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MonkeypoxPhase 4EPOXINCT06156566

European Trial Into Mpox Infection

A Phase 4 study testing Tecovirimat Oral Capsule in people with Monkeypox, run by Miquel Ekkelenkamp at 12 sites in 8 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The goal of this randomized controlled double-blind clinical trial is to test the drug tecovirimat in patients with mpox (previously known as monkeypox) disease. The main questions it aims to answer are: Is tecovirimat effective in treating mpox infection. Is tecovirimat safe to treat patients with mpox infection. Read more about this study

Who is it for?
Ages 18 years and older
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
150 participants
Where
12 sitesin 8 countries
Study dates
9 Aug 2024to Aug 2026
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Polymerase Chain Reaction (PCR) /Nucleic Acid Amplification Test (NAAT) -confirmed mpox infection
  • The presence of active skin or mucosal lesion(s)
  • Signed Informed Consent Form

Who cannot join

  • Age <18 years.
  • Body weight <40 kg
  • Pregnant and breastfeeding patients are not eligible for inclusion in this study.
  • Lack of mental capacity to provide informed consent
  • Trial participation is considered not in the best interest of patient
  • Known hypersensitivity to the active substance or to any of the excipients of the study drug.
Show all 11Show fewer
  • Use of contraindicated treatment repaglinide. (Repaglinide, an oral treatment for diabetes mellitus, may be discontinued while taking study treatment with the agreement of the patient's general practitioner, who may start alternate diabetes treatment if considered necessary.)
  • Previous, current or planned use of another investigational drug (tecovirimat) at any point during study participation.
  • The patient's own doctor considers there to be a definite indication for the patient to receive tecovirimat or the local guidelines establish that tecovirimat treatment should be initiated
  • The patient's own doctor considers there to be a definite contraindication to the patient receiving tecovirimat.
  • The patient suffers from hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

Trial locations and contacts

12 sites in 8 countries.

Miquel B Ekkelenkamp, MD, PhD contact

+31643217087

m.ekkelenkamp@umcutrecht.nl

Lina Gurskaite contact

+31631117890

lina.gurskaite@ecraid.eu

12 sites in 8 countries

Spain3 sites, 3 recruiting

  • Hospital Clinico San Carlos

    Madrid, 28040

    Vicente Estrada

    Vicente Estrada

    Not yet recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Jose I Bernardino

    Jose I Bernardino

    Not yet recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Miguel Nicolas Navarrete Lorite, Dr

    Miguel Nicolas Navarrete Lorite, Dr

    Not yet recruiting

Other trials in Spain

Belgium2 sites, 2 recruiting

  • Institute of Tropical Medicine

    Antwerp, Antwerp, 2000

    Laurens Liesenborghs, MD

    Laurens Liesenborghs, MD

    Recruiting

  • Cliniques Universitaires St. Luc

    Brussels, 1200

    Leila Belkhir, Prof

    Leila Belkhir, Prof

    Not yet recruiting

Other trials in Belgium

Italy2 sites, 2 recruiting

  • Hospital Luigi Sacco

    Milan

    Giuliano Rizzardini

    Giuliano Rizzardini

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Integrata Verona - AOUI Verona

    Verona

    Evelina Tacconelli

    Evelina Tacconelli

    Not yet recruiting

Other trials in Italy

France1 site, 1 recruiting

  • APHP St. Louis

    Paris, 75010

    Jean Michel Molina, Prof

    Jean Michel Molina, Prof

    Not yet recruiting

Other trials in France

Germany1 site, 1 recruiting

  • Universitätsklinikum Bonn

    Bonn, 53127

    Christoph Boesecke

    Christoph Boesecke

    Not yet recruiting

Other trials in Germany

Netherlands1 site, 1 recruiting

  • Amsterdam UMC - AMC

    Amsterdam

    Abraham Goorhuis

    Abraham Goorhuis

    Not yet recruiting

Other trials in Netherlands

Norway1 site, 1 recruiting

  • Oslo Unversity Hospital

    Oslo, 0450

    Frank Olav Dahler Pettersen, Dr

    Frank Olav Dahler Pettersen, Dr

    Not yet recruiting

Other trials in Norway

Portugal1 site, 1 recruiting

  • Hospital de Santo António dos Capuchos

    Lisbon, 1169-050

    Cândida Fernandes, MD

    Cândida Fernandes, MD

    Not yet recruiting

Other trials in Portugal

About this study

Official title: European Randomised Clinical Trial on mPOX Infection

The goal of this randomized controlled double-blind clinical trial is to test the drug tecovirimat in patients with mpox (previously known as monkeypox) disease.

The main questions it aims to answer are:

  • Is tecovirimat effective in treating mpox infection.
  • Is tecovirimat safe to treat patients with mpox infection.

Participants will receive either the drug tecovirimat orally, 600 mg twice per day, or a matching placebo. The outcome of the infection and the side effect experienced will be compared between the two groups.

Conditions
Monkeypox
Being tested
Tecovirimat Oral Capsule, Placebo
Keywords
tecovirimat, mpox, TPOXX
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 Tecovirimat

    600 mg, twice daily, 14 days.

  • PlaceboDrug

    Also called Oral placebo capsule

    3 capsules, twice daily, 14 days.

Study groups in NCT06156566
Study groupRoleWhat they receive
TecovirimatActive comparatorOral treatment with tecovirimat 200 mg capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).
Receives: Drug: Tecovirimat Oral Capsule
PlaceboPlacebo comparatorMatching placebo to tecovirimat capsules. Twice daily three capsules orally. Duration of treatment: 14 days (28 administrations).
Receives: Drug: Placebo

What is being measured

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

  1. Time to complete mpox lesion resolution

    Time in days until day 28 after randomization, until the first day on which all lesions are completely healed with a new fresh layer of skin.

    Measured: 28 days

Secondary outcomes (10)

  1. Time to active lesion resolution

    The first day on which all skin lesions are scabbed or desquamated (and mucosal lesions healed), counted from start of therapy, with follow-up up to 28 days after randomisation

    Measured: 28 days

  2. Status of the lesions on day 7, 14 and 28

    Status of the lesions on day 7, 14, 21 and 28 according to an ordinal scale. The ordinal scale is a) all lesions completely resolved (all scabs dropped off and intact skin remains underneath, and all mucosal lesions healed), b) active lesions resolved (all skin lesions scabbed or desquamated, but not fully resolved), c) active lesions persist but no new lesions in last 24 hours, d) new lesion(s) in last 24 hours.

    Measured: Day 7, day 14 and day 28

  3. Time to resolution of symptoms

    Time to resolution of symptoms. Symptoms are counted from start of therapy and assessed by self-assessment. These include fatigue, malaise, nausea, vomiting, abdominal pain, anorexia, cough, dysphagia, odynophagia, fever, headache, oral pain, pain with urination, rectal/anal pain. Signs will be evaluated at study visits only, including lymphadenopathy and proctitis, and are not included in the evaluation of symptoms.

    Measured: 90 days

  4. Occurrence of a negative monkeypox PCR of skin or mucosal swab

    Negative monkeypox PCR (Polymerase Chain Reaction) of skin or mucosal swab, assessed for the two most active skin lesions or for the mucosal lesion.

    Measured: Days 7, 14 and 28

  5. Persistence of scars and skin discoloration

    Assessment of scars and/or skin discoloration of mpox lesions.

    Measured: Assessed on day 90

  6. Change from baseline in quality of life

    Change from baseline of quality of life, assessed by the Dermatology Life Quality Index (DLQI).

    Minimum value = 0, maximum value = 30, a higher score indicates a worse outcome. (Ten questions with each a minimum of 0 and a maximum of 3.)

    Measured: Assessed on day 14 and day 90.

  7. All-cause mortality

    All-cause mortality

    Measured: Assessed on day 28 and on day 90

  8. Time to complication or all-cause admission to hospital or all-cause death

    Time to complication or all-cause admission to hospital or all-cause death, within 28 days and within 90 days, applicable to outpatients only, and counted from start of therapy. A complication includes genitourinary complications (e.g. urinary retention, paraphimosis), lower respiratory tract complication (e.g. pneumonia and need for oxygen), ocular impairment (e.g. keratitis), neurologic impairment (e.g. encephalitis) or mental health disturbance (e.g. confusion), cardiac impairment (e.g. cardiomyopathy or myocarditis), severe dehydration needing admission, secondary bacterial skin infection or severe pain needing hospital admission.

    Measured: Assessed within 28 days and within 90 days.

  9. Frequency of AEs, SAEs and SUSARs

    Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reaction (SUSARs) for the specific therapeutic, within the first 28 days, but also assessed during the total follow-up (up to day 90).

    Measured: Assessed within 28 days and within 90 days.

  10. Resolution of pain

    Resolution of pain, by measuring:

    1. time to resolution of pain assessed by the Numeric Rating Scale (NRS) for pain,
    2. time to cessation of the use of analgesic medication, defined as time to consistently reporting no use of analgesia for mpox-related lesions, up to 90 days after randomisation.
    3. anal pain on days 7, 14, and 90 assessed by the Health Related Symptom Index.

    Measured: Assessed on days 7, 14 and 90.

Timeline

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

  1. First posted5 Dec 2023
  2. Study start9 Aug 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionAug 2026 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06156566
Sponsor's protocol ID
2022-501979-10
Acronym
EPOXI
Status last verified
Aug 2024
First submitted
25 Oct 2023
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Adler H, Gould S, Hine P, Snell LB, Wong W, Houlihan CF, Osborne JC, Rampling T, Beadsworth MB, Duncan CJ, Dunning J, Fletcher TE, Hunter ER, Jacobs M, Khoo SH, Newsholme W, Porter D, Porter RJ, Ratcliffe L, Schmid ML, Semple MG, Tunbridge AJ, Wingfield T, Price NM; NHS England High Consequence Infectious Diseases (Airborne) Network. Clinical features and management of human monkeypox: a retrospective observational study in the UK. Lancet Infect Dis. 2022 Aug;22(8):1153-1162. doi: 10.1016/S1473-3099(22)00228-6. Epub 2022 May 24.

    PubMed 35623380

  • Benites-Zapata VA, Ulloque-Badaracco JR, Alarcon-Braga EA, Hernandez-Bustamante EA, Mosquera-Rojas MD, Bonilla-Aldana DK, Rodriguez-Morales AJ. Clinical features, hospitalisation and deaths associated with monkeypox: a systematic review and meta-analysis. Ann Clin Microbiol Antimicrob. 2022 Aug 10;21(1):36. doi: 10.1186/s12941-022-00527-1.

    PubMed 35948973

  • Benjamini Y, Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J R Statist Soc B 1995;57(1):289-300.

  • Bunge EM, Hoet B, Chen L, Lienert F, Weidenthaler H, Baer LR, Steffen R. The changing epidemiology of human monkeypox-A potential threat? A systematic review. PLoS Negl Trop Dis. 2022 Feb 11;16(2):e0010141. doi: 10.1371/journal.pntd.0010141. eCollection 2022 Feb.

    PubMed 35148313

  • Burkhalter JE, Atkinson TM, Berry-Lawhorn J, Goldstone S, Einstein MH, Wilkin TJ, Lee J, Cella D, Palefsky JM; ANCHOR HRQOL Implementation Group. Initial Development and Content Validation of a Health-Related Symptom Index for Persons either Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions. Value Health. 2018 Aug;21(8):984-992. doi: 10.1016/j.jval.2018.01.018. Epub 2018 Apr 11.

    PubMed 30098677

  • Delaune D, Iseni F. Drug Development against Smallpox: Present and Future. Antimicrob Agents Chemother. 2020 Mar 24;64(4):e01683-19. doi: 10.1128/AAC.01683-19. Print 2020 Mar 24.

    PubMed 31932370

  • EMA: An overview of Tecovirimat SIGA and why it is authorised in the EU. 31-May-2022: https://www.ema.europa.eu/en/documents/overview/tecovirimat-siga-epar-medicine-overview_en.pdf

  • EMA: Summary of product characteristics: www.ema.europa.eu/en/documents/product-information/tecovirimat-siga-epar-product-information_en.pdf, accessed 6-9-2022

  • Grosenbach DW, Honeychurch K, Rose EA, Chinsangaram J, Frimm A, Maiti B, Lovejoy C, Meara I, Long P, Hruby DE. Oral Tecovirimat for the Treatment of Smallpox. N Engl J Med. 2018 Jul 5;379(1):44-53. doi: 10.1056/NEJMoa1705688.

    PubMed 29972742

  • Hendrickson RC, Wang C, Hatcher EL, Lefkowitz EJ. Orthopoxvirus genome evolution: the role of gene loss. Viruses. 2010 Sep;2(9):1933-1967. doi: 10.3390/v2091933. Epub 2010 Sep 15.

    PubMed 21994715

  • Hoy SM. Tecovirimat: First Global Approval. Drugs. 2018 Sep;78(13):1377-1382. doi: 10.1007/s40265-018-0967-6.

    PubMed 30120738

  • Howard G, Waller JL, Voeks JH, Howard VJ, Jauch EC, Lees KR, Nichols FT, Rahlfs VW, Hess DC. A simple, assumption-free, and clinically interpretable approach for analysis of modified Rankin outcomes. Stroke. 2012 Mar;43(3):664-9. doi: 10.1161/STROKEAHA.111.632935. Epub 2012 Feb 16.

    PubMed 22343650

  • Jezek Z, Nakano JH, Arita I, Mutombo M, Szczeniowski M, Dunn C. Serological survey for human monkeypox infections in a selected population in Zaire. J Trop Med Hyg. 1987 Feb;90(1):31-8.

    PubMed 3029395

  • Joint ECDC-WHO Regional Office for Europe Monkeypox Surveillance Bulletin, published 31-8-2022: monkeypoxreport.ecdc.europa.eu, accessed 6-9-2022

  • Jordan R, Goff A, Frimm A, Corrado ML, Hensley LE, Byrd CM, Mucker E, Shamblin J, Bolken TC, Wlazlowski C, Johnson W, Chapman J, Twenhafel N, Tyavanagimatt S, Amantana A, Chinsangaram J, Hruby DE, Huggins J. ST-246 antiviral efficacy in a nonhuman primate monkeypox model: determination of the minimal effective dose and human dose justification. Antimicrob Agents Chemother. 2009 May;53(5):1817-22. doi: 10.1128/AAC.01596-08. Epub 2009 Feb 17.

    PubMed 19223621

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tecovirimat Oral Capsule in people with Monkeypox, run by Miquel Ekkelenkamp at 12 sites in 8 countries.

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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Spain, Belgium, Italy, France, Germany and 3 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Miquel B Ekkelenkamp, MD, PhD (+31643217087, m.ekkelenkamp@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to complete mpox lesion resolution (time frame: 28 days). 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 NCT06156566, which also lists 31 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 28 Mar 2025.

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