| Primary | Cumulative Proportion With Clinical Resolution by Day 29 | Clinical resolution defined as all skin lesions scabbed, desquamated, or healed, and visible mucosal lesions healed. The cumulative proportion with clinical resolution was estimated using the Aalen-Johansen estimator. The treatment effect, i.e., the subdistribution hazard ratio of tecovirimat relative to placebo, was estimated using the Fine and Gray subdistribution proportional hazards model. All-cause death, start of open-label tecovirimat due to disease progression or severe pain, and use of other antivirals with expected activity against mpox were treated as competing events. Follow-up time was censored at last contact. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox and one or more skin or visible mucosal lesions that were able to be followed to resolution according to assigned treatment arm. | Posted | | Number | 95% Confidence Interval | cumulative proportion of participants | | From study entry through 28 days of follow-up (i.e., Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
| | OG002 | Open-Label Tecovirimat (Arm C) | Participants assigned to open-label tecovirimat. Tecovirimat Oral Capsule (Open Label):
- Participants weighing <3 kg - Tecovirimat 33.3 mg every 12 hours for 14 days
- Participants weighing 3 kg to less than 6 kg- Tecovirimat 50 mg every 12 hours for 14 days
- Participants weighing 6 kg to less than 13 kg - Tecovirimat 100 mg every 12 hours for 14 days
- Participants weighing 13 kg to less than 25 kg - Tecovirimat 200 mg every 12 hours for 14 days
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
|
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.83(0.77 to 0.87)
- OG0010.84(0.76 to 0.90)
- OG0020.85(0.79 to 0.90)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Fine and Gray | | 0.89 | Threshold for statistical significance was 0.01907. Significance level used adjusts for interim looks according to the Lan and DeMets spending function analog of the O'Brien-Fleming boundaries. | Subdistribution hazard ratio | 0.98 | | | 2-Sided | 98.09 | 0.74 | 1.31 | | | Subdistribution hazard ratio expressed as tecovirimat relative to placebo. Nominal 98.09% confidence interval presented adjusts for interim looks according to the Lan and DeMets spending function analog of the O'Brien-Fleming boundaries. | | Superiority | |
|
| Secondary | Mean Time-weighted Average of Pain Intensity Difference Over 5 Days of Treatment | Pain was measured on 11-point numerical rating scale (NRS) where 0 = no pain and 10 = worst possible pain. Pain intensity difference at ith day of treatment (i = 2, ..., 6) calculated as NRS pain score at baseline (last available pre-treatment) minus NRS pain score on ith day of treatment Time-weighted average of pain intensity difference over 5 days of treatment was a weighted average of the pain intensity difference from treatment day 2 to treatment day 6, where the weights were calculated as the duration in days between the ith day of treatment and the day of the previous measurement. The lowest possible value that this could have been was -10, which would have indicated an increase in pain by 10 points on average over 5 days of treatment. The highest possible value that this could have been was +10, which would have indicated a decrease in pain by 10 points on average over 5 days of treatment. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox and severe pain (NRS 7-10) at baseline according to assigned treatment arm. | Posted | | Mean | Standard Deviation | score on a scale | | Through 5 days of treatment (i.e., Treatment Day 6) | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
|
|
| Secondary | Mean Time-weighted Average of Pain Intensity Difference Over 14 Days of Treatment | Pain was measured on 11-point numerical rating scale (NRS) where 0 = no pain and 10 = worst possible pain. Pain intensity difference at ith day of treatment (i = 2, ..., 15) calculated as NRS pain score at baseline (last available pre-treatment) minus NRS pain score on ith day of treatment Time-weighted average of pain intensity difference over 14 days of treatment was a weighted average of the pain intensity difference from treatment day 2 to treatment day 15, where the weights were calculated as the duration in days between the ith day of treatment and the day of the previous measurement. The lowest possible value that this could have been was -10, which would have indicated an increase in pain by 10 points on average over 5 days of treatment. The highest possible value that this could have been was +10, which would have indicated a decrease in pain by 10 points on average over 5 days of treatment. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox and severe pain (NRS 7-10) at baseline according to assigned treatment arm. | Posted | | Mean | Standard Deviation | score on a scale | | Through 14 days of treatment (i.e., Treatment Day 15) | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
|
|
| Secondary | Number of Participants Who Developed Severe HMPXV Disease | Severe HMPXV disease was defined as one or more of the following conditions: suspected or confirmed ocular involvement, facial lesions on the malar, nose, or eyelid region, confluent facial lesions, hospitalization due to HMPXV infection or its complications, or lesions that required surgical intervention including debridement, urinary catheterization, or sigmoidoscopy, or extended below the dermis. | Eligible participants with laboratory-confirmed mpox who did not have severe HMPXV disease at baseline according to assigned treatment arm. Participants who had severe HMPXV disease at baseline were enrolled into Arm C. | Posted | | Count of Participants | | Participants | | From study entry through 56 days of follow-up (i.e., Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
|
|
| Secondary | Number of Participants With HMPXV DNA Below Limit of Detection in Skin Lesions | HMPXV DNA was measured as detected or below limit of detection. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants enrolled in-person with laboratory-confirmed mpox according to assigned treatment arm. | Posted | | Count of Participants | | Participants | | Baseline, Days 8, 15, 22, 29, and 57 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
| | OG002 | Open-Label Tecovirimat (Arm C) |
|
| Secondary | Number of Participants With HMPXV DNA Below Limit of Detection in Oropharynx | HMPXV DNA was measured as detected or below limit of detection. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants enrolled in-person with laboratory-confirmed mpox according to assigned treatment arm. | Posted | | Count of Participants | | Participants | | Baseline, Days 8, 15, 22, 29, and 57 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
| | OG002 | Open-Label Tecovirimat (Arm C) | |
|
| Secondary | Number of Participants With HMPXV DNA Below Limit of Detection in Rectum | HMPXV DNA was measured as detected or below limit of detection. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants enrolled in-person with laboratory-confirmed mpox according to assigned treatment arm. | Posted | | Count of Participants | | Participants | | Baseline, Days 8, 15, 22, 29, and 57 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
| | OG002 | Open-Label Tecovirimat (Arm C) | |
|
| Secondary | Number of Participants With HMPXV DNA Below Limit of Detection in Blood | HMPXV DNA measured as detected or below limit of detection. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants enrolled in-person with laboratory-confirmed mpox according to assigned treatment arm. | Posted | | Count of Participants | | Participants | | Baseline, Days 8, 15, 22, 29, and 57 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
| | OG002 | Open-Label Tecovirimat (Arm C) | |
|
| Secondary | Number of Participants With HMPXV DNA Below Limit of Detection in Vaginal Swabs | HMPXV DNA measured as detected or below limit of detection. Includes data from follow-up visits occurring through October 23, 2024. | Female participants enrolled in-person with laboratory-confirmed mpox according to assigned treatment arm. | Posted | | Count of Participants | | Participants | | Baseline, Days 8, 15, 22, 29, and 57 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
| | OG002 | Open-Label Tecovirimat (Arm C) | |
|
| Secondary | Cumulative Proportion With Complete Lesion Healing by Day 29 | Complete lesion healing was defined as all lesions re-epithelialized. The cumulative incidence of complete lesion healing was estimated using the Aalen-Johansen estimator. The treatment effect, i.e., the subdistribution hazard ratio of tecovirimat relative to placebo, was estimated using the Fine and Gray subdistribution proportional hazards model. All-cause death, start of open-label tecovirimat due to disease progression or severe pain, and use of other antivirals with expected activity against mpox were treated as competing events. Follow-up time was censored at last contact. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox and one or more skin or visible mucosal lesions that were able to be followed to resolution according to assigned treatment arm. | Posted | | Number | 95% Confidence Interval | cumulative proportion of participants | | From study entry through 28 days of follow-up (i.e., Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | |
|
| Secondary | Number of Participants With no Missed Doses (of Last Three Prescribed Doses) | Since the adherence assessment was removed from protocol version 3.0, the number of participants with adherence data was expected to be small and no formal statistical comparison between treatment arms was done. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants who took at least one dose of tecovirimat or placebo according to assigned treatment arm. | Posted | | Count of Participants | | Participants | | Days 8 and 15 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
| | OG002 |
|
| Secondary | Median Change From Baseline in EuroQol (EQ) Visual Analogue Scale (VAS) Score | Participants' self-rated health measured on a visual analogue scale (VAS) where 0 = "The worst health you can imagine" and 100 = "The best health you can imagine." Change in EQ VAS score at each timepoint calculated as absolute change from baseline (last available pre-treatment). Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox according to assigned treatment arm. | Posted | | Median | Inter-Quartile Range | score on a scale | | Days 8, 15, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
|
|
| Secondary | Number of Participants Who Reported Each Level of Response on Mobility Dimension of EuroQol EQ-5D-5L Questionnaire | Participants' self-reported health state within mobility dimension of the five-dimension EuroQol EQ-5D-5L questionnaire. Participants were asked to indicate their health state by selecting the most appropriate response level for them from five ordinal response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Results were dichotomized into no problems (level 1) and any problems (levels 2, 3, 4, and 5 combined) for reporting and analysis. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox according to assigned treatment arm. | Posted | | Count of Participants | | Participants | | Baseline, Days 8, 15, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
|
|
| Secondary | Number of Participants Who Reported Each Level of Response on Self-Care Dimension of EuroQol EQ-5D-5L Questionnaire | Participants' self-reported health state within self-care dimension of five-dimension EuroQol EQ-5D-5L questionnaire. Participants were asked to indicate their health state by selecting the most appropriate response level for them from five ordinal response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Results were dichotomized into no problems (level 1) and any problems (levels 2, 3, 4, and 5 combined) for reporting and analysis. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox according to assigned treatment arm. | Posted | | Count of Participants | | Participants | | Baseline, Days 8, 15, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
|
|
| Secondary | Number of Participants Who Reported Each Level of Response on Usual Activities Dimension of EuroQol EQ-5D-5L Questionnaire | Participants' self-reported health state within usual activities dimension of five-dimension EuroQol EQ-5D-5L questionnaire. Participants were asked to indicate their health state by selecting the most appropriate response level for them from five ordinal response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Results were dichotomized into no problems (level 1) and any problems (levels 2, 3, 4, and 5 combined) for reporting and analysis. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox according to assigned treatment arm. | Posted | | Count of Participants | | Participants | | Baseline, Days 8, 15, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
|
|
| Secondary | Number of Participants Who Reported Each Level of Response on Pain/Discomfort Dimension of EuroQol EQ-5D-5L Questionnaire | Participants' self-reported health state within pain/discomfort dimension of five-dimension EuroQol EQ-5D-5L questionnaire. Participants were asked to indicate their health state by selecting the most appropriate response level for them from five ordinal response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Results were dichotomized into no problems (level 1) and any problems (levels 2, 3, 4, and 5 combined) for reporting and analysis. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox according to assigned treatment arm. | Posted | | Count of Participants | | Participants | | Baseline, Days 8, 15, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
|
|
| Secondary | Number of Participants Who Reported Each Level of Response on Anxiety/Depression Dimension of EuroQol EQ-5D-5L Questionnaire | Participants' self-reported health state within anxiety/depression dimension of five-dimension EuroQol EQ-5D-5L questionnaire. Participants were asked to indicate their health state by selecting the most appropriate response level for them from five ordinal response levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5). Results were dichotomized into no problems (level 1) and any problems (levels 2, 3, 4, and 5 combined) for reporting and analysis. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox according to assigned treatment arm. | Posted | | Count of Participants | | Participants | | Baseline, Days 8, 15, and 29 | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
|
|
| Secondary | Proportion of Participants With Grade 3 or Greater Treatment-emergent Adverse Event | Study protocol required reporting of all adverse events (AEs) that (1) led to a change in study treatment regardless of grade, (2) met the serious AE (SAE) or Expedited AE (EAE) reporting requirement, and (3) were Grade 3 or greater. AEs were graded using the DAIDS AE Grading Table (Version 2.1). Severity Grade: 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Life-Threatening, 5 = Death Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants who took at least one dose of tecovirimat or placebo according to initial treatment received. Participants enrolled after October 23, 2024 were excluded. | Posted | | Number | 95% Confidence Interval | proportion of participants | | Through 56 days of follow-up (i.e., Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
|
|
| Secondary | Number of Participants Who Died From Any Cause | Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants according to assigned treatment arm. Participants enrolled after October 23, 2024 were excluded. | Posted | | Count of Participants | | Participants | No | Through 56 days of follow-up (i.e., Day 57) | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
| | OG002 | Open-Label Tecovirimat (Arm C) | Participants assigned to open-label tecovirimat. Tecovirimat Oral Capsule (Open Label):
- Participants weighing <3 kg - Tecovirimat 33.3 mg every 12 hours for 14 days
- Participants weighing 3 kg to less than 6 kg- Tecovirimat 50 mg every 12 hours for 14 days
- Participants weighing 6 kg to less than 13 kg - Tecovirimat 100 mg every 12 hours for 14 days
- Participants weighing 13 kg to less than 25 kg - Tecovirimat 200 mg every 12 hours for 14 days
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
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| Secondary | Tecovirimat Concentrations in Children Less Than 18 Years of Age | Plasma tecovirimat concentrations were quantified using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods. The lower limit of quantification was 5.0 ng/mL. | Measure was not analyzed since only one participant aged <18 years was enrolled and no aggregate results were available for posting. | Posted | | | | | | On Day 8, blood samples were collected pre-dose and at 1, 2, 3, 4, 6, 8, and 10 hours post-dose. On Day 15, a single blood sample was collected within 4 hours of study product administration. | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) | Participants randomized to placebo. Placebo for Tecovirimat:
- Participants weighing 25 kg to less than 40 kg - Placebo for Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Placebo for Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Placebo for Tecovirimat 600 mg every 8 hours for 14 days
| |
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| Other Pre-specified | Cumulative Proportion With Clinical Resolution by Day 29 by Sex | NIH-required analysis. Subgroup analysis of the primary outcome measure by sex. Interaction of treatment and sex was not tested because of the small number of females enrolled. Clinical resolution defined as all skin lesions scabbed, desquamated, or healed, and visible mucosal lesions healed. The cumulative proportion with clinical resolution in the presence of competing events was estimated using the Aalen-Johansen estimator, where all-cause death, start of open-label tecovirimat due to disease progression or severe pain, and use of other antivirals with expected activity against mpox were treated as competing events. Follow-up time was censored at last contact. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox and one or more skin or visible mucosal lesions that were able to be followed to resolution according to assigned treatment arm. | Posted | | Number | 95% Confidence Interval | cumulative proportion of participants | | From study entry through 28 days of follow-up (i.e., Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 | Placebo (Arm B) |
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| Other Pre-specified | Cumulative Proportion With Clinical Resolution by Day 29 by Race | NIH-required analysis. Subgroup analysis of the primary outcome measure by race (White, Non-White). "Non-White" includes participants who identified as Black or African American, Asian, American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, "other" race, having more than one race, or having unknown race. Clinical resolution defined as all skin lesions scabbed, desquamated, or healed, and visible mucosal lesions healed. The cumulative proportion with clinical resolution in the presence of competing events was estimated using the Aalen-Johansen estimator, where all-cause death, start of open-label tecovirimat due to disease progression or severe pain, and use of other antivirals with expected activity against mpox were treated as competing events. Follow-up time was censored at last contact. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox and one or more skin or visible mucosal lesions that were able to be followed to resolution according to assigned treatment arm. | Posted | | Number | 95% Confidence Interval | cumulative proportion of participants | | From study entry through 28 days of follow-up (i.e., Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
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| Other Pre-specified | Cumulative Proportion With Clinical Resolution by Day 29 by Ethnicity | NIH-required analysis. Subgroup analysis of the primary outcome measure by ethnicity (Hispanic or Latino, Not Hispanic or Latino). Clinical resolution defined as all skin lesions scabbed, desquamated, or healed, and visible mucosal lesions healed. The cumulative proportion with clinical resolution in the presence of competing events was estimated using the Aalen-Johansen estimator, where all-cause death, start of open-label tecovirimat due to disease progression or severe pain, and use of other antivirals with expected activity against mpox were treated as competing events. Follow-up time was censored at last contact. Includes data from follow-up visits occurring through October 23, 2024. | Eligible participants with laboratory-confirmed mpox and one or more skin or visible mucosal lesions that were able to be followed to resolution according to assigned treatment arm. Participants who identified as having unknown ethnicity were excluded. | Posted | | Number | 95% Confidence Interval | cumulative proportion of participants | | From study entry through 28 days of follow-up (i.e., Day 29) | | | | ID | Title | Description |
|---|
| OG000 | Tecovirimat (Arm A) | Participants randomized to tecovirimat. Tecovirimat Oral Capsule:
- Participants weighing 25 kg to less than 40 kg - Tecovirimat 400 mg every 12 hours for 14 days
- Participants weighing 40 kg to less than 120 kg - Tecovirimat 600 mg every 12 hours for 14 days
- Participants weighing 120 kg and over - Tecovirimat 600 mg every 8 hours for 14 days
| | OG001 |
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