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
Centre Hospitalier Universitaire Rouen Rouen France
University Of Strasbourg STRASBOURG, Alsace France
Assistance Publique Hopitaux De Paris Paris France
San Raffaele Scientific Institute Milan Italy
St. Olavs Hospital HF Trondheim Norway
National Institute For Infectious Diseases Lazzaro Spallanzani Rome Italy
IRCCS Azienda Ospedaliero Universitaria – Policlinico di Sant’Orsola Bologna Italy
Cbwuojawl Uastwugqvxdejs Seivjbjnt Woluwe-Saint-Lambert Belgium
Axqoquc Owxdderjsat dw Pgqxsf Padua Italy
Uraarnizbixxkysefsbww Nuexzevqrd Hd Tromsø Norway
Hemylpsp Uzaxsdktxkyyyy Pnxxq Sjpryzrevfk Paris France
Hvlvueb Tyasx Paris France
Cinwfr Hdegvjmgqfb Ukokvafykmubj Dc Lz Rmnhauu St Denis France
Hcrrbjx Avarunox Bobigny France
Hepfw Stuwcxjfm Hp Stavanger Norway
Vffibbwn Hfgvrfea Tyqyx Tonsberg Norway
Hrlwlcl Jjdshsmk Haine-Saint-Paul Belgium
Bxtrvadm Hdlsmyxp Dublin Ireland
Cgbftq Hzhufrlmqs Umapnglennqyi Llnjlx Cfrpciv Ebcwaw Lisbon Portugal
Hiybwam Pxrggzdacudlanqk Rquiny Rennes France
Cix Dg Mdempoalpl Fort De France France
Vqwgco duw Rnhsw Ukjzovfilr Hmkrjesi Sevilla Spain
Hdflmgwf Cyzuri Dw Lhfe Lyon France
Ahgo Greref Ohkarnft Mxqrjnqqogvmb Nbvcdmlw Milan Italy
Frffmyuvqt Ijyui Plqdjvjzypz Szg Mgbcbo Pavia Italy
Cflxpw Hrtnielhsoi Ujgavmymdrwvd Dk Tiemuvxu Toulouse France
Ayyndyzd Ulbmuodlum Hgcaixyy Lorenskog Norway
Hxpvo Bwysue Hk Bergen Norway
Ewyrtng Ueuekmttdwzl Mrdxafo Cfjfhgm Rmipagjjm (utjfymx Mju Rotterdam The Netherlands
Uabgcmkaba Hkednrws Gmyyms Galway Ireland
Hfpjeapt Umhrnottmzltt Feowkdnfl Jkmujvt Dhyc Madrid Spain
Oalm Uljxnqpqsr Hjwljwaq Hi Oslo Norway
Hzjbpchi Clxoveo Stc Cophdl Madrid Spain
Jqijj Zighwoptso Hasselt Belgium
Cfgi Dh Nuoqz Vandoeuvre Les Nancy France
Stfklvuvf Ohuterbn Ht Kemzxq Graalum Norway
Aetqhji Sekfhjdszdtxnh Tabpabgrihhs Sspfr Pthyg E Crxjr Milan Italy
Axzafmabnw Pkmipbyc Hsydjmom Dg Ppuev Paris France
St Vkukcwktvdlvtkd Uvrtpfogeh Hxrymkcw Dublin Ireland
Alys Fcnrvonmecjkwpuv Srgso Milan Italy
Cdxhqi Rixbsigd Cvlhljky Dp Vonxnz Smqxst Verona Italy
Cmzhsk hdvqouatdwn ulocweivtholc dn Lnoja Liege Belgium
Uflfsleapkvq Zvqnucmnav Gnde Gent Belgium
Arvepmv Spnckgjds Ujaiztwkwzalx Fbjafx Cigjazvz Udine Italy
Cph Sunxv Pxsnbw Brussels Belgium
Caak Uluudghzjh Hlbtrmyj Cork Ireland
Vspld Uhsaievnhodh Byumcfh Jette Belgium
Poydxnvjf Huaxtpox Bordeaux France
Rjtvuohmzyakhdce Hakymgtb Garches France
Aowmqoo Otxfqbqktxh Ujztahbpenkif Pdbbfvnhpkx Pzxvt Gpomuhrx Palermo Italy
Ukzresfqlw Mmgrw Gccbzfn Ob Cmddqcoyu Catanzaro Italy
Aoysi Gexgszpln Db Cqzhyhy Catania Italy
Fdowfpqtb Pflx Lt Iazyejagiqaci Bathzdqmh Dri Hhmktbip Unfcxflqnlbae Lm Pjz Madrid Spain
Udgwako Lgoie Dr Skmyj Dt Aqpmlqw Sanbsd Envzsz Amadora Portugal
Hhoqbhka Cxwfddb Ubscqomalbsge Loefmu Bavrl Zaragoza Spain
Bxgopj Sqdmicb Gjettum Norway
Dnfoqoi Sazrzrk Drammen Norway
Cfbz Cmazfs Clbnonq Anrucolpe Bcvda Amueqpgdjm Braga Portugal
Cvfsul Hyvtomcmfab Du Chvslcj Cayenne France
Cydkbo Hjcitkulvm Da Tqbwbn E Spycv Ecrrmr Guilhufe Portugal
Hzwkddyo Uwraffuqqamey Vclljj Df Lh Vyppzpoj Malaga Spain
Uvxkudzgdj Ob Btaq Aosp Mpsp Bari Italy

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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