Ebola-Tx: Emergency Evaluation of Convalescent Plasma for Ebola Viral Disease (EVD) in Guinea
Study Details
Study Description
Brief Summary
This is an emergency, phase 2/3, open-label, non-randomized, clinical trial that will evaluate Convalescent Plasma (CP) added to standardized supportive care (SC) in patients with confirmed Ebola Virus Disease (EVD). No patient will be refused CP when compatible products are available and all efforts will be made to maximize CP availability during the study. EVD patients recruited during the period before CP becomes available or for whom no compatible CP is available will be given SC and will be followed for study outcomes. Data from these SC patients will be the used as comparator in the analysis of the study. The primary objective of the study is to assess if CP + SC improves the 14 day survival of patients, compared to SC alone.
The Investigators aim to enroll a total number of 130 - 200 patients who will be treated treated with CP assuming equal numbers of patients treated with SC alone. If there would be insufficient patients treated with SC, patients treated at the research site prior to study start may be included in the comparison group.
Patients will be recruited in the Ebola Treatment centre managed by Medecins Sans Frontieres (MSF) in Conakry, Guinea. All patients and/or relatives presenting at the centre will be informed about the study, and will be invited to provide consent at the time of admission inside the treatment centre. Only patients for whom ebola infection is confirmed with polymerase chain reaction (PCR) will be enrolled in the study. After inclusion, eligibility to the intervention will be reassessed on regular intervals. If the eligibility criteria are not met by 48 hours after inclusion, only SC will be continued.
In line with the guidance of the World Health Organization (WHO), two units of CP will be given. EVD patients will be transfused with ABO-compatible CP using standard procedures. Details on the modalities of transfusion can be found in the WHO guidance document and the MSF guidelines on blood transfusion. All patients will be under close observation for transfusion-related adverse reactions during and up to 4 hours after transfusion. 24 hours after the start of transfusion, a blood sample will be collected for viral load assessment. All other aspects of patient management will be according to MSF clinical guidelines. The decision to discharge a patient should be taken on clinical grounds, but can be supported by the laboratory results. After discharge, the patient will be followed up by the study team until day 30.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
West-Africa is being ravaged by the worst outbreak of Ebola Viral Disease (EVD) ever witnessed. Nine months after its onset, the outbreak has spiraled and currently appears to be out of control. One of the key factors contributing to the high mortality is the lack of any proven effective EVD specific treatment. The identification of effective therapies is a medical and public health priority. Convalescent whole blood (CWB) and convalescent plasma (CP) have been prioritized by the World Health Organization (WHO) to be evaluated within a short time span, so that widespread use for therapy could be implemented rapidly if proven effective. Both CWB and CP contain EBV antibodies and either could potentially be of value as EVD therapy, however their efficacy in Ebola must still be demonstrated. .
This is an emergency, phase 2/3, open-label, non-randomized, clinical trial that will evaluate CP added to standardized supportive care (SC) in patients with confirmed EVD. No patient will be refused CP when compatible products are available and all efforts will be made to maximize CP availability during the study. EVD patients recruited during the period before CP becomes available or for whom no compatible CP is available will be given SC and will be followed for study outcomes. Data from these SC patients will be the used as comparator in the analysis of the study.
The primary objective of the study is to assess if CP + SC improves the 14 day survival of patients, compared to SC alone. Secondary objectives are;
-
to assess 30 day survival on CP + SC
-
to assess the relationship between EV antibody levels in donated CP and survival in patients receiving CP
-
to assess the relationship between EV antibody levels in donated CP and changes in levels of viral RNA in the blood of patients receiving CP
-
to assess the occurrence of serious adverse reactions (SARs) related to CP transfusion in Ebola patients
-
to assess the occurrence of safety risks related to CP transfusion in health workers administering the treatments
-
to determine risk factors for mortality despite administration of CP (for identification of patients most likely to benefit)
The Investigators aim to enroll a total number of 130 - 200 patients treated with CP assuming equal numbers of patients treated with SC alone. The number of patients treated with SC will be determined by the time interval for CP to become available for treatment and the availability of CP throughout the study. If there would be insufficient patients treated with SC, patients treated at the research site prior to study start may be included in the comparison group.
Patients will be recruited in the Ebola Treatment centre managed by Medecins Sans Frontieres (MSF) in Conakry. All patients and/or relatives presenting at the centre will be informed about the study, and will be invited to provide consent at the time of admission inside the treatment centre. Only patients for whom ebola infection is confirmed via polymerase chain reaction (PCR) will be enrolled in the study. After inclusion, eligibility to the intervention will be assessed at the time of enrollment (when the patient is moved to the area for patients with confirmed Ebola) and will be reassessed on regular intervals as long as the patient did not receive plasma transfusion. The re-assessment of eligibility to receive CP happens at 8h and at 12h, and is repeated until 48 hours after inclusion. If the eligibility criteria are not met by 48 hours after inclusion, only SC will be continued.
A patient is not eligible to receive CP if they meet one of the following criteria:
-
History of allergic reaction to blood or plasma products (as judged by the investigator or treating physician); (this first criterion is definite and will not be re-assessed)
-
Medical conditions in which receipt of additional fluid related to the transfusion (250-500 ml or in the case of children 10 ml/kg) may be detrimental to the patient (e.g. decompensated congestive heart failure or renal failure).
-
Patients in shock unresponsive to fluid challenge
-
Patients in shock with signs of multi-organ failure, defined as oliguria/anuria AND impaired consciousness AND/OR jaundice
-
Condition of patient where the procedure of plasma administration carries a risk for the staff
In line with the WHO guidance, two units of CP will be given. EVD patients will be transfused with ABO-compatible CP using standard procedures. Details on the modalities of transfusion can be found in the WHO guidance document and the MSF guidelines on blood transfusion. All patients will be under close observation for transfusion-related adverse reactions during and up to 4 hours after transfusion. 24 hours after the start of transfusion, a blood sample will be collected for viral load assessment. All other aspects of patient management will be according to MSF clinical guidelines.
The decision to discharge a patient should be taken on clinical grounds, but can be supported by the laboratory results. After discharge, the patient will be followed up by the study team until day 30.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Convalescent Plasma Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg |
Other: Convalescent Plasma
Patients will be treated with plasma from recovered EVD patients.
|
| No Intervention: standard care The control arm will consist of historical controls having being treated with standard of care |
Outcome Measures
Primary Outcome Measures
- Survival at Day 14 After Start of Intervention [14 days]
Effect of convalescent plasma in improving patients survival at day 14; it will be considered clinically significant if there is an absolute decrease in the case fatality rate of 20% or more, compared to SC alone
Secondary Outcome Measures
- Number of Participants With 30 Days Survival [30 days]
Effect of convalescent plasma in improving patients survival at day 30
- Titer of Ebola Viral RNA [30 days]
To assess the relationship between EVD antibody levels (EBOV IgG) in donated plasma and the changes in levels of viral RNA in patients who received Convalescent Plasma. The outcome shows the overall association between antibody dose category and change in Cycle threshold (Ct) value pre and post transfusion (Ct is the number of cycles that have to be run before reaching a threshold value of a positive result).
- Titer of Ebola Viral RNA [30 days]
To assess the relationship between EVD antibody levels (neutralizing antibodies) in donated plasma and the changes in levels of viral RNA in patients who received Convalescent Plasma. The outcome shows the overall association between antibody dose category and change in Cycle threshold (Ct) value pre and post transfusion (Ct is the number of cycles that have to be run before reaching a threshold value of a positive result).
- Number of Participants Who Died Corresponding to EV Antibody Levels (Anti-EBOV IgG) [14 days]
To assess the relationship between EVD antibody levels (anti-EBOV IgG) and death in patients who received Convalescent Plasma
- Number of Participants Who Died Corresponding to EV Antibody Levels (Neutralizing Antibodies) [14 days]
To assess the relationship between EVD antibody levels (neutralizing antibodies) and death in patients who received CP
- Number of Transfusion-related Serious Adverse Reactions (SARs) [30 days]
To assess the occurrence of serious adverse reactions (SARs) related to CP transfusion in Ebola patients
- Number of Professional Safety Incidents [9 months]
To assess the occurrence of safety risks related to CP transfusion in health workers administering the treatments. This will be observed throughout the study
- Mortality Risk Factor: Ct [30 days]
To determine Ct as risk factor for mortality despite administration of CP.
- Mortality Risk Factor: Age [30 days]
To determine age as risk factor for mortality despite administration of CP.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
PCR-confirmed, symptomatic infection with Ebola virus
-
Patient's, guardian's or representatives' willingness to provide written informed consent
Exclusion Criteria:
A patient is not eligible to receive CP if they meet one of the following criteria:
-
History of allergic reaction to blood or plasma products (as judged by the investigator or treating physician);
-
Medical conditions in which receipt of additional fluid related to the transfusion (250-500 ml or in the case of children 10 ml/kg) may be detrimental to the patient (e.g. decompensated congestive heart failure or renal failure).
-
Patients in shock unresponsive to fluid challenge
-
Patients in shock with signs of multi-organ failure, defined as oliguria/anuria AND impaired consciousness AND/OR jaundice
-
Condition of patient where the procedure of plasma administration carries a risk for the staff
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ebola Treatment Center | Donka | Guinea |
Sponsors and Collaborators
- Institute of Tropical Medicine, Belgium
- National Blood Transfusion Centre (NBTC), Conakry, Guinea
- Gamal Abdel Nasser University of Conakry
- National Center for Training and Research of Maferinyah, Guinea
- Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
- University of Oxford
- University of Liverpool
- London School of Hygiene and Tropical Medicine
- Aix Marseille Université
- UBIVE, Institut Pasteur, Paris, France
- Institut National de la Santé Et de la Recherche Médicale, France
- Etablissement Français du Sang
- Belgian Red Cross
- Institut Pasteur, Dakar, Sénégal
- Médecins Sans Frontières, Belgium
- World Health Organization
- International Severe Acute Respiratory and Emerging Infection Consortium
Investigators
- Study Chair: Johan van Griensven, MD, ITM
- Principal Investigator: Niankoye Haba, MD, National Blood Transfusion Centre (NBTC), Conakry, Guinea
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ITM0614
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Convalescent Plasma | Standard Care |
|---|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. | The control arm will consist of historical controls having being treated with standard of care |
| Period Title: Overall Study | ||
| STARTED | 99 | 507 |
| COMPLETED | 84 | 418 |
| NOT COMPLETED | 15 | 89 |
Baseline Characteristics
| Arm/Group Title | Convalescent Plasma | Standard Care | Total |
|---|---|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. | The control arm will consist of historical controls having being treated with standard of care | Total of all reporting groups |
| Overall Participants | 84 | 418 | 502 |
| Age (years) [Median (Full Range) ] | |||
| Median (Full Range) [years] |
29
|
28
|
28
|
| Age, Customized (Count of Participants) | |||
| <5 years |
5
6%
|
23
5.5%
|
28
5.6%
|
| 5-15 years |
8
9.5%
|
53
12.7%
|
61
12.2%
|
| 16-44 years |
56
66.7%
|
258
61.7%
|
314
62.5%
|
| >45 years |
15
17.9%
|
84
20.1%
|
99
19.7%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
48
57.1%
|
210
50.2%
|
258
51.4%
|
| Male |
36
42.9%
|
208
49.8%
|
244
48.6%
|
| Cycle-threshold on PCR (Number of cycles) [Median (Full Range) ] | |||
| Median (Full Range) [Number of cycles] |
27.3
|
26.0
|
26.3
|
| Number of participants per PCR Cycle-threshold interval (Count of Participants) | |||
| <25 cycles |
21
25%
|
159
38%
|
180
35.9%
|
| 25.0-29.9 cycles |
41
48.8%
|
183
43.8%
|
224
44.6%
|
| >29.9 cycles |
22
26.2%
|
76
18.2%
|
98
19.5%
|
| Nausea and vomiting (Count of Participants) | |||
| Count of Participants [Participants] |
42
50%
|
203
48.6%
|
245
48.8%
|
| Diarrhea (Count of Participants) | |||
| Count of Participants [Participants] |
29
34.5%
|
155
37.1%
|
184
36.7%
|
| Weakness or asthenia (Count of Participants) | |||
| Count of Participants [Participants] |
77
91.7%
|
353
84.4%
|
430
85.7%
|
| Pain (Count of Participants) | |||
| Count of Participants [Participants] |
73
86.9%
|
342
81.8%
|
415
82.7%
|
| Cough (Count of Participants) | |||
| Count of Participants [Participants] |
11
13.1%
|
40
9.6%
|
51
10.2%
|
| Difficulty breathing (Count of Participants) | |||
| Count of Participants [Participants] |
4
4.8%
|
11
2.6%
|
15
3%
|
| Difficulty swallowing (Count of Participants) | |||
| Count of Participants [Participants] |
15
17.9%
|
39
9.3%
|
54
10.8%
|
| Hiccups (Count of Participants) | |||
| Count of Participants [Participants] |
7
8.3%
|
38
9.1%
|
45
9%
|
| Eye redness (Count of Participants) | |||
| Count of Participants [Participants] |
34
40.5%
|
83
19.9%
|
117
23.3%
|
| Unusual bleeding (Count of Participants) | |||
| Count of Participants [Participants] |
5
6%
|
21
5%
|
26
5.2%
|
| Disorientation or agitation (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
2
0.5%
|
2
0.4%
|
| Anuria (Count of Participants) | |||
| Count of Participants [Participants] |
1
1.2%
|
1
0.2%
|
2
0.4%
|
| Seizures (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
1
0.2%
|
1
0.2%
|
| Duration of symptoms >6 days (Count of Participants) | |||
| Count of Participants [Participants] |
14
16.7%
|
203
48.6%
|
217
43.2%
|
| Coexisting chronic medical condition (Count of Participants) | |||
| Infectious |
1
1.2%
|
2
0.5%
|
3
0.6%
|
| Noninfectious |
1
1.2%
|
3
0.7%
|
4
0.8%
|
Outcome Measures
| Title | Survival at Day 14 After Start of Intervention |
|---|---|
| Description | Effect of convalescent plasma in improving patients survival at day 14; it will be considered clinically significant if there is an absolute decrease in the case fatality rate of 20% or more, compared to SC alone |
| Time Frame | 14 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Convalescent Plasma | Standard Care |
|---|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. | The control arm will consist of historical controls having being treated with standard of care |
| Measure Participants | 84 | 418 |
| Count of Participants [Participants] |
58
69%
|
260
62.2%
|
| Title | Number of Participants With 30 Days Survival |
|---|---|
| Description | Effect of convalescent plasma in improving patients survival at day 30 |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Outcome was only measured in the intervention group. Data (historical) not available for "Standard care" group. |
| Arm/Group Title | Convalescent Plasma |
|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. |
| Measure Participants | 84 |
| Count of Participants [Participants] |
57
67.9%
|
| Title | Titer of Ebola Viral RNA |
|---|---|
| Description | To assess the relationship between EVD antibody levels (EBOV IgG) in donated plasma and the changes in levels of viral RNA in patients who received Convalescent Plasma. The outcome shows the overall association between antibody dose category and change in Cycle threshold (Ct) value pre and post transfusion (Ct is the number of cycles that have to be run before reaching a threshold value of a positive result). |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Total dose for antibody levels was categorized in three equal-sized groups (tertiles), with the lowest dose category as reference. 71 out of 84 participants were defined as the analysis population. Children (<16 years) were excluded from the analysis as dosing of CP was done according to body weight, which was not recorded for many adult patients. |
| Arm/Group Title | Convalescent Plasma |
|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. |
| Measure Participants | 71 |
| Lowest dose (antibody range 176.4 - 511.9) |
1
|
| Middle dose (antibody range 513.3 - 740.6) |
3.24
|
| Highest dose (antibody range 747.9 - 1628.7) |
2.34
|
| Title | Titer of Ebola Viral RNA |
|---|---|
| Description | To assess the relationship between EVD antibody levels (neutralizing antibodies) in donated plasma and the changes in levels of viral RNA in patients who received Convalescent Plasma. The outcome shows the overall association between antibody dose category and change in Cycle threshold (Ct) value pre and post transfusion (Ct is the number of cycles that have to be run before reaching a threshold value of a positive result). |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Total dose for antibody levels was categorized in three equal-sized groups (tertiles), with the lowest dose category as reference. 71 out of 84 participants were defined as the analysis population. Children (<16 years) were excluded from the analysis as dosing of CP was done according to body weight, which was not recorded for many adult patients. |
| Arm/Group Title | Convalescent Plasma |
|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. |
| Measure Participants | 71 |
| Lowest dose ((antibody range 176.4 - 511.9) |
1
|
| Middle dose (antibody range 513.3 - 740.6) |
0.30
|
| Highest dose (antibody range 747.9 - 1628.7) |
-0.46
|
| Title | Number of Participants Who Died Corresponding to EV Antibody Levels (Anti-EBOV IgG) |
|---|---|
| Description | To assess the relationship between EVD antibody levels (anti-EBOV IgG) and death in patients who received Convalescent Plasma |
| Time Frame | 14 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Overall Number of Participants Analyzed divided in 3 equal groups depending on total dose of antibodies. 71 out of 84 participants were defined as the analysis population. Children (<16 years) were excluded from analysis as dosing of CP was done according to body weight, which was not recorded for many adult patients. |
| Arm/Group Title | Convalescent Plasma |
|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. |
| Measure Participants | 71 |
| Low (antibody range 176.4 - 511.9) |
5
6%
|
| Medium (antibody range 513.3 - 740.6) |
11
13.1%
|
| High (antibody range 747.9 - 1628.7) |
8
9.5%
|
| Title | Number of Participants Who Died Corresponding to EV Antibody Levels (Neutralizing Antibodies) |
|---|---|
| Description | To assess the relationship between EVD antibody levels (neutralizing antibodies) and death in patients who received CP |
| Time Frame | 14 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Overall Number of Participants Analyzed divided in 3 equal groups depending on total dose of antibodies. Children (<16 years) were excluded from analysis as dosing of CP was done according to body weight, which was not recorded for many adult patients. |
| Arm/Group Title | Convalescent Plasma |
|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. |
| Measure Participants | 71 |
| Low(antibody range 176.4 - 511.9) |
6
7.1%
|
| Medium (antibody range 513.3 - 740.6) |
8
9.5%
|
| High (antibody range 747.9 - 1628.7) |
10
11.9%
|
| Title | Number of Transfusion-related Serious Adverse Reactions (SARs) |
|---|---|
| Description | To assess the occurrence of serious adverse reactions (SARs) related to CP transfusion in Ebola patients |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Convalescent Plasma |
|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. |
| Measure Participants | 99 |
| Number [SARs] |
0
|
| Title | Number of Professional Safety Incidents |
|---|---|
| Description | To assess the occurrence of safety risks related to CP transfusion in health workers administering the treatments. This will be observed throughout the study |
| Time Frame | 9 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Overall Number of Participants Analyzed refers to health workers administering CP; not to the participants receiving CP. |
| Arm/Group Title | Convalescent Plasma |
|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. |
| Measure Participants | 12 |
| Number [Professional safety incidents] |
0
|
| Title | Mortality Risk Factor: Ct |
|---|---|
| Description | To determine Ct as risk factor for mortality despite administration of CP. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pre-specified sub-group comparison |
| Arm/Group Title | Convalescent Plasma | Standard Care |
|---|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. | The control arm will consist of historical controls having being treated with standard of care |
| Measure Participants | 84 | 418 |
| 10-24.9 cycles |
11
13.1%
|
90
21.5%
|
| 25-29.9 cycles |
11
13.1%
|
56
13.4%
|
| 30-39.9 cycles |
4
4.8%
|
12
2.9%
|
| Title | Mortality Risk Factor: Age |
|---|---|
| Description | To determine age as risk factor for mortality despite administration of CP. |
| Time Frame | 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Pre-specified sub-group comparison |
| Arm/Group Title | Convalescent Plasma | Standard Care |
|---|---|---|
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. | The control arm will consist of historical controls having being treated with standard of care |
| Measure Participants | 84 | 418 |
| <5 years old |
1
1.2%
|
15
3.6%
|
| 5-15 years old |
1
1.2%
|
10
2.4%
|
| 16-44 years old |
16
19%
|
90
21.5%
|
| >45 years old |
8
9.5%
|
43
10.3%
|
Adverse Events
| Time Frame | All adverse events related to the intervention up to 4 hours after completion of the transfusion. All deaths possibly related to the intervention up to 14 days after completion of the transfusion. | |
|---|---|---|
| Adverse Event Reporting Description | Due to the nature of the symptoms of EVD (high mortality rate, hospital admissions, disability and life-threatening conditions), the investigation of safety and tolerability of the intervention will focus on Adverse Reactions. An Adverse Reaction is any untoward and unintended response in a participant to the study treatment, which is related (or has a reasonable possibility of being related) to any dose of the investigational product administered to that participant. | |
| Arm/Group Title | Convalescent Plasma | |
| Arm/Group Description | Convalescent Plasma: 400-500 mL from two donors (2 x 200-250 ml) and 10mL/kg for small adults and children <45kg Convalescent Plasma: Patients will be treated with plasma from recovered EVD patients. No data from "standard care" group available as this is based on historical data. | |
All Cause Mortality |
||
| Convalescent Plasma | ||
| Affected / at Risk (%) | # Events | |
| Total | 26/84 (31%) | |
Serious Adverse Events |
||
| Convalescent Plasma | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/84 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Convalescent Plasma | ||
| Affected / at Risk (%) | # Events | |
| Total | 8/84 (9.5%) | |
| General disorders | ||
| Increase in temperature | 5/84 (6%) | |
| Nausea | 1/84 (1.2%) | |
| Skin and subcutaneous tissue disorders | ||
| Itching or skin rash | 4/84 (4.8%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
| Name/Title | Prof. Dr. Johan van Griensven |
|---|---|
| Organization | Institute of Tropical Medicine |
| Phone | +3232476426 |
| jvangriensven@itg.be |
- ITM0614