Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02818582 | GS-5734 to Assess the Antiviral Activity, Longer-Term Clearance of Ebola Virus, and Safety in Male Ebola Survivors With Evidence of Ebola Virus Persistence in Semen | PHASE2 | COMPLETED | 38 | — | — | Jul 1, 2016 | Aug 31, 2020 | Feb 15, 2022 | 2 | Guinea, Liberia |
Mean assay negativity rate (ANR) of semen samples collected during the treatment phase on days 4, 8, 11, 16, 20, 24, \& 28. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (7). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
Mean assay negativity rate (ANR) of semen samples collected during the follow-up phase on weeks 8, 12, 16, 20, \& 24. Average of all time points for negative values were compiled for the collected assay values. Negativity rate per participant was calculated using all time points by calculating the number of negative results over total number of time points (5). The assay negativity rate was averaged over all participants to get the mean assay negativity rate.
| Arm | Type | Description |
|---|---|---|
| GS-5734 100mg given intravenously daily for 5 days | ACTIVE_COMPARATOR | Male Ebola survivors with persistent Ebola virus in their semen were given GS-5734 100mg intravenously daily for 5 days |
| Normal saline intravenously for 5 days | PLACEBO_COMPARATOR | Male Ebola survivors with persistent Ebola virus in their semen were given normal saline intravenously daily for 5 days |
| Name | Type | Description |
|---|---|---|
| GS-5734 | DRUG | Daily GS-5734 delivered intravenously (IV) for 5 days |
| Placebo Comparator | OTHER | Placebo delivered intravenously (IV) for 5 days. |
* INCLUSION CRITERIA: Individuals must meet all of the following criteria to be eligible for study participation: * Men more than or equal to 18 years of age. * One of two semen samples with Ebola virus RNA detection (defined as a positive PCR for NP or GP using the GeneXpert assay within 42 days ...