Trial · NCT03719586
Investigational Therapeutics for the Treatment of People With Ebola Virus Disease
NCT03719586, Phase 2, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2021-09-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Investigational Therapeutics for the Treatment of People With Ebola Virus Disease. Trials, record NCT03719586. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03719586
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Investigational Therapeutics for the Treatment of People With Ebola Virus Disease
- NCT number
- NCT03719586
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 681 participants, actual
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Conditions
- Ebola Virus
- Interventions
- ZMapp, Remdesivir, MAb114, REGN-EB3
- First posted
- 2018-10-25
- Last updated
- 2021-09-08
- Results first posted
- 2021-09-08
- Limitations and caveats
By design, efficacy comparisons between the 3 investigational treatment arms and the ZMapp control arm were always restricted to those time periods when both ZMapp and the study drug were available, and there were brief periods when ZMapp became unavailable, accounting for why the total numbers compared between the arms are sometimes lower than the total number of enrolled patients. Also, the REGN-EB3 arm started enrolling later than the other three arms due to a protocol modification.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mortality | 28 days | Number of Participants with Mortality by Day 28 |
| Secondary | Time in Days to First Negative Ebola Virus RT-PCR in Blood. | up to Day 28 | 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. |
| Secondary | Viremia as Determined by CTnp Values on PCR | Days 1, 2, 3, 4, 6, 8, 10, 14, and 28. | 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. |
| Secondary | Incidence of Serious Adverse Events/AEs | up to Day 58 | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mortality | 28 days | patients randomized to receive one of the 4 investigational treatments | deaths | NUMBER |
| SECONDARY | Time in Days to First Negative Ebola Virus RT-PCR in Blood. | up to Day 28 | patients in all treatment arms who were randomized contemporaneously with those randomized to the control arm (Arm D). | Days | MEDIAN |
| SECONDARY | Viremia as Determined by CTnp Values on PCR | Days 1, 2, 3, 4, 6, 8, 10, 14, and 28. | these are the median CTnp PCR measurements performed serially on patients at defined timepoints on the 4 treatment arms | median CTnp PCR values | MEDIAN |
| SECONDARY | Incidence of Serious Adverse Events/AEs | up to Day 58 | 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. | number of SAEs | NUMBER |
Source ClinicalTrials.gov
Results by group52
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mortality | Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 93 | deaths | ||
| Mortality | Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 61 | deaths | ||
| Mortality | Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 52 | deaths | ||
| Mortality | Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 84 | deaths | ||
| Time in Days to First Negative Ebola Virus RT-PCR in Blood. | Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | NA | Full Range 0 to 28 | Days | |
| Time in Days to First Negative Ebola Virus RT-PCR in Blood. | Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 16 | Full Range 0 to 28 | Days | |
| Time in Days to First Negative Ebola Virus RT-PCR in Blood. | Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 15 | Full Range 0 to 28 | Days | |
| Time in Days to First Negative Ebola Virus RT-PCR in Blood. | Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 27 | Full Range 0 to 28 | Days | |
| Viremia as Determined by CTnp Values on PCR | Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | ar randomization | 23.1 | Full Range 10 to 45 | median CTnp PCR values |
| Viremia as Determined by CTnp Values on PCR | Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | ar randomization | 23.4 | Full Range 10 to 45 | median CTnp PCR values |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 177 | |
| Overall Study | STARTED | Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 176 | |
| Overall Study | STARTED | Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 158 | |
| Overall Study | STARTED | Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 169 | |
| Overall Study | COMPLETED | Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 169 | |
| Overall Study | COMPLETED | Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 169 | |
| Overall Study | COMPLETED | Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 154 | |
| Overall Study | COMPLETED | Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 169 | |
| Overall Study | NOT COMPLETED | Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 8 | |
| Overall Study | NOT COMPLETED | Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | incomplete study drug infusion(s) | Surgical and medical procedures | Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 6 | 175 | 6 |
| other | incomplete study drug infusion(s) | Surgical and medical procedures | Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 1 | 174 | 1 |
| other | incomplete study drug infusion(s) | Surgical and medical procedures | Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 2 | 155 | 2 |
| other | incomplete study drug infusion(s) | Surgical and medical procedures | Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 6 | 169 | 6 |
| serious | death | Gastrointestinal disorders | Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 1 | 175 | 1 |
| serious | death | Gastrointestinal disorders | Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 0 | 174 | 0 |
| serious | death | Gastrointestinal disorders | Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 0 | 155 | 0 |
| serious | death | Gastrointestinal disorders | Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 2 | 169 | 3 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 93 | 175 |
| Total, all-cause mortality | Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 61 | 174 |
| Total, all-cause mortality | Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 52 | 155 |
| Total, all-cause mortality | Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 84 | 169 |
| Total, other adverse events | Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 6 | 175 |
| Total, other adverse events | Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 1 | 174 |
| Total, other adverse events | Arm C: REGN-EB3 Plus Optimized Standard of Care (oSOC) | 2 | 155 |
| Total, other adverse events | Control Arm (D): ZMapp Plus Optimized Standard of Care (oSOC) | 6 | 169 |
| Total, serious adverse events | Arm A: Remdesivir Plus Optimized Standard of Care (oSOC) | 1 | 175 |
| Total, serious adverse events | Arm B: MAb114 Plus Optimized Standard of Care (oSOC) | 0 | 174 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03719586
GET https://conductscience.org/api/trials/v1/NCT03719586/results?page=2