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Study on Tecovirimat for Treating Monkeypox in Patients with Confirmed Infection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the disease known as monkeypox, which is a viral infection that can cause skin and mucosal lesions. The trial will evaluate the effectiveness of a treatment using a medication called tecovirimat, which is taken in the form of 200 mg hard capsules. Participants in the study will be divided into two groups: one group will receive the tecovirimat treatment, while the other group will receive a placebo, which looks like the tecovirimat capsules but does not contain the active substance.

The purpose of the study is to gather evidence on how well the treatment works by observing the time it takes for the skin and mucosal lesions to heal completely. The study will follow participants over a period of time to monitor the healing process of their lesions. Participants will be assessed at various points, including days 7, 14, 21, and 28, to check the status of their lesions and any symptoms they may experience, such as fatigue, nausea, or pain. The study will also look at the quality of life of participants and any changes they experience during the trial.

Throughout the study, the occurrence of a negative test for monkeypox will be checked, and any scars or skin discoloration will be assessed. The trial will also monitor for any complications, hospital admissions, or deaths that may occur. The study aims to provide valuable information on the effectiveness of tecovirimat in treating monkeypox and improving the quality of life for those affected by the disease.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient will be required to provide a signed informed consent. This confirms understanding and agreement to participate in the study.

    Eligibility is confirmed through a PCR/NAAT test that verifies a monkeypox infection and the presence of active skin or mucosal lesions.

  2. Step 2

    Randomization

    The patient will be randomly assigned to either the treatment group or the control group. This process is called randomization and ensures that each participant has an equal chance of receiving the tecovirimat treatment or a placebo.

  3. Step 3

    Medication administration

    If assigned to the treatment group, the patient will receive tecovirimat SIGA 200 mg hard capsules. The medication is taken orally.

    The dosage and frequency of administration will be provided by the study team and must be followed as instructed.

  4. Step 4

    Monitoring and assessments

    The patient's progress will be monitored through regular assessments. These include checking the status of lesions on days 7, 14, 21, and 28.

    The primary goal is to observe the time it takes for all lesions to completely heal, which is assessed at day 28.

  5. Step 5

    Symptom tracking

    The patient will self-assess symptoms such as fatigue, nausea, and fever. These symptoms will be tracked throughout the trial.

    The occurrence of a negative monkeypox PCR test will be checked on days 7, 14, and 28.

  6. Step 6

    Quality of life evaluation

    The patient's quality of life will be evaluated using the Dermatology Quality of Life Index on days 7, 14, 28, and 90.

    This assessment helps understand the impact of the treatment on daily life.

  7. Step 7

    Final assessments

    On day 90, the persistence of scars and skin discoloration will be assessed.

    The study will also evaluate any adverse events or serious adverse events that may have occurred during the trial.

Who can join the trial?

5 criteria

  • Must have a PCR/NAAT-confirmed mPOX infection. PCR/NAAT are types of tests that confirm the presence of the virus.
  • Must have active skin or mucosal lesion(s). These are areas on the skin or inside the mouth or nose that are affected by the infection.
  • Must provide signed informed consent. This means you agree to participate in the study after being informed about it.
  • Open to both males and females.
  • Participants must be within the specified age range, which includes both adults and children.

Who cannot join the trial?

3 criteria

  • Patients who do not have a confirmed diagnosis of Monkeypox cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to vulnerable populations, such as those with certain health conditions that make them more at risk, cannot participate.
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Investigated drugs

mPOX Treatment is a medication being tested in this clinical trial. It is designed to help treat infections caused by the mPOX virus. The goal of this treatment is to help clear up skin and mucosal lesions, which are common symptoms of the infection. By using this medication, researchers hope to find out if it can speed up the healing process for patients with mPOX.

What is already known about the treatment

  • Tecovirimat

    Tecovirimat is an antiviral medication taken by mouth in capsule form, and it is the first and only treatment specifically approved for mPOX (monkeypox virus) infection. This medication works by blocking an essential viral protein called VP37, which is needed for the release of viral particles from infected cells, thereby stopping the spread of the virus in the body. Tecovirimat belongs to the class of antiviral medicines and is indicated mainly for the treatment of severe mPOX infections, especially in patients at increased risk of complications. The medication is currently being evaluated in clinical trials to confirm its effectiveness in treating skin and mucosal lesions caused by the monkeypox virus.

  • Brincidofovir

    Brincidofovir is an antiviral medication taken by mouth in tablet form, and it is an improved version of cidofovir with better bioavailability and reduced toxicity. This medication works by interfering with the replication of viral DNA, blocking the viral DNA polymerase enzyme that the virus needs to multiply in host cells. Brincidofovir belongs to the class of nucleotide antivirals and is used as an alternative treatment for mPOX infections, especially in patients who cannot tolerate other antiviral therapies. The medication is being evaluated in clinical trials to demonstrate its effectiveness in speeding up the healing of lesions caused by the monkeypox virus and in shortening the duration of the illness.

Investigated diseases

Monkeypox – Monkeypox is a viral disease caused by the monkeypox virus, which is similar to the virus that causes smallpox. It begins with symptoms such as fever, headache, muscle aches, and fatigue. Swollen lymph nodes are a distinctive feature that differentiates it from smallpox. The disease progresses to a rash that starts on the face and spreads to other parts of the body, forming lesions that go through stages of macules, papules, vesicles, pustules, and scabs. The lesions eventually heal, often leaving scars. The disease is typically self-limiting, with symptoms lasting from 2 to 4 weeks.
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501979-10-00Estimated enrolment335 patientsSponsorUniversitair Medisch Centrum Utrecht

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