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

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STOMP Clinical Study Information
Summary of Recent Changes
Tecovirimat (TPOXX) IND Online Registry

Tecovirimat IND Protocol
Institutional Review Board (IRB) Approval
How to Obtain Tecovirimat

STOMP Clinical Study Information

Providers should inform patients about the Study of Tecovirimat for Human Mpox 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

Tecovirimat expanded access Investigational New Drug (EA-IND) Protocol (version 6.2 dated October 24, 2022) [527 KB, 24 pages] was amended to:
- Add tecovirimat treatment availability through a randomized controlled clinical trial under Section 2.1 Tecovirimat Eligibility of the protocol.
- Clarify the labeled contraindication of intravenous (IV) tecovirimat use in patients with severe renal impairment and certain exceptions allowed based on individual risk-benefit assessment and clinical determination by the treating providers in consultation with CDC.
- Update the oral tecovirimat dose for infants weighing less than 3 kg and dose preparation instructions for children who weigh less than 3 kg or weigh between 3 kg to less than 6 kg per Food and Drug Administration (FDA) recommendations. Corresponding Attachment 3 (Instructions for Opening and Mixing Tecovirimat Capsules with Water or Food) [496 KB, 2 pages] was also updated accordingly.
- Clarify that treatment duration beyond the standard 14-day course may be considered at short increments of extension at a time (e.g., 7 to 10-day or 14-day course) with monitoring for clinical improvement, virologic response, or lack of response to reassess continuation or discontinuation for treatment.
- Add information on the implementation of an online registry required for new providers and the transition to electronic Patient Intake and Clinical Outcome forms.
- Add selected adverse events of interest for monitoring and reporting to CDC.

View Previous Updates

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 [598 KB, 8.5″ x 11″] 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 regaffairs@cdc.gov.

Tecovirimat IND Protocol

Because tecovirimat is FDA-approved only for treatment of smallpox, CDC holds a protocol (version 6.2 dated October 24, 2022) [527 KB, 24 pages] to allow access to and use of tecovirimat for treatment of non-variola orthopoxvirus infections, including mpox, in adults and children. The tecovirimat EA-IND protocol is intended to be used in concert with CDC’s guidance for treatment.
- - The protocol includes Instructions for mixing tecovirimat capsules with food or water [496 KB, 2 pages]: This patient instruction sheet explains how to open tecovirimat capsules and mix with food or water for infants and children who cannot swallow pills.

The EA-IND provides umbrella regulatory coverage so that clinicians and facilities do not need to request and obtain their own INDs. Administration under the EA-IND is also covered under the PREP Act, which provides liability immunity to qualified providers and compensation to eligible patients via the Countermeasures Injury Compensation Program (CICP).
On October 26, 2022, the CDC IRB approved [123 KB, 1 page] a protocol amendment; continuation was approved on July 20 [111 KB, 1 page].
Clinicians, care facilities, and hospitals providing tecovirimat should immediately transition to the revised protocol (version 6.2 dated October 24, 2022) [527 KB, 24 pages]. Healthcare providers will be responsible for completing the following forms:

Required

Informed Consent Form: English [238 KB, 6 pages] Obtain prior to treatment.
1. Other languages: Spanish [263 KB, 7 pages]
2. Alternative Consent Forms that can be used to obtain informed consent:
  - Short Form (English) [155 KB, 3 pages] | Spanish [140 KB, 4 pages]
  - Written Summary (English) [229 KB, 5 pages] | Spanish [284 KB, 6 pages]
Patient Intake Form: Baseline assessment. Access the electronic form through the Tecovirimat IND Online Registry.
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.
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 may have pre-positioned supplies of oral tecovirimat. Clinicians and care facility pharmacists needing to obtain oral tecovirimat supply should first contact their state/territorial health department.
For clinicians with patients requiring intravenous tecovirimat treatment, requests can be made by contacting the CDC Emergency Operations Center (770-488-7100).
For urgent clinical situations, providers can contact the CDC Emergency Operations Center (770-488-7100) for clinical consultation on patient cases.

Previous Updates

Tecovirimat (TPOXX) expanded access Investigational New Drug (EA-IND) Protocol (version 6.1 dated August 10, 2022) was amended to:
- Shorten the Patient Intake form with required vs. optional data fields delineated.
- Make the Clinical Outcome form optional for one time follow-up within 3-14 days after treatment completion. Eliminate during treatment follow-up.
- Extend the time for returning the requested forms (e.g., within 7 calendar days of treatment initiation).
- Add drug interactions information on tecovirimat and certain antiretroviral drugs.
- Further clarify IV tecovirimat infusion via syringe pumps. Avoid use of pre-filled IV bags and glass IV bottles.
- Update opening the capsule and mixing with food instructions (replaced water with liquids).
- Include an alternative option for obtaining informed consent (short form with a written summary).