Trial Outcomes & Findings for Investigational Therapeutics for the Treatment of People With Ebola Virus Disease (NCT NCT03719586)
NCT ID: NCT03719586
Last Updated: 2021-09-08
Results Overview
Number of Participants with Mortality by Day 28
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
681 participants
Primary outcome timeframe
28 days
Results posted on
2021-09-08
Participant Flow
Of 681 patients enrolled, one pt was excluded due to a false + PCR result, 50 patients were enrolled prior to addition of the REGN-EB3 arm, and 7 patients underwent randomization during a 2-week period when ZMapp was unavailable. This led to 631 evaluable patients whose timing of enrollment permitted contemporaneous randomization to one of the three study arms versus the control (ZMapp) arm, as stipulated in version 3.0 of the protocol and at outlined in the Statistical Analysis Plan.
Statistical comparisons for efficacy between the three treatment arms and ZMapp as the control arm were limited to those time periods when contemporaneous enrollments could occur. So, for example, comparison between REGN-EB3 recipients and ZMapp recipients were limited to the time period beginning in January 2019 because that is when the REGN-EB3 arm was added as a fourth arm to the study.
Participant milestones
| Measure |
Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)
Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg remdesivir 2.5 mg/kg)
|
Arm B: MAb114 Plus Optimized Standard of Care (oSOC)
MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)
REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)
ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
177
|
176
|
158
|
169
|
|
Overall Study
COMPLETED
|
169
|
169
|
154
|
169
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
4
|
0
|
Reasons for withdrawal
| Measure |
Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)
Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg remdesivir 2.5 mg/kg)
|
Arm B: MAb114 Plus Optimized Standard of Care (oSOC)
MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)
REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)
ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
|
|---|---|---|---|---|
|
Overall Study
"not completed" simply refers to pts who could not be contemporaneously compared to the ZMapp arm
|
8
|
7
|
4
|
0
|
Baseline Characteristics
Investigational Therapeutics for the Treatment of People With Ebola Virus Disease
Baseline characteristics by cohort
| Measure |
Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)
n=175 Participants
Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg remdesivir 2.5 mg/kg)
|
Arm B: MAb114 Plus Optimized Standard of Care (oSOC)
n=174 Participants
MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)
n=155 Participants
REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)
n=169 Participants
ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
|
Total
n=673 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
27.4 years
STANDARD_DEVIATION 18.5 • n=7 Participants
|
28.2 years
STANDARD_DEVIATION 18.2 • n=5 Participants
|
29.7 years
STANDARD_DEVIATION 16.8 • n=4 Participants
|
28.8 years
STANDARD_DEVIATION 17.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
374 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
82 Participants
n=4 Participants
|
299 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
175 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
169 Participants
n=4 Participants
|
673 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
Congo, The Democratic Republic of the
|
175 participants
n=5 Participants
|
174 participants
n=7 Participants
|
155 participants
n=5 Participants
|
169 participants
n=4 Participants
|
673 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: patients randomized to receive one of the 4 investigational treatments
Number of Participants with Mortality by Day 28
Outcome measures
| Measure |
Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)
n=175 Participants
Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg remdesivir 2.5 mg/kg)
|
Arm B: MAb114 Plus Optimized Standard of Care (oSOC)
n=174 Participants
MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)
n=155 Participants
REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)
n=169 Participants
ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
|
|---|---|---|---|---|
|
Mortality
|
93 deaths
|
61 deaths
|
52 deaths
|
84 deaths
|
SECONDARY outcome
Timeframe: up to Day 28Population: patients in all treatment arms who were randomized contemporaneously with those randomized to the control arm (Arm D).
This was a measure of the median number of days that it took for the serum PCR to first turn negative after having been positive throughout the patient's earlier course.
Outcome measures
| Measure |
Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)
n=175 Participants
Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg remdesivir 2.5 mg/kg)
|
Arm B: MAb114 Plus Optimized Standard of Care (oSOC)
n=174 Participants
MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)
n=155 Participants
REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)
n=169 Participants
ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
|
|---|---|---|---|---|
|
Time in Days to First Negative Ebola Virus RT-PCR in Blood.
|
NA Days
Interval 0.0 to 28.0
Among patients in the remdesivir group, the estimated median time was actually more than 28 days because mortality exceeded 50% and expired patients were assigned a time of "\>28 days".
|
16 Days
Interval 0.0 to 28.0
|
15 Days
Interval 0.0 to 28.0
|
27 Days
Interval 0.0 to 28.0
|
SECONDARY outcome
Timeframe: Days 1, 2, 3, 4, 6, 8, 10, 14, and 28.Population: these are the median CTnp PCR measurements performed serially on patients at defined timepoints on the 4 treatment arms
These are the median CTnp pCR values measured serially on the 4 treatment arms as per protocol. caveats: Undetectable ctNP values are imputed as ctNP=45.0 (the limit of detection). Missing values (due to gaps in sample collection, discharge, or death) are handled by carrying forward the last observation. The Day 28 visit includes a ±7-day visit window. The priority for defining the ctNP value for this timepoint, according to days post-randomization, is: 28, 27, 29, 26, 30, 25, 31, 24, 32, 23, 33, 22, 34, 21. For example, the ctNP result from the sample collected 26 days post-randomization will only be used for this timepoint if there are no sample results for 28, 27, or 29 days post-randomization.
Outcome measures
| Measure |
Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)
n=175 Participants
Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg remdesivir 2.5 mg/kg)
|
Arm B: MAb114 Plus Optimized Standard of Care (oSOC)
n=174 Participants
MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)
n=155 Participants
REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)
n=169 Participants
ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
|
|---|---|---|---|---|
|
Viremia as Determined by CTnp Values on PCR
Day 6
|
28.6 median CTnp PCR values
Interval 10.0 to 45.0
|
32.7 median CTnp PCR values
Interval 10.0 to 45.0
|
32.7 median CTnp PCR values
Interval 10.0 to 45.0
|
29.4 median CTnp PCR values
Interval 10.0 to 45.0
|
|
Viremia as Determined by CTnp Values on PCR
ar randomization
|
23.1 median CTnp PCR values
Interval 10.0 to 45.0
|
23.4 median CTnp PCR values
Interval 10.0 to 45.0
|
22.8 median CTnp PCR values
Interval 10.0 to 45.0
|
23.1 median CTnp PCR values
Interval 10.0 to 45.0
|
|
Viremia as Determined by CTnp Values on PCR
Day 1
|
22.2 median CTnp PCR values
Interval 10.0 to 45.0
|
23.7 median CTnp PCR values
Interval 10.0 to 45.0
|
23.3 median CTnp PCR values
Interval 10.0 to 45.0
|
22.8 median CTnp PCR values
Interval 10.0 to 45.0
|
|
Viremia as Determined by CTnp Values on PCR
Day 2
|
23.0 median CTnp PCR values
Interval 10.0 to 45.0
|
25.1 median CTnp PCR values
Interval 10.0 to 45.0
|
25.2 median CTnp PCR values
Interval 10.0 to 45.0
|
23.7 median CTnp PCR values
Interval 10.0 to 45.0
|
|
Viremia as Determined by CTnp Values on PCR
Day 3
|
23.7 median CTnp PCR values
Interval 10.0 to 45.0
|
28.6 median CTnp PCR values
Interval 10.0 to 45.0
|
28.1 median CTnp PCR values
Interval 10.0 to 45.0
|
24.2 median CTnp PCR values
Interval 10.0 to 45.0
|
|
Viremia as Determined by CTnp Values on PCR
Day 4
|
25.4 median CTnp PCR values
Interval 10.0 to 45.0
|
30.9 median CTnp PCR values
Interval 10.0 to 45.0
|
30.5 median CTnp PCR values
Interval 10.0 to 45.0
|
25.7 median CTnp PCR values
Interval 10.0 to 45.0
|
|
Viremia as Determined by CTnp Values on PCR
Day 8
|
30.1 median CTnp PCR values
Interval 10.0 to 45.0
|
34.4 median CTnp PCR values
Interval 10.0 to 45.0
|
34.5 median CTnp PCR values
Interval 10.0 to 45.0
|
32.2 median CTnp PCR values
Interval 10.0 to 45.0
|
|
Viremia as Determined by CTnp Values on PCR
Day 10
|
31.6 median CTnp PCR values
Interval 10.0 to 45.0
|
36.3 median CTnp PCR values
Interval 10.0 to 45.0
|
36.3 median CTnp PCR values
Interval 10.0 to 45.0
|
33.2 median CTnp PCR values
Interval 10.0 to 45.0
|
|
Viremia as Determined by CTnp Values on PCR
Day 14
|
33.2 median CTnp PCR values
Interval 10.0 to 45.0
|
39.1 median CTnp PCR values
Interval 10.0 to 45.0
|
39.8 median CTnp PCR values
Interval 10.0 to 45.0
|
35.2 median CTnp PCR values
Interval 10.0 to 45.0
|
|
Viremia as Determined by CTnp Values on PCR
Day 28
|
37.6 median CTnp PCR values
Interval 10.0 to 45.0
|
45.0 median CTnp PCR values
Interval 10.0 to 45.0
|
45.0 median CTnp PCR values
Interval 10.0 to 45.0
|
38.4 median CTnp PCR values
Interval 10.0 to 45.0
|
SECONDARY outcome
Timeframe: up to Day 58Population: This table shows the number of SAEs adjudicated to be potentially related to study drug infusion for each of the four study arms. There were 4 SAEs reported in a total of 3 patients.
The number of Serious Adverse Events that were tentatively ascribed to one of the four treatment arms by the site investigator and, upon extensive further review and adjudication by an independent Pharmacovigilance committee, were still felt potentially attributable to study drug as opposed to the underlying Ebola infection.
Outcome measures
| Measure |
Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)
n=1409 doses
Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg remdesivir 2.5 mg/kg)
|
Arm B: MAb114 Plus Optimized Standard of Care (oSOC)
n=171 doses
MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)
n=150 doses
REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)
n=361 doses
ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
|
|---|---|---|---|---|
|
Incidence of Serious Adverse Events/AEs
|
1 number of SAEs
|
0 number of SAEs
|
0 number of SAEs
|
3 number of SAEs
|
Adverse Events
Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 93 deaths
Arm B: MAb114 Plus Optimized Standard of Care (oSOC)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 61 deaths
Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 52 deaths
Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 84 deaths
Serious adverse events
| Measure |
Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)
n=175 participants at risk
Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg remdesivir 2.5 mg/kg)
|
Arm B: MAb114 Plus Optimized Standard of Care (oSOC)
n=174 participants at risk
MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)
n=155 participants at risk
REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)
n=169 participants at risk
ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
|
|---|---|---|---|---|
|
Gastrointestinal disorders
death
|
0.57%
1/175 • Number of events 1 • Patients were evaluated from time of randomization (Day 1) through Day 58 of study.
Only SAEs that were felt by site investigators to be possibly study treatment-related and not due to underlying Ebola virus disease were reported, then subjected to rigorous review, additional data collection as necessary, and adjudication by an independent Pharmacovigilance team in order to separate those SAEs still most likely due to underlying Ebola infection from those potentially attributable to infusion(s) of one of the four assigned study drugs.
|
0.00%
0/174 • Patients were evaluated from time of randomization (Day 1) through Day 58 of study.
Only SAEs that were felt by site investigators to be possibly study treatment-related and not due to underlying Ebola virus disease were reported, then subjected to rigorous review, additional data collection as necessary, and adjudication by an independent Pharmacovigilance team in order to separate those SAEs still most likely due to underlying Ebola infection from those potentially attributable to infusion(s) of one of the four assigned study drugs.
|
0.00%
0/155 • Patients were evaluated from time of randomization (Day 1) through Day 58 of study.
Only SAEs that were felt by site investigators to be possibly study treatment-related and not due to underlying Ebola virus disease were reported, then subjected to rigorous review, additional data collection as necessary, and adjudication by an independent Pharmacovigilance team in order to separate those SAEs still most likely due to underlying Ebola infection from those potentially attributable to infusion(s) of one of the four assigned study drugs.
|
1.2%
2/169 • Number of events 3 • Patients were evaluated from time of randomization (Day 1) through Day 58 of study.
Only SAEs that were felt by site investigators to be possibly study treatment-related and not due to underlying Ebola virus disease were reported, then subjected to rigorous review, additional data collection as necessary, and adjudication by an independent Pharmacovigilance team in order to separate those SAEs still most likely due to underlying Ebola infection from those potentially attributable to infusion(s) of one of the four assigned study drugs.
|
Other adverse events
| Measure |
Arm A: Remdesivir Plus Optimized Standard of Care (oSOC)
n=175 participants at risk
Remdesivir: Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight \>= 40 kg and for pediatric patients weighing \< 40 kg remdesivir 2.5 mg/kg)
|
Arm B: MAb114 Plus Optimized Standard of Care (oSOC)
n=174 participants at risk
MAb114: 50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC)
n=155 participants at risk
REGN-EB3: 150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
|
Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC)
n=169 participants at risk
ZMapp: Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
|
|---|---|---|---|---|
|
Surgical and medical procedures
incomplete study drug infusion(s)
|
3.4%
6/175 • Number of events 6 • Patients were evaluated from time of randomization (Day 1) through Day 58 of study.
Only SAEs that were felt by site investigators to be possibly study treatment-related and not due to underlying Ebola virus disease were reported, then subjected to rigorous review, additional data collection as necessary, and adjudication by an independent Pharmacovigilance team in order to separate those SAEs still most likely due to underlying Ebola infection from those potentially attributable to infusion(s) of one of the four assigned study drugs.
|
0.57%
1/174 • Number of events 1 • Patients were evaluated from time of randomization (Day 1) through Day 58 of study.
Only SAEs that were felt by site investigators to be possibly study treatment-related and not due to underlying Ebola virus disease were reported, then subjected to rigorous review, additional data collection as necessary, and adjudication by an independent Pharmacovigilance team in order to separate those SAEs still most likely due to underlying Ebola infection from those potentially attributable to infusion(s) of one of the four assigned study drugs.
|
1.3%
2/155 • Number of events 2 • Patients were evaluated from time of randomization (Day 1) through Day 58 of study.
Only SAEs that were felt by site investigators to be possibly study treatment-related and not due to underlying Ebola virus disease were reported, then subjected to rigorous review, additional data collection as necessary, and adjudication by an independent Pharmacovigilance team in order to separate those SAEs still most likely due to underlying Ebola infection from those potentially attributable to infusion(s) of one of the four assigned study drugs.
|
3.6%
6/169 • Number of events 6 • Patients were evaluated from time of randomization (Day 1) through Day 58 of study.
Only SAEs that were felt by site investigators to be possibly study treatment-related and not due to underlying Ebola virus disease were reported, then subjected to rigorous review, additional data collection as necessary, and adjudication by an independent Pharmacovigilance team in order to separate those SAEs still most likely due to underlying Ebola infection from those potentially attributable to infusion(s) of one of the four assigned study drugs.
|
Additional Information
Dr. Richard T. Davey, Jr., M.D., U.S. study PI
NIAID/NIH
Phone: 301-496-8029
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place