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MonkeypoxPhase 2NCT05559099

Tecovirimat for Treatment of Monkeypox Virus

A Phase 2 study testing Tecovirimat Oral Capsule in people with Monkeypox, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in Democratic Republic of the Congo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Monkeypox
What is being tested?
Tecovirimat Oral Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
597 participants
Where
2 sitesDemocratic Republic of the Congo
Study dates
10 Oct 2022to 3 Sep 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • 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:
  • Hormonal contraception
  • Male or female condom
Show all 10Show fewer
  • Diaphragm or cervical cap with a spermicide
  • Intrauterine device
  • 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

Who cannot join

  • Current or planned use of a meglitinide (repaglinide, nateglinide)
  • Planned use of midazolam while on study drug
  • Severe anemia, defined as hemoglobin <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
  • Participants who are unable to safely swallow oral medications, such as those who are at risk of aspiration

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

Other trials in Democratic Republic of the Congo

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

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.

Read the detailed description

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.

Conditions
Monkeypox
Being tested
Tecovirimat Oral Capsule, Placebo
Keywords
Monkeypox, MPXV
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 CapsuleDrug

    Also called TPOXX

    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)

  • PlaceboDrug

    Capsules to match tecovirimat

Study groups in NCT05559099
Study groupRoleWhat they receive
TecovirimatExperimentalTecovirimat capsules administered orally to participants for 14 days plus SOC.
Receives: Drug: Tecovirimat Oral Capsule
PlaceboPlacebo comparatorMatching placebo capsules administered orally to participants for 14 days plus SOC.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to day 28

Secondary outcomes (10)

  1. 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.

    Measured: up to day 28

  2. 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.

    Measured: up to day 28

  3. 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

    Measured: day 14

  4. 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

    Measured: day 14

  5. 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

    Measured: day 14

  6. Mortality Within the First 28 Days Post-randomization

    Number of deaths post-randomization

    Measured: up to day 28

  7. 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)

    Measured: Up to day 14

  8. 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)

    Measured: Up to day 14

  9. Incidence of Adverse Events

    Number of participants with an adverse event up to day 28

    Measured: up to day 28

  10. Incidence of Bacterial Infection Adverse Events

    Number of participants with a bacterial infection adverse event up to day 28

    Measured: up to day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start10 Oct 2022
  3. Primary completion3 Sep 2024
  4. Study completion3 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
597 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05559099
Sponsor's protocol ID
PALM 007
Status last verified
Sep 2025
First submitted
23 Sep 2022
Last updated
9 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Saknite I, Mutombo Lupola P, McNeil AJ, Kasereka Sivasingana S, Tshilombo Mwindila JM, Malamba Lohalo E, Divine Tshi-Manina O, Lodi Ndjovu F, Tshimanga C, Matiba Ngalumono B, Alonga Etshindo M, Djese Logombe R, Diphanga Mbambi G, Nzengu Mukanya G, Mukendi GA, Amani Songa F, Kasangi Kitenge O, Ndjekembo Djamba M, Mayaka Oyeka J, Lonza Lotepa H, Ibemba Alanda S, Lukala Ngereza C, Okamba Denga M, Ndeke Ndongo C, Margot Makuenda E, Oleko Yemba J, Takoy Ndjeka D, Luhata Mukindji J, Kombozi Basika M, Bitilembo Bitilembo J, Aridja Kayembe A, Mara Kisaka M, Chikesa Vangu G, Kayembe Mpinga G, Dilu Phanzu A, Nganga Mbutu B, Ali Ekangu R, Oloma Tshomba A, Silaphet T, Weiss R, Jiang B, Zonveni Be Lombe A, Cowen EW, Crozier I, Dawant BM, Dodd LE, Davey R, Lane HC, Muyembe-Tamfum JJ, Biampata Mutumukole JL, Nussenblatt V, Tshiani Mbaya O, Mbala Kingebeni P, Tkaczyk ER. Total body photography for standardised documentation of mpox skin lesions in remote study sites in the Democratic Republic of the Congo. BMJ Glob Health. 2026 Jul 30;11(7):e020904. doi: 10.1136/bmjgh-2025-020904.

    PubMed 42532635

  • 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.

    PubMed 40239067

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tecovirimat Oral Capsule in people with 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 10 inclusion and 6 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 9 Oct 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

On the ClinicalTrials.gov record for NCT05559099, which also lists 2 linked publications.

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 9 Oct 2025.

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