR6261
Investigational monoclonal antibody against influenza A viruses
Biological: CR6261
30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
Other Name: CR6261 30 mg/kg by iv infusion

Placebo Comparator: Placebo
Dextrose: 5% in water
Biological: Placebo
Administered as a single 2-hour intravenous infusion on Day 1
Other Name: Placebo by iv infusion




Primary Outcome Measures :
  1. Rate of decline in quantitative viral load [ Time Frame: Baseline to Day 8 ]

Secondary Outcome Measures :
  1. Clinical improvement [ Time Frame: Baseline to Day 15 ]

    Daily influenza symptoms and signs:

    Four domains from the Influenza Intensity and Impact Questionnaire will be evaluated (scored 0-3: none, mild, moderate, severe):

    -Influenza symptoms (respiratory and systemic domains Impact on daily activities Impact on emotions Impact on others


  2. Rate of decline in quantitative viral load (subjects not intubated at baseline) [ Time Frame: Baseline to Day 8 ]
  3. Rate of decline in quantitative viral load (subjects intubated at baseline) [ Time Frame: Baseline to Day 8 ]
  4. Rate of decline in quantitative viral load [ Time Frame: Baseline to Day 8 ]
  5. Incidence of adverse events [ Time Frame: Baseline to Day 116 ]
  6. Incidence of serious adverse events [ Time Frame: Baseline to Day 116 ]
  7. Area under the curve of viral load [ Time Frame: Baseline to Day 8 ]
  8. Clinical course for ICU patients [ Time Frame: Baseline to Day 8 ]
  9. Length of hospital stay [ Time Frame: The duration of hospital stay, an expected average of 7 days ]
  10. Survival times [ Time Frame: Baseline to Day 116 ]
    Survival times measured from randomization to time of death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Participant requires hospitalization/ Each participant or his or her legally acceptable representative must sign an informed consent form/ Participant must be able to start the infusion within 36 hours from the time the screening specimen was collected/ A woman must either be not of childbearing potential or of childbearing potential and agrees to practice two forms of highly effective method of birth control/ A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [beta hCG]) at screening/ A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control/

Exclusion Criteria:

Participant is a female who is pregnant or breastfeeding/ Participant undergoing peritoneal dialysis, hemodialysis or hemofiltration/ Participant has presence of any pre-existing illness that, in the opinion of the investigator, would place the participant at an unreasonably increased risk through participation in this study/ Participant has prior treatment with an experimental mAb; or receipt of IgG within 3 months or on chronic mAb treatment prior to enrollment/ Participant has known or suspected hypersensitivity to any of the CR8020 or CR6261 excipients (sucrose, L-histidine L-histidine monohydrochloride, polysorbate 20)/ Participant received an investigational product (including investigational vaccines) or used an investigational medical device within 60 days before the planned start of treatment, is currently enrolled in an interventional investigational study, or is an employee of the investigational site/


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992276


Locations
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Sponsors and Collaborators
Crucell Holland BV
Division of Microbiology and Infectious Diseases (DMID)
National Institutes of Health (NIH)
Investigators
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Study Director: Crucell Holland BV Clinical Trial Crucell Holland BV
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Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01992276    
Other Study ID Numbers: CR102576
2013-003341-41 ( EudraCT Number )
CR6261CR8020FLZ2001 ( Other Identifier: Crucell Holland BV )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014
Keywords provided by Crucell Holland BV:
Influenza
Virus
Monoclonal Antibody
Immunization
Treatment
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases