CDC is updating webpages with the term "mpox" to reduce stigma and other issues associated with prior terminology. This change is aligned with the recent World Health Organization decision.

Information for Healthcare Providers: Tecovirimat (TPOXX) for Treatment of Monkeypox

STOMP Clinical Study Information

Providers should inform patients about the Study of Tecovirimat for Human Monkeypox Virus (STOMP) for their voluntary participation. If enrollment in STOMP is not feasible for a patient (e.g., a clinical trial site is not geographically accessible), tecovirimat use under CDC’s expanded access protocol should be in concert with CDC’s guidance for treatment. Demographics of patients receiving tecovirimat under the EA-IND are available on CDC’s website.

Summary of Recent Changes

TPOXX IND Registry for Providers and Facilities Thumbnail for PDF

Tecovirimat (TPOXX) IND Online Registry

NEW: Tecovirimat (TPOXX) IND Online Registry for Providers and Facilities and Transition to Electronic Patient Intake and Clinical Outcome Forms

  • New providers and affiliated facilities can now register online as participating providers/sites under the CDC-held EA-IND for tecovirimat.
Access the Tecovirimat (TPOXX) IND Registry here
  • New providers and affiliated medical facilities providing tecovirimat under the EA-IND protocol must register with the tecovirimat IND online registry starting October 28, 2022.
  • Through the registry, providers can submit
    • Form FDA 1572
    • Patient Intake Form
    • Clinical Outcome Form
  • The tecovirimat IND Online Registry allows for convenient, time-efficient, and secure completion and return of EA-IND forms to CDC. View this Fact Sheet for an overview of the tecovirimat IND online registry process.
  • Providers who have returned required IND forms prior to the online registry transition are grandfathered in as participating providers under the EA-IND. Any providers with valid email addresses on record should have received emails providing them access to the electronic Patient Intake and Clinical Outcome forms on October 25, 2022.
  • Any questions about the registry and transition to electronic tecovirimat IND Patient Intake and Clinical Outcome forms can be directed to CDC IMS TPOXXIND (eocevent477@cdc.gov).

Tecovirimat IND Protocol

Required

  1. Informed Consent Form: English [238 KB, 6 pages] Obtain prior to treatment.
    1. Other languages: Spanish [263 KB, 7 pages] | Arabic [308 KB, 6 pages] | Korean [431 KB, 7 pages] | Russian [245 KB, 7 pages] | Simplified Chinese [316 KB, 6 pages] | Tagalog [243 KB, 7 pages] | Vietnamese [338 KB, 7 pages]
    2. Alternative Consent Forms that can be used to obtain informed consent
  2. Patient Intake Form: Baseline assessment. Access the electronic form through the Tecovirimat IND Online Registry.
  3. FDA Form 1572: One signed 1572 and treating clinician’s CV per facility suffices for all tecovirimat treatments administered under the EA-IND at the same facility. Access the electronic form through the Tecovirimat IND Online Registry.
  4. Serious Adverse Events: Per FDA requirement, report life-threatening or serious adverse events associated with tecovirimat by completing a PDF MedWatch Form [956 KB, 5 pages] and returning it to CDC via email (regaffairs@cdc.gov) within 72 hours of awareness or sooner, if possible. The PDF MedWatch Form can also be downloaded from the FDA website. Note: The MedWatch Form can only be viewed on the Adobe desktop app. Please save or download the form for viewing.

Optional

  • Clinical Outcome Form: Progress and outcome information post treatment. Access the electronic form through the Tecovirimat IND Online Registry.
  • Lesion samples for resistance testing: Lesion samples may be sent to CDC for tecovirimat-treated patient with persistent lesions and/or any new lesions that develop during and/or after tecovirimat treatment to assess for development of antiviral resistance mutations. See Optional Lesion Samples to CDC for Resistance Testing [147 KB, 2 pages] for instructions on collection, storage, and submission of samples.
  • Pharmacokinetic samples for testing: During tecovirimat treatment, plasma samples may be collected to monitor tecovirimat levels for adequate drug exposure in patients. Optional Pharmacokinetic Samples for Testing [375 KB, 4 pages] has instructions on collection, storage, and submission of samples.

Institutional Review Board (IRB) Approval of Tecovirimat IND Protocol

  • CDC IRB serves as the central IRB for review and approval. Facilities may elect to rely on the CDC IRB for centralized review and approval by submitting a request to the CDC’s Human Research Protection Office within 7 calendar days of tecovirimat treatment at your facility. CDC will promptly document an agreement in writing using the CDC IRB Authorization Agreement (Sample Template) [4 MB, 2 pages], which must be signed by both parties.
  • Facilities that elect to obtain their own IRB review must ensure compliance with applicable FDA regulations related to the tecovirimat EA-IND protocol. Note the posted tecovirimat EA-IND protocol and attachments must be used without any changes being made by the IRB.
  • Because this tecovirimat EA-IND protocol is solely for treatment use, CDC determined that its use does not constitute research involving human subjects as defined by 45 CFR 46.102, therefore, the federal-wide assurance requirements do not apply.

How to obtain Tecovirimat

  • Tecovirimat is available through the Strategic National Stockpile and jurisdictions have pre-positioned supplies of oral tecovirimat. Clinicians and care facility pharmacists needing to obtain oral tecovirimat supply should contact their state/territorial health department.
  • For clinicians with patients requiring intravenous tecovirimat treatment, requests can be submitted to eocevent482@cdc.gov with the health department copied on the request.
  • For urgent clinical situations, providers can contact the CDC Emergency Operations Center (770-488-7100) for clinical consultation on patient cases.

Previous Updates