Mpox (Monkeypox)NCT06721585
Tecovirimat for Treatment of Monkeypox Virus - Study Extension Providing Standard of Care Only
An observational study of Mpox (Monkeypox), run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Democratic Republic of the Congo.
Trial summary
The purpose of the PALM007 extension is to further characterize the clinical and natural history of mpox, and to provide standard of care (SOC) during the ongoing outbreaks. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mpox (Monkeypox)
- What is being tested?
- Tecovirimat Oral Capsule [Tpoxx]
- Type of treatment
- Pill or oral medicine
- How many people
- 328 participants
- Where
- 2 sitesDemocratic Republic of the Congo
- Study dates
- 10 Jul 2024to 30 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and children with laboratory-confirmed monkeypox virus (MPXV) disease at participating sites in the Democratic Republic of Congo
Who may be able to join
- Laboratory-confirmed mpox infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
- Mpox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
- 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
- Severe disease, defined as the presence of at least one of the following:
- Flat lesions (flat and soft lesions; no pustules or vesicles visible to the eye)
Show all 21Show fewer
- Pregnancy (due to risk of serious complication)
- Suspected sickle cell disease
- Severe clinical disease, defined as having at least 3 of the following:
- Lesion count greater than 250
- Fever for greater than 48 hours
- Hypotension (systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 60 mmHg)
- Pallor
- Respiratory distress
- Altered mental status
- Extreme lethargy
- Painful oral lesions making oral intake difficult
- Difficulty peeing or pooping due to painful lesions
- Painful lesions on hands and feet
- Tachycardia (heart rate greater than 100 beats per minute)
- Diarrhea (greater than or equal to 3 liquid stools per 24 hours)
Who cannot join
- Severe anemia, defined as hemoglobin less than 7 g/dL
- Current or planned use of another investigational drug at any point during study participation
- Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study
Trial locations and contacts
2 sites in 1 country.
Democratic Republic of the Congo2 sites
L'Hôpital Général de Référence de Kole
Kole
L'Hôpital Général de Référence de Tunda
Tunda
About this study
Official title: A Randomized, Placebo-controlled, Double-blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Adult and Pediatric Patients With Monkeypox Virus Disease - Extension Amendment
The purpose of the PALM007 extension is to further characterize the clinical and natural history of mpox, and to provide standard of care (SOC) during the ongoing outbreaks.
Read the detailed description
This open-label extension to the PALM007 protocol began in July 2024 after enrollment into the main study ended. It will further clinically characterize the natural history of mpox, and continue to identify recrudescent cases. Participants were initially provided SOC as well as open-access tecovirimat. The results of PALM007 were unblinded in August 2024, and although no safety concerns were observed with tecovirimat use, efficacy, defined by improvement in days to complete mpox skin lesion resolution, was not observed for tecovirimat compared to placebo. Therefore, the administration of tecovirimat in the extension amendment was discontinued in early August 2024, once these results were known, and only SOC continues to be provided.
Participants are admitted to the hospital and receive SOC for mpox until they have recovered. Recovery is defined as resolution of all lesions and a negative blood test for MPXV. Participants will remain on study through day 59 but will not have a scheduled study visit unless they present with new mpox symptoms. Sick visits will be available for participants who reach full body lesion resolution but subsequently develop at least 1 new lesion consistent with mpox after discharge and on or before day 59, at which time viral PCR and clinical laboratory testing will be performed and participants will be offered standard of care.
Initially, all participants presenting with mpox were eligible to enroll in this extension, regardless of disease severity. As of 05May2025, only patients with severe disease, defined as the presence of any of the following: flat lesions, pregnancy (due to risk for serious complications), suspected sickle cell disease, or severe clinical disease will be enrolled.
- Conditions
- Mpox (Monkeypox)
- Being tested
- Tecovirimat Oral Capsule [Tpoxx], Standard of Care (SOC)
- Keywords
- Mpox, MPXV, Monkeypox
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tecovirimat Oral Capsule [Tpoxx]Drug
Also called TPOXX
Tecovirimat Oral Capsule 200 mg capsules
Number of capsules and frequency of dosage will be based on participant weight:
- ≥120 kg: three capsules three times a day (total daily tecovirimat dose: 1,800 mg)
- 40 to <120 kg: three capsules twice a day (total daily tecovirimat dose: 1,200 mg)
- 25 to <40 kg: two capsules twice a day (total daily tecovirimat dose: 800 mg)
- 13 to <25 kg: one capsule twice a day (total daily tecovirimat dose: 400 mg)
- 6 to <13 kg: ½ the contents of a capsule twice daily (total daily tecovirimat dose: 200 mg)
- 3 to <6 kg: ¼ the contents of a capsule twice daily (total daily tecovirimat dose: 100 mg)
Standard of Care (SOC)Other
Participants are provided SOC for mpox
| Study group | Role | What they receive |
|---|---|---|
| Open-access tecovirimat plus SOC for mpox | Participants are provided SOC as well as open-access tecovirimat. Tecovirimat capsules are administered orally to participants for 14 days based on participant weight.
Closed to new participants in August 2024. Receives: Drug: Tecovirimat Oral Capsule [Tpoxx]; Other: Standard of Care (SOC) | |
| Standard of care for mpox | Participants are provided SOC for mpox. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to lesion resolution
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.
Measured: up to day 28
Secondary outcomes (7)
Time to lesion resolution for participants with symptom onset less than or equal to 7 days enrollment
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.
Measured: up to day 28
Time to lesion resolution for participants with symptom onset greater than 7 days before enrollment
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.
Measured: up to day 28
Number of participants that develop at least 1 new mpox lesion after discharge
Number of participants who reach full body lesion resolution, and develop at least 1 new lesion after discharge
Measured: up to day 59
Mortality within the first 28 days post-enrollment
Number of deaths post-enrollment
Measured: up to day 28
Number of days to participant death
Number of days post-enrollment
Measured: up to day 59
Frequency of solicited clinical symptoms
Clinical symptoms defined as: nausea, vomiting, abdominal pain, diarrhea, anorexia, cough, lymphadenopathy, dysphagia, sore throat, muscle aches, fatigue/lack of energy, fever, chills, night sweats, headache, ocular lesions, eye pain, change in vision, buccal ulcers, nasal congestion, cough, joint pain, pain with urination, painful skin lesions, pruritic skin lesions.
Measured: up to day 59
Duration of solicited clinical symptoms
Number of days
Measured: up to day 59
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start10 Jul 2024
- Primary completion30 Jul 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mpox (Monkeypox)Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Institut National de Recherche Biomedicale (INRB)
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques Muyembe-Tamfum, MD PhD, Principal investigator, Kinshasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721585
- Sponsor's protocol ID
- PALM007-Ext
- Status last verified
- Sep 2025
- First submitted
- 3 Dec 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Adult and Pediatric Patients With Monkeypox Virus Disease - Extension Amendment
- ClinicalTrials.gov ID
- NCT06721585
- Acronym / sponsor ID
- PALM007-Ext
- Conditions
- Mpox (Monkeypox)
- Keywords
- Mpox, MPXV, Monkeypox
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Institut National de Recherche Biomedicale (INRB)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the PALM007 extension is to further characterize the clinical and natural history of mpox, and to provide standard of care (SOC) during the ongoing outbreaks.
Detailed description
This open-label extension to the PALM007 protocol began in July 2024 after enrollment into the main study ended. It will further clinically characterize the natural history of mpox, and continue to identify recrudescent cases. Participants were initially provided SOC as well as open-access tecovirimat. The results of PALM007 were unblinded in August 2024, and although no safety concerns were observed with tecovirimat use, efficacy, defined by improvement in days to complete mpox skin lesion resolution, was not observed for tecovirimat compared to placebo. Therefore, the administration of tecovirimat in the extension amendment was discontinued in early August 2024, once these results were known, and only SOC continues to be provided.
Participants are admitted to the hospital and receive SOC for mpox until they have recovered. Recovery is defined as resolution of all lesions and a negative blood test for MPXV. Participants will remain on study through day 59 but will not have a scheduled study visit unless they present with new mpox symptoms. Sick visits will be available for participants who reach full body lesion resolution but subsequently develop at least 1 new lesion consistent with mpox after discharge and on or before day 59, at which time viral PCR and clinical laboratory testing will be performed and participants will be offered standard of care.
Initially, all participants presenting with mpox were eligible to enroll in this extension, regardless of disease severity. As of 05May2025, only patients with severe disease, defined as the presence of any of the following: flat lesions, pregnancy (due to risk for serious complications), suspected sickle cell disease, or severe clinical disease will be enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open-access tecovirimat plus SOC for mpox | – | Drug: Tecovirimat Oral Capsule [Tpoxx], Other: Standard of Care (SOC)Participants are provided SOC as well as open-access tecovirimat. Tecovirimat capsules are administered orally to participants for 14 days based on participant weight. Closed to new participants in August 2024. |
| Standard of care for mpox | – | Other: Standard of Care (SOC)Participants are provided SOC for mpox. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children with laboratory-confirmed monkeypox virus (MPXV) disease at participating sites in the Democratic Republic of Congo
Key inclusion criteria (21 listed)
- Laboratory-confirmed mpox infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
- Mpox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
- 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
- Severe disease, defined as the presence of at least one of the following:
Key exclusion criteria (3 listed)
- Severe anemia, defined as hemoglobin less than 7 g/dL
- Current or planned use of another investigational drug at any point during study participation
- Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tecovirimat Oral Capsule [Tpoxx]Also: TPOXXTecovirimat Oral Capsule 200 mg capsules Number of capsules and frequency of dosage will be based on participant weight: * ≥120 kg: three capsules three times a day (total daily tecovirimat dose: 1,800 mg) * 40 to <120 kg: three capsules twice a day (total daily tecovirimat dose: 1,200 mg) * 25 to <40 kg: two capsules twice a day (total daily tecovirimat dose: 800 mg) * 13 to <25 kg: one capsule twice a day (total daily tecovirimat dose: 400 mg) * 6 to <13 kg: ½ the contents of a capsule twice daily (total daily tecovirimat dose: 200 mg) * 3 to <6 kg: ¼ the contents of a capsule twice daily (total daily tecovirimat dose: 100 mg) | Drug | Open-access tecovirimat plus SOC for mpox |
| Standard of Care (SOC)Participants are provided SOC for mpox | Other | Open-access tecovirimat plus SOC for mpox, Standard of care for mpox |
Primary outcome
Time to lesion resolution
Time frame: up to day 28
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.
7 secondary outcomes
Time to lesion resolution for participants with symptom onset less than or equal to 7 days enrollment
Time frame: up to day 28
Time to lesion resolution for participants with symptom onset greater than 7 days before enrollment
Time frame: up to day 28
Number of participants that develop at least 1 new mpox lesion after discharge
Time frame: up to day 59
Mortality within the first 28 days post-enrollment
Time frame: up to day 28
Number of days to participant death
Time frame: up to day 59
Frequency of solicited clinical symptoms
Time frame: up to day 59
Duration of solicited clinical symptoms
Time frame: up to day 59
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- PALM 007 Record NCT05559099Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Jacques Muyembe-Tamfum, MD PhD principal investigator
Kinshasa University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mpox (Monkeypox), run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to lesion resolution (time frame: up to day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.