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Study on Monkeypox Virus Disease: Effects of Tecovirimat in Patients with and without Antiviral Treatment

Verified siteRegistered drugNo placebo
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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 virus disease, which is sometimes referred to as mpox. The study involves a treatment using a medication called Tecovirimat, which is taken in the form of 200 mg hard capsules. The purpose of the study is to observe the clinical outcomes in patients with mpox who are treated with tecovirimat or other antiviral drugs, as well as those who are not treated with these medications.

Participants in the study will be monitored over a period of time to see how their condition progresses. The study will look at how quickly the skin lesions caused by the mpox virus heal, starting from the date of a positive test or the beginning of treatment, and continuing for up to 14 days. The study will also assess the overall health status of participants on days 14 and 28, and check for any signs of the disease returning on days 60 and 180. Additionally, the study will monitor the levels of mpox virus DNA in the throat, blood, and lesion swabs at various points during the study.

For those receiving tecovirimat or other antiviral treatments, the study will track any serious side effects or unexpected reactions within 28 days of starting the study. The study will also consider the outcomes for pregnant women who are participating. This research aims to provide valuable information on the effectiveness and safety of tecovirimat and other antiviral treatments for mpox.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that informed consent is provided. This means understanding the study's purpose and agreeing to participate.

    Eligibility requires either a confirmed diagnosis of monkeypox virus disease or being managed as a presumptive case while awaiting laboratory confirmation.

  2. Step 2

    Treatment initiation

    If receiving treatment, the medication used is tecovirimat, administered as 200 mg hard capsules taken orally.

    The dosage and frequency of administration will be determined by the healthcare provider based on individual needs.

  3. Step 3

    Monitoring and assessments

    Regular assessments will be conducted to monitor clinical status and virological status. These assessments occur on days 4, 8, 14, and 28.

    Clinical status is evaluated using an ordinal scale, which considers the resolution of lesions and any serious complications.

  4. Step 4

    Lesion resolution

    The primary goal is to observe the time it takes for lesions to resolve. This is defined as the first day when all lesions are healed, and there are no serious complications.

    This observation period lasts up to 14 days from the start of treatment or inclusion in the study.

  5. Step 5

    Follow-up evaluations

    Follow-up evaluations are conducted on day 60 and day 180 to check for any recurrence or relapse of the disease.

    These evaluations help in understanding the long-term outcomes of the treatment.

  6. Step 6

    Adverse events monitoring

    For those receiving tecovirimat or other antiviral treatments, monitoring for any serious adverse events or unexpected reactions is conducted within 28 days of enrollment.

    This ensures the safety and well-being of participants throughout the study.

Who can join the trial?

5 criteria

  • Patients must have a **laboratory-confirmed** case of **monkeypox virus disease** or be managed as a **presumptive case** while waiting for lab results. A presumptive case means the doctor thinks you have the disease based on your symptoms, even if lab results are not yet available.
  • Patients must provide **informed consent** to participate in the study. This means you agree to join the study after being told about its details, risks, and benefits.
  • Both **male** and **female** patients can participate.
  • Patients of all ages are eligible, including children, adults, and the elderly.
  • Patients from **vulnerable populations** can participate. This includes groups who might need special care or protection, like those with certain health conditions or social situations.

Who cannot join the trial?

8 criteria

  • Patients who are not diagnosed with Monkeypox virus disease cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range includes children, teenagers, and adults.
  • Patients who are not willing to follow the study procedures cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a known allergy to the study medication or similar drugs cannot participate.
  • Patients who have received certain treatments for Monkeypox virus disease before the study starts cannot participate.
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Investigated drugs

Tecovirimat is a medication used to treat infections caused by the mpox virus. It works by stopping the virus from spreading in the body, helping to reduce the severity of the disease and speed up recovery. Patients in the trial may receive tecovirimat to see how it affects their symptoms and overall health outcomes.

What is already known about the treatment

Tecovirimat – Tecovirimat is administered orally in the form of capsules and is currently being studied for its effectiveness in treating monkeypox virus disease. It is an antiviral medication that works by inhibiting a protein in the virus, preventing it from spreading within the body. Tecovirimat is classified as an antiviral drug and is primarily indicated for the treatment of infections caused by orthopoxviruses, such as monkeypox.

Investigated diseases

Monkeypox virus disease – Monkeypox virus disease is a viral infection caused by the monkeypox virus, which is part of the same family of viruses as smallpox. The disease typically begins with fever, headache, muscle aches, and fatigue. As the disease progresses, a rash develops, often starting on the face and then spreading to other parts of the body. The rash goes through several stages, including macules, papules, vesicles, pustules, and finally crusts, which eventually fall off. The disease is usually self-limiting, with symptoms lasting from two to four weeks. In some cases, complications can occur, but these are not common.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501132-42-00Estimated enrolment1 400 patientsSponsorUniversity Of Oxford

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