Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Canadian trial tests monkeypox drug in outpatients

NCT ID NCT05534165

Disease control Sponsor: Marina Klein Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Canadian study tests whether the antiviral drug tecovirimat (TPOXX) helps non-hospitalized adults with monkeypox recover faster. About 120 participants will receive either the drug or a placebo. The main goal is to see how quickly skin lesions heal and whether running such a trial in Canada is practical.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tecovirimat (also known as TPOXX), an antiviral drug
What this could lead to
If it works, this could provide an effective treatment for monkeypox that speeds up recovery and reduces symptoms in outpatients.
What could go wrong
This is a feasibility study with only 120 participants, so results may not be definitive. The trial is currently suspended, and tecovirimat may not work better than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Any sex, ≥ 18 years of age inclusive at the time of signing informed consent. 2. Weight ≥ 40 kg 3. Laboratory-confirmed or presumptive monkeypox infection: Laboratory-confirmed monkeypox infection is defined as determined by PCR, culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 4 days of randomization OR Presumptive diagnosis: * Skin lesion(s), mucosal lesion(s) or proctitis consistent with a high probability of monkeypox infection in the opinion of the site investigator AND * Sexual contact with 1 or more persons in the 21 days prior to symptom onset or any person with known close exposure to another person known to be infected with monkeypox infection. Presence of active skin or mucosal lesion(s). 4. Appropriate to be managed without hospitalization. 5. The participant (or legally acceptable representative) has provided documented informed consent and comply to the require procedures for the study. Exclusion Criteria: 1. Weight \< 40 kg 2. Current or past use of tecovirimat 3. Inability to provide informed consent 4. The patient's own doctor considers there to be either a definite indication or a definite contraindication to the patient receiving tecovirimat 5. Participated in an interventional clinical study \< 28 days prior to the day of first IP administration (Day 0) or plans to do so while enrolled in this study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Monkeypox are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

monkeypox

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Monkeypox

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • St. Paul's Hospital, BC Centre for Excellence in HIV/AIDS

    Vancouver, British Columbia, V6Z 1Y6, Canada

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.