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| Name | Class |
|---|---|
| Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo | OTHER |
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The purpose of this study is to find out if tecovirimat is a safe and effective drug to treat monkeypox (mpox) in combination with standard of care (SOC). Participants will be randomly assigned to receive oral tecovirimat plus SOC or placebo plus SOC for 14 days.
This is a randomized, placebo-controlled, double-blind study to test the antiviral drug tecovirimat for the treatment of adults and children with laboratory-confirmed monkeypox virus (MPXV) disease at participating sites in the Democratic Republic of Congo. Eligible and consented participants will be randomized 1:1 to receive either oral tecovirimat or placebo, each administered in the hospital with standard-of-care (SOC) treatment for 14 days. Participants will be followed for 28 days with an optional visit at Day 59 for long-term assessment.
If a participant reaches full body lesion resolution but subsequently develops at least one new lesion consistent with mpox after discharge but while still enrolled in the study, they will be eligible to make a sick visit and will be offered standard of care for mpox.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tecovirimat | Experimental | Tecovirimat capsules administered orally to participants for 14 days plus SOC. |
|
| Placebo | Placebo Comparator | Matching placebo capsules administered orally to participants for 14 days plus SOC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecovirimat Oral Capsule | Drug | 200 mg capsules Number of capsules and frequency of dosage will be based on participant weight:
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Lesion Resolution | Number of days from randomization to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed. | Up to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Lesion Resolution for Participants With Symptom Onset Less Than or Equal to 7 Days Before Randomization | Number of days to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed. | up to day 28 |
| Time to Lesion Resolution for Participants With Symptom Onset Greater Than 7 Days Before Randomization |
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This study has no age restriction.
Inclusion Criteria:
Laboratory-confirmed monkeypox virus infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
Monkeypox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
Weight ≥3 kg
Men and non-pregnant women of reproductive potential must agree to use effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. Acceptable methods of contraception include the following:
Stated willingness to comply with all study procedures (including required inpatient stay) and availability for the duration of the study
Ability to provide informed consent personally or by a legally or culturally acceptable representative if the patient is unable to do so
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Jacques Muyembe-Tamfum, MD PhD | Kinshasa University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| L'Hôpital Général de Référence de Kole | Kole | Democratic Republic of the Congo | ||||
| L'Hôpital Général de Référence de Tunda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40239067 | Derived | PALM007 Writing Group; Ali R, Alonga J, Biampata JL, Kombozi Basika M, Maljkovic Berry I, Bisento N, Blum E, Bonnett T, Cone K, Crozier I, Davey R, Dilu A, Dodd LE, Gulati I, Hruby D, Ibanda A, Isse F, Kasareka SS, Kayembe G, Kojan R, Luzolo EK, Lane HC, Lawanga L, Liesenborghs L, Shosongo Lunghe C, Lula Y, Lusakibanza M, Lutete GT, Mbala-Kingebeni P, Miranda A, Mukadi-Bamuleka D, Mukendi G, Lupola PM, Muyembe-Tamfum JJ, Ndungunu R, Nganga B, Ntamabyaliro N, Nussenblatt V, Omulepu I, Omalokoho Onosomba J, Proschan M, Rubenstein K, Saknite I, Schechner A, Shaw-Saliba K, Sivahera B, Smolskis M, Tillman A, Tkaczyk E, Tshimanga C, Tshiani Mbaya O, Tshomba A, Yemba Unda Tshomba F, Vallee D, Vogel S, Weyers S. Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo. N Engl J Med. 2025 Apr 17;392(15):1484-1496. doi: 10.1056/NEJMoa2412439. |
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Patients were recruited from the areas surrounding two sites in rural Democratic Republic of the Congo - Tunda and Kole. Patient recruitment took place from October 2022 through July 9, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tecovirimat | Tecovirimat capsules administered orally to participants for 14 days plus SOC. |
| FG001 | Placebo | Matching placebo capsules administered orally to participants for 14 days plus SOC. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intention-to-treat primary analysis population
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| ID | Title | Description |
|---|---|---|
| BG000 | Tecovirimat | Tecovirimat capsules administered orally to participants for 14 days plus SOC. |
| BG001 | Placebo | Matching placebo capsules administered orally to participants for 14 days plus SOC. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Lesion Resolution | Number of days from randomization to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed. | Intention to treat population | Posted | Median | 95% Confidence Interval | Days | Up to day 28 |
|
From enrollment until the end of follow-up, up to 58 days
All adverse events were documented and recorded and all grade 3 and above adverse events were reported to a study pharmacovigilance committee from the time informed consent was obtained through the end of subject participation in the study. Where possible, adverse events were graded according to the "Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Laboratory values or events not included in CTCAE were graded using tables provided in the study protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tecovirimat | Tecovirimat capsules administered orally to participants for 14 days plus SOC. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lori Dodd | National Institute of Allergy and Infectious Diseases | 2406695247 | doddl@niaid.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2024 | Sep 15, 2025 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Main | Feb 21, 2024 | Sep 15, 2025 | SAP_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Appendix 3 | Jun 27, 2024 | Sep 15, 2025 | SAP_005.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2023 | Dec 3, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D045908 | Mpox, Monkeypox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C505045 | tecovirimat |
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|
|
| Placebo | Drug | Capsules to match tecovirimat |
|
Number of days to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed. |
| up to day 28 |
| Number and Percentage of Participants With Negative Blood PCR Results | Percentage of participants with negative blood sample MPXV PCR results 14 days post-randomization, out of those positive at baseline | day 14 |
| Number and Percentage of Participants With Negative Oropharyngeal Swab PCR Results | Number and percentage of participants with negative oropharyngeal swab MPXV PCR results 14 days post-randomization, out of those positive at baseline | day 14 |
| Number and Percentage of Participants With Negative Lesion Swab PCR Results | Number and and percentage of participants with negative lesion swab MPXV PCR results 14 days post-randomization, of those positive at baseline | day 14 |
| Mortality Within the First 28 Days Post-randomization | Number of deaths post-randomization | up to day 28 |
| Incidence of Non-fatal Serious Adverse Events Requiring Permanent Drug Discontinuation | Number of participants with a non-fatal serious adverse event requiring permanent drug discontinuation through the end of the treatment period (14 days) | Up to day 14 |
| Incidence of Non-fatal Adverse Events Requiring Permanent Drug Discontinuation | Number of participants with a non-fatal adverse event requiring permanent drug discontinuation through the end of the treatment period (14 days) | Up to day 14 |
| Incidence of Adverse Events | Number of participants with an adverse event up to day 28 | up to day 28 |
| Incidence of Bacterial Infection Adverse Events | Number of participants with a bacterial infection adverse event up to day 28 | up to day 28 |
| Tunda |
| Democratic Republic of the Congo |
| Adverse Event |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Days since onset of symptoms | Number of days since patient-reported onset of mpox symptoms | Mean | Standard Deviation | Days |
|
| Less than or equal to 7 days since onset of symptoms | Grouped number of days since patient-reported onset of mpox symptoms | Count of Participants | Participants |
|
| Greater than 7 days since onset of symptoms | Grouped number of days since patient-reported onset of mpox symptoms | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Time to Lesion Resolution for Participants With Symptom Onset Less Than or Equal to 7 Days Before Randomization | Number of days to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed. | Intention to treat population - participants with symptom onset less than or equal to 7 days before randomization | Posted | Median | 95% Confidence Interval | Days | up to day 28 |
|
|
|
| Secondary | Time to Lesion Resolution for Participants With Symptom Onset Greater Than 7 Days Before Randomization | Number of days to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed. | Intention to treat population - participants with symptom onset greater than 7 days before randomization | Posted | Median | 95% Confidence Interval | Days | up to day 28 |
|
|
|
| Secondary | Number and Percentage of Participants With Negative Blood PCR Results | Percentage of participants with negative blood sample MPXV PCR results 14 days post-randomization, out of those positive at baseline | Intention to treat population - participants with positive MPXV PCR in the blood at baseline | Posted | Count of Participants | Participants | day 14 |
|
|
|
| Secondary | Number and Percentage of Participants With Negative Oropharyngeal Swab PCR Results | Number and percentage of participants with negative oropharyngeal swab MPXV PCR results 14 days post-randomization, out of those positive at baseline | Intention to treat population - participants with positive oropharyngeal swab MPXV PCR results at baseline | Posted | Count of Participants | Participants | day 14 |
|
|
|
| Secondary | Number and Percentage of Participants With Negative Lesion Swab PCR Results | Number and and percentage of participants with negative lesion swab MPXV PCR results 14 days post-randomization, of those positive at baseline | Intention to treat population - participants with positive lesion swab MPXV PCR results at baseline | Posted | Count of Participants | Participants | day 14 |
|
|
|
| Secondary | Mortality Within the First 28 Days Post-randomization | Number of deaths post-randomization | Intention to treat population | Posted | Count of Participants | Participants | up to day 28 |
|
|
|
| Secondary | Incidence of Non-fatal Serious Adverse Events Requiring Permanent Drug Discontinuation | Number of participants with a non-fatal serious adverse event requiring permanent drug discontinuation through the end of the treatment period (14 days) | As-treated population | Posted | Count of Participants | Participants | Up to day 14 |
|
|
|
| Secondary | Incidence of Non-fatal Adverse Events Requiring Permanent Drug Discontinuation | Number of participants with a non-fatal adverse event requiring permanent drug discontinuation through the end of the treatment period (14 days) | As-treated population | Posted | Count of Participants | Participants | Up to day 14 |
|
|
|
| Secondary | Incidence of Adverse Events | Number of participants with an adverse event up to day 28 | As-treated population | Posted | Count of Participants | Participants | up to day 28 |
|
|
|
| Secondary | Incidence of Bacterial Infection Adverse Events | Number of participants with a bacterial infection adverse event up to day 28 | As-treated population | Posted | Count of Participants | Participants | up to day 28 |
|
|
|
| 5 |
| 295 |
| 15 |
| 295 |
| 214 |
| 295 |
| EG001 | Placebo | Matching placebo capsules administered orally to participants for 14 days plus SOC. | 5 | 302 | 15 | 302 | 211 | 302 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Complicated malaria | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Endometritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Keratitis viral | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Peritonitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
|
| Abortion early | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Systematic Assessment |
|
| Abortion spontaneous incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Systematic Assessment |
|
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA 25.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypovolaemic shock | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Shock | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
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| D018419 |
| Primate Diseases |
| D000820 | Animal Diseases |
| D012376 | Rodent Diseases |