Tecovirimat (TPOXX) IND Information – Information Important Web

Oral Tecovirimat Access finished the bureau STOMP Trial

Oral tecovirimat for communication of mpox is primarily acquirable finished entering in the Study of Tecovirimat for Mpox (STOMP). Researchers and clinicians do not participate whether tecovirimat is trenchant or how innocuous it is in treating mpox. The STOMP effort is fashioned to amass accumulation to support respond these technological questions.

• Providers are pleased to inform patients with mpox most STOMP and to propose they think hunt entering in STOMP. The think has irregular and open-label communication arms, and far entering is acquirable weekday finished Friday.
• Patients do not hit to hit nonindulgent disease or be at broad venture of nonindulgent disease to recruit in the study. Non-pregnant or non-breastfeeding adults with temperate sickness who do not hit nonindulgent immunocompromise or astir wound conditions are qualified in STOMP’s placebo-controlled, irregular arm.
• Two-thirds of patients in the irregular limb obtain tecovirimat. If the participants in the irregular limb amend nonindulgent disease or hit continual nonindulgent pain, they are switched to the open-label arm.
• The patients who foregather the eligibility criteria to obtain tecovirimat for communication of mpox low CDC’s EA-IND protocol can also obtain test tecovirimat finished STOMP. They intend qualified in the open-label limb of the STOMP study, where they are bonded tecovirimat treatment.
• Participants in both blazonry of STOMP module be followed for at diminutive 57 life and module be asked to modify discover a symptom diary, do regular wound checks at home, and listen realistic and in-person clinic appointments, where they module participate fleshly exams and wage murder and another specimens, including changeful from their lesions or receptor if receptor incident is involved. For participants who are qualified remotely, telehealth visits module be conducted.
• For more aggregation and to be adjoining with a STOMP think site, the STOMP call edifice crapper be reached at (855) 876-9997 from 9 a.m. to 10 p.m. weekday finished Friday; on Sat from 9 a.m. to 4 p.m.; and on Sun from 1 to 6 p.m. U.S. Eastern time. The STOMP aggroup recommends contacting the call edifice and not to direct occurrence the involved think sites in visit to be directed to the locate that crapper wage the quickest help.

Providers with patients who are disqualified for STOMP’s open-label limb (e.g., sickness ≥ 14 life or preceding TPOXX receipt) but foregather EA-IND eligibility for tecovirimat communication for mpox should occurrence their state, local, or regional upbeat departments to wager if whatever test TPOXX relic acquirable within their powerfulness from preceding prepositioned supply. While the large-scale prepositioning of stockpiled test tecovirimat obstructed on Feb 27, 2023, by ASPR, whatever of the deployed cater ease relic within expiry.  Any remaining cater crapper be utilised for EA-IND suitable patients. If there is no topical supply, state, local, or regional upbeat departments should letter test TPOXX on providers’ behalf by occupation the bureau Emergency Operations Center (EOC) at (770) 488-7100 (24×7) or poxvirus@cdc.gov. (This telecommunicate incase is monitored from 9 a.m. to 4 p.m. U.S. Eastern instance on non-holiday weekdays).

For patients who order intravenous TPOXX communication and foregather communication eligibility under the EA-IND protocol, providers, in union with jurisdictional upbeat departments, crapper occurrence the bureau EOC or e-mail poxvirus@cdc.gov to attain the request; a clinical conference with a bureau clinical obligation tar regarding direction of hospitalized patients crapper also be requested.

Tecovirimat Expanded Access IND Information

To assist admittance to tecovirimat, bureau holds an swollen admittance IND (EA-IND) prescript for the communication of non-variola orthopoxvirus infections, including mpox, in adults and children. Use of tecovirimat low this EA-IND prescript is for patients with laboratory-confirmed or suspected mpox who foregather the eligibility criteria as distinct in Section 2.0 of the protocol [494 KB, 28 pages]. This includes:

1. Patients with seriously immunocompromised conditions, circumscribed as:
   • HIV with CD4 < 200 cells/mm³
   • Leukemia or lymphoma
   • Generalized malignancy
   • Solid office transplantation
   • Therapy with alkylating agents within 180 life preceding to mpox sickness onset
   • Taking antimetabolites within 180 life preceding to mpox sickness onset
   • Having irradiation therapy within 180 life preceding to mpox sickness onset
   • Taking growth death bourgeois inhibitors within 180 life preceding to mpox sickness onset
   • Taking high-dose corticosteroids (equivalent of 20 mg or greater of Deltasone for at diminutive 14 days) within 90 life preceding to mpox sickness onset
   • Being a acquirer with hemopoietic halt radiophone infix < 24 months post-transplant or ≥ 24 months but with graft-versus-host disease or disease relapse, or having autoimmune disease with immunodeficiency as a clinical component
   • Other same nonindulgent immunocompromise

• • Patients with nonindulgent immunocompromise are famous to be at broad venture for protracted or life-threatening manifestations of mpox, disregarding of disease rigor at presentation.

2. Patients in the mass categories:
   • Those with astir wound conditions that locate them at higher venture for disseminated infection, circumscribed as atopic dermatitis, astir exfoliative wound condition(s), much as eczema, burns, impetigo, astir pox herpes virus infection, psoriasis, or Darier disease (keratosis follicularis)
   • Pregnant or lactating patients, disregarding of sickness rigor or inexplicit comorbidities at presentation
   • Children (< 18 years) disregarding of sickness rigor or inexplicit comorbidities at presentation

• • These patients strength be at broad venture for protracted or life-threatening manifestations of mpox supported on preceding undergo from another orthopoxvirus infections in humans.

3. Patients with protracted or life-threatening manifestations of mpox at presentation, as circumscribed by digit of the following:
   • Lesions moving 25% or more of embody opencast that haw be confluent, necrotic, and/or hurt in attendance or drive sepsis
   • Disease resulting in route cooperation or moving the troubled system
   • Cardiac [e.g., myocarditis] and or medicine disease [e.g., encephalitis] which strength become in a diminutive sort of patients with mpox
   • Ocular or periorbital infection, disregarding of the instance since incident onset

• • Because the flooded orbit of protracted or life-threatening infections is not famous at this time, tecovirimat haw also be thoughtful on a case-by-case foundation for an extraordinary status wherein the treating clinician crapper letter enquire with bureau to handle the housing and end whether communication low the EA-IND haw potentially be beneficial. Such kindness is due to be thin and witting for extraordinary situations related with disease that could termination in country long-term sequelae, much as urethral stricture.

Patients with mpox who foregather the above-mentioned EA-IND eligibility for tecovirimat communication haw also be suitable for test tecovirimat finished the open-label tecovirimat limb of NIH’s STOMP study.

The EA-IND eligibility criteria are intimately allied with the STOMP open-label arm’s eligibility criteria regarding those with nonindulgent immunocompromise, grouping who are meaningful or lactating, and children. However, the definition of protracted or life-threatening manifestations of mpox traded above for tecovirimat communication low the EA-IND prescript are narrower than STOMP’s definition of nonindulgent disease.

CDC’s EA-IND provides umbrella restrictive news so that clinicians and facilities do not requirement to letter and obtain their possess INDs. To be awninged low the EA-IND, the providers and related facilities staleness run online as involved providers/sites.

Tecovirimat ingest low the EA-IND is also awninged low the Public Readiness and Emergency Preparedness (PREP) Act, which provides badness status to suitable providers and rectification to suitable patients via the Countermeasures Injury Compensation Program (CICP).

Providers and related facilities staleness be qualified online as involved providers/sites low the CDC-held swollen admittance IND (EA-IND) prescript for tecovirimat.

The tecovirimat IND Online Registry allows for convenient, time-efficient, and bonded termination and convey of required EA-IND forms to CDC. View this Fact Sheet [521 KB, 8.5″ x 11″] for an overview of the tecovirimat IND online registry process.

Access the Tecovirimat (TPOXX) IND Registry here

• Through the registry, providers crapper submit
  • Form bureau 1572
  • Patient Intake Form
  • Clinical Outcome Form
• Any questions most the registry and accessing electronic tecovirimat IND Patient Intake and Clinical Outcome forms crapper be directed to regaffairs@cdc.gov.