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Trial record 19 of 20 for:    Liberia

Putative Investigational Therapeutics in the Treatment of Patients With Known Ebola Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02363322
Recruitment Status : Completed
First Posted : February 16, 2015
Results First Posted : May 14, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborators:
The Ministry of Health and Social Welfare, Liberia
The Ministry of Health and Sanitation, Sierra Leone
Institut National de la Santé Et de la Recherche Médicale, France
The Ministry of Health and Public Hygiene, Guinea
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ebola Virus Infection
Interventions Drug: B/Current Standard of Care Plus ZMapp
Other: A/Current Standard of Care Alone
Enrollment 72
Recruitment Details Beginnning in March 2015 through November 2015 a total of 72 patients were enrolled at sites in Liberia, Sierra Leone, Guinea, and the United States.
Pre-assignment Details  
Arm/Group Title A/Current Standard of Care Alone B/Current Standard of Care Plus ZMapp
Hide Arm/Group Description

Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting

Treatment A: Optimized standard of care for Ebola virus infection

ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting.

ZMApp: Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus

Period Title: Overall Study
Started 36 36
Completed 35 36
Not Completed 1 0
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title A/Current Standard of Care Alone B/Current Standard of Care Plus ZMapp Total
Hide Arm/Group Description Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting

ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting.

ZMApp: Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus

Total of all reporting groups
Overall Number of Baseline Participants 36 36 72
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 36 participants 72 participants
27.9  (16.4) 24.3  (18.3) 26.1  (17.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Female
17
  47.2%
23
  63.9%
40
  55.6%
Male
19
  52.8%
13
  36.1%
32
  44.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
31
  86.1%
29
  80.6%
60
  83.3%
White
1
   2.8%
0
   0.0%
1
   1.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  11.1%
7
  19.4%
11
  15.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 36 participants 72 participants
Liberia 2 3 5
United States 1 0 1
Guinea 5 7 12
Sierra Leone 28 26 54
1.Primary Outcome
Title Mortality
Hide Description Death at Day 28
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Seven of the eight deaths recorded in ZMapp recipients occurred before day 4, before the second of three planned infusions of ZMapp. The exception was one patient who received a second infusion on day 4 and died later that day. In the group that received the current standard of care alone, all 13 deaths occurred during the first 8 days of follow-up
Arm/Group Title A/Current Standard of Care Alone B/Current Standard of Care Plus ZMapp
Hide Arm/Group Description:
Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting

ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting.

ZMApp: Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus

Overall Number of Participants Analyzed 35 36
Measure Type: Count of Participants
Unit of Measure: Participants
13
  37.1%
8
  22.2%
2.Secondary Outcome
Title Number of Participants With ZMapp Infusion-related Adverse Events
Hide Description Adverse events related to ZMapp infusions
Time Frame 10 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Arm A Received the Current Standard of Care Alone and not the ZMapp infusion
Arm/Group Title A/Current Standard of Care Alone B/Current Standard of Care Plus ZMapp
Hide Arm/Group Description:
Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting

ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting.

ZMApp: Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus

Overall Number of Participants Analyzed 0 36
Measure Type: Number
Unit of Measure: participants
Hypotension 7
Elevation in fever 8
Tachycardia 4
Tachypnea 3
Hypertension 3
Confusion 2
Seizure 1
Difficulty Breathing 1
Chills 1
Vomiting 1
Agitation 1
3.Secondary Outcome
Title Plasma Viral Load
Hide Description Time to viral clearance
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A/Current Standard of Care Alone B/Current Standard of Care Plus ZMapp
Hide Arm/Group Description:
Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting

ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting.

ZMApp: Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus

Overall Number of Participants Analyzed 35 36
Median (Full Range)
Unit of Measure: days
13
(0 to 28)
9
(0 to 28)
Time Frame 8 months, from March 2015 through November 2015
Adverse Event Reporting Description Only Serious Adverse Events and Infusion related events were recorded.
 
Arm/Group Title A/Current Standard of Care Alone B/Current Standard of Care Plus ZMapp
Hide Arm/Group Description Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting

ZMapp (Trademark) + Optimized standard of care to include aggressive fluid resuscitation, hemodynamic support, and other interventions available in an optimized care setting.

ZMApp: Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus

All-Cause Mortality
A/Current Standard of Care Alone B/Current Standard of Care Plus ZMapp
Affected / at Risk (%) Affected / at Risk (%)
Total   13/35 (37.14%)      8/36 (22.22%)    
Show Serious Adverse Events Hide Serious Adverse Events
A/Current Standard of Care Alone B/Current Standard of Care Plus ZMapp
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/35 (37.14%)      11/36 (30.56%)    
Gastrointestinal disorders     
Severe diarrhea *  0/35 (0.00%)  0 1/36 (2.78%)  1
Infections and infestations     
Death due to EVD *  10/35 (28.57%)  10 2/36 (5.56%)  2
Multi-organ failure due to EVD *  2/35 (5.71%)  2 3/36 (8.33%)  3
Death due to sepsis *  0/35 (0.00%)  0 1/36 (2.78%)  1
Hospitalization with febrile illness (malaria) *  0/35 (0.00%)  0 1/36 (2.78%)  1
Nervous system disorders     
Syncope *  1/35 (2.86%)  1 0/36 (0.00%)  0
Head Injury *  1/35 (2.86%)  1 0/36 (0.00%)  0
Generalized seizure *  0/35 (0.00%)  0 1/36 (2.78%)  1
Renal and urinary disorders     
Worsened renal insufficiency *  1/35 (2.86%)  1 0/36 (0.00%)  0
Vascular disorders     
Death due to Hypotensive Shock *  1/35 (2.86%)  1 0/36 (0.00%)  0
Hypovolemic shock due to acute hemorrhage *  0/35 (0.00%)  0 1/36 (2.78%)  1
Arterial Hypertension *  0/35 (0.00%)  0 1/36 (2.78%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A/Current Standard of Care Alone B/Current Standard of Care Plus ZMapp
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      32/36 (88.89%)    
Gastrointestinal disorders     
Vomiting *  /35  1/36 (2.78%)  1
Infections and infestations     
Elevation in Fever *  /35  8/36 (22.22%)  8
Chills *  /35  1/36 (2.78%)  1
Nervous system disorders     
Confusion *  /35  2/36 (5.56%)  2
Seizure *  /35  1/36 (2.78%)  1
Agitation *  /35  1/36 (2.78%)  1
Respiratory, thoracic and mediastinal disorders     
Tachypnea *  /35  3/36 (8.33%)  3
Difficulty Breathing *  /35  1/36 (2.78%)  1
Vascular disorders     
Hypotension *  /35  7/36 (19.44%)  7
Tachycardia *  /35  4/36 (11.11%)  4
Hypertension *  /35  3/36 (8.33%)  3
*
Indicates events were collected by non-systematic assessment
Due to the severity of the underlying illness (Ebola infection) only infusion-related adverse events were captured.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Richard T. Davey, Jr.
Organization: NIAID/LIR
Phone: 301-496-8029
EMail: rdavey@niaid.nih.gov
Layout table for additonal information
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT02363322     History of Changes
Other Study ID Numbers: 150083
15-I-0083 ( Other Identifier: NIH Office of Protocol Services )
First Submitted: February 13, 2015
First Posted: February 16, 2015
Results First Submitted: August 7, 2018
Results First Posted: May 14, 2019
Last Update Posted: June 5, 2019