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

3 1 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliera di Padova Padua Italy
Centre Hospitalier Universitaire De La Reunion St Denis France
Hospices Civils De Lyon Lyon France
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
University Hospital Galway Galway Ireland
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
San Raffaele Scientific Institute Milan Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo Milan Italy
Assistance Publique Hopitaux De Paris Paris France
Sykehuset Oestfold HF Kalnes Graalum Norway
St. Olavs Hospital HF Trondheim Norway
Universitetssykehuset Nord-Norge HF Tromsø Norway
Centre Hospitalier Universitaire Rouen Rouen France
Hopitaux Universitaires Pitie Salpetriere Paris France
Hopital Tenon Paris France
Hôpital Avicenne Bobigny France
Vestfold Hospital Trust Tonsberg Norway
University Of Strasbourg STRASBOURG, Alsace France
Virgen del Rocío University Hospital Sevilla Spain
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Toulouse Toulouse France
Oslo University Hospital HF Oslo Norway
Jessa Ziekenhuis Hasselt Belgium
National Institute For Infectious Diseases Lazzaro Spallanzani Rome Italy
ASST Fatebenefratelli Sacco Milan Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Centre hospitalier universitaire de Liege Liege Belgium
Universitair Ziekenhuis Gent Gent Belgium
Azienda Sanitaria Universitaria Friuli Centrale Udine Italy
CHU Saint Pierre Brussels Belgium
Vrije Universiteit Brussel Jette Belgium
Pellegrin Hospital Bordeaux France
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
ARNAS Garibaldi Di Catania Catania Italy
Unidade Local De Saude De Amadora Sintra E.P.E. Amadora Portugal
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Baerum Sykehus Gjettum Norway
Drammen Sykehus Drammen Norway
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Centre Hospitalier De Cayenne Cayenne France
Beaumont Hospital Dublin Ireland
Hôpital Pontchaillou-CHU Rennes Rennes France
CHU De Martinique Fort De France France
Hospital Universitario Virgen De La Victoria Malaga Spain
IRCCS Azienda Ospedaliero Universitaria – Policlinico di Sant’Orsola Bologna Italy
Centro Hospitalar Universitário Lisboa Central E.P.E. Lisbon Portugal
Aaiuhlqy Uaiwxkngpr Hsyyghjw Lorenskog Norway
Hqgjf Blktdq Hb Bergen Norway
Czswprujl Uopmjxkbkfcttn Sefqkqvmq Woluwe-Saint-Lambert Belgium
Hqmjp Smyvjujtx Hr Stavanger Norway
Hahpfew Jktzufid Haine-Saint-Paul Belgium
Ercdgsk Ubigfyusjyqd Merqvdn Cbyghxa Rgntsfied (hryhjex Msj Rotterdam The Netherlands
Cdbz Dt Nebcn Vandoeuvre Les Nancy France
Sq Vpmghwdzpmielgu Ukdrxbabui Haupysdr Dublin Ireland
Cenr Uyyygpnodo Hgtwjbjv Cork Ireland
Renkwgwamlskenbl Hxrdszgy Garches France
Unohbeeitl Mwjut Grkkbrz Op Ckydgpdud Catanzaro Italy
Fezdbacnl Pqfi Ll Ibaumhtqdlmyr Bbhvbbntt Dwq Hlnfkywo Uasppszacrkde Lc Pfa Madrid Spain
Cvamdc Hgelwmzoov Dz Trjwva E Suodj Eudemu Guilhufe Portugal

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
27.06.2022
France France
Not recruiting
27.06.2022
Ireland Ireland
Not recruiting
27.06.2022
Italy Italy
Not recruiting
27.06.2022
Norway Norway
Not recruiting
27.06.2022
Portugal Portugal
Not recruiting
27.06.2022
Spain Spain
Not recruiting
27.06.2022
The Netherlands The Netherlands
Not recruiting
27.06.2022

Trial locations

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.

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 ID:
2022-501132-42-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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