This study is currently recruiting participants.
Number
001124-I
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Enrolling by Invitation Gender: Male & Female Min Age: N/A Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
None
Keywords
Monkeypox; Infection; Mpx
Recruitment Keyword(s)
Condition(s)
Monkeypox
Investigational Drug(s)
Tecovirimat (TPOXX(R))
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
The purpose of this expanded access IND (compassionate use) program is to provide stockpiled tecovirimat for treatment of non-variola orthopoxvirus infections (e.g., monkeypox, vaccinia, or other human virus infection identified as an orthopoxvirus) and secondary treatment of complications from replication-competent vaccinia vaccine in adults and children.
It is also to monitor clinical use of tecovirimat, including any occurrence of serious adverse events, and patient monitoring and outcomes information are also intended to be collected under this expanded access IND program to the extent feasible (e.g., baseline clinical conditions, progression/improvement post treatment, recovered or not recovered from orthopoxvirus infection).
All patient populations, who meet eligibility criteria, can receive tecovirimat treatment under this protocol. This includes children and all adults including pregnant and nursing individuals, and prisoners. Clinical considerations of tecovirimat therapy during an outbreak may evolve depending on the duration and nature of the outbreak and event-based information that may become available during the outbreak.
Tecovirimat treatment may be initiated for 1) patients with laboratory confirmed non-variola orthopoxvirus infection or suspected infection based on known exposure(s) and/or clinical manifestations of disease 2) patients with complications of replication-competent vaccinia infection (e.g., serious inadvertent inoculation with vaccinia, eczema vaccinatum, severe generalized vaccinia, or progressive vaccinia) resulting from vaccination, secondary transmission, or other exposure are eligible for treatment with tecovirimat 3) post-exposure prophylaxis on an individual case-by-case basis in consultation with CDC.
Ineligibility includes 1) patient or legally authorized representative unwilling to sign an informed consent and refuse tecovirimat treatment 2) known allergy to tecovirimat and/or inactive ingredients in tecovirimat 3) for IV tecovirimat only: patients with severe renal impairment (creatinine clearance <30 mL/min).
Adults and children who are unable to take oral therapy or for whom there is a concern that oral drug absorption may be altered should be considered for treatment with IV tecovirimat.
In certain clinical situations, modifications to the dose, frequency, and duration may be necessary depending on the individual patient s clinical condition, disease progression, therapeutic response, and/or clinical judgement in consultation with CDC and FDA as appropriate.
Form FDA 1572 and the CDC patient intake form will be submitted to the CDC within 7 days of initiating treatment with tecovirimat. Any serious or life-threatening AEs and/or medication errors associated with tecovirimat will be reported to the CDC within 72 hours of awareness of the event.
The CDC clinical outcome form and diary form are optional and will be completed if feasible.
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INCLUSION CRITERIA: -Patients with severely immunocompromised condition(s) defined as: --HIV with CD4 < 200 cells/mm^3 --Leukemia or lymphoma --Generalized malignancy --Solid organ transplantation --Therapy with alkylating agents within 180 days prior to mpox illness onset --Antimetabolites within 180 days prior to mpox illness onset --Radiation therapy within 180 days prior to mpox illness onset --Tumor necrosis factor inhibitors within 180 days prior to mpox illness onset --High-dose corticosteroids (equivalent of 20 mg or greater of prednisone for at least 14 days) within 90 days prior to mpox illness onset --Being a recipient with hematopoietic stem cell transplant < 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 comparable severe immunocompromising condition Persons with severe immunocompromise are known to be at high risk for protracted or life-threatening manifestations of mpox regardless of disease severity at presentation. -Patients in the following categories: a) Persons with active skin conditions placing the person at higher risk for disseminated infectiondefined as: atopic dermatitis; active exfoliative skin condition(s) such as eczema, burns, impetigo, active varicella zoster virus infection, psoriasis, or Darier disease (keratosisfollicularis) b) Pregnant or lactating individuals, regardless of illness severity or underlying comorbidities at presentation c) Children (< 18 years), regardless of illness severity or underlying comorbidities at presentation These patients might be at high risk for protracted or life-threatening manifestations of mpox based on prior experience from other orthopoxvirus infections in humans. -Patients with protracted or life-threatening manifestations of mpox at presentation as defined byone of the following: --Lesions affecting >= 25% of body surface that may be confluent, necrotic, and/or hemorrhagicin appearance or cause sepsis --Disease resulting in airway compromise or affecting the nervous system --Cardiac (e.g., myocarditis) and/or neurologic disease (e.g., encephalitis) which might occur ina small number of patients with mpox --Ocular or periorbital infection, regardless of the time since infection onset Because the full scope of protracted or life-threatening mpxv infections is not known at this time, tecovirimat may also be considered on a case-by-case basis for an unusual situation wherein CDC consult team and/or CDC Principal Investigator in discussion with the treating clinician deem treatment under the EA-IND may potentially be beneficial; such consideration is expected to be rare and intended for unusual situations associated with disease that could result in clear long-term sequelae (e.g., urethral stricture). EXCLUSION CRITERIA: -Patient or legally authorized representative unwilling to sign an informed consent and refuse tecovirimat treatment -Known allergy to tecovirimat and/or inactive ingredients in tecovirimat -For IV tecovirimat only: patients with severe renal impairment (creatinine clearance <30 mL/min). Oral tecovirimat is an option for patients with severe renal impairment. -Patient or legally authorized representative is unwilling to sign an informed consent and/or refuses tecovirimat treatment. -Known allergy to tecovirimat and/or inactive ingredients in tecovirimat. -For IV tecovirimat only: patients with severe renal impairment (CrCl <30 mL/min). Oraltecovirimat is an option for patients with severe renal impairment. Note: IV tecovirimat has a labeled contraindication in patients with CrCl < 30 mL/min. Exceptions may be considered only if drug absorption via enteral administration is not anticipated to be dependable or feasible, and based on individual patient risk-benefit assessment by the treating clinician to determine IV tecovirimat as clinically necessary in consultation with CDC. In these instances, IV tecovirimat use must be with caution and close continuous monitoring of renalfunction.
-Patients with severely immunocompromised condition(s) defined as:
--HIV with CD4 < 200 cells/mm^3
--Leukemia or lymphoma
--Generalized malignancy
--Solid organ transplantation
--Therapy with alkylating agents within 180 days prior to mpox illness onset
--Antimetabolites within 180 days prior to mpox illness onset
--Radiation therapy within 180 days prior to mpox illness onset
--Tumor necrosis factor inhibitors within 180 days prior to mpox illness onset
--High-dose corticosteroids (equivalent of 20 mg or greater of prednisone for at least 14 days) within 90 days prior to mpox illness onset
--Being a recipient with hematopoietic stem cell transplant < 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 comparable severe immunocompromising condition
Persons with severe immunocompromise are known to be at high risk for protracted or life-threatening manifestations of mpox regardless of disease severity at presentation.
-Patients in the following categories:
a) Persons with active skin conditions placing the person at higher risk for disseminated infectiondefined as: atopic dermatitis; active exfoliative skin condition(s) such as eczema, burns, impetigo, active varicella zoster virus infection, psoriasis, or Darier disease (keratosisfollicularis)
b) Pregnant or lactating individuals, regardless of illness severity or underlying comorbidities at presentation
c) Children (< 18 years), regardless of illness severity or underlying comorbidities at presentation
These patients might be at high risk for protracted or life-threatening manifestations of mpox based on prior experience from other orthopoxvirus infections in humans.
-Patients with protracted or life-threatening manifestations of mpox at presentation as defined byone of the following:
--Lesions affecting >= 25% of body surface that may be confluent, necrotic, and/or hemorrhagicin appearance or cause sepsis
--Disease resulting in airway compromise or affecting the nervous system
--Cardiac (e.g., myocarditis) and/or neurologic disease (e.g., encephalitis) which might occur ina small number of patients with mpox
--Ocular or periorbital infection, regardless of the time since infection onset
Because the full scope of protracted or life-threatening mpxv infections is not known at this time, tecovirimat may also be considered on a case-by-case basis for an unusual situation wherein CDC consult team and/or CDC Principal Investigator in discussion with the treating clinician deem treatment under the EA-IND may potentially be beneficial; such consideration is expected to be rare and intended for unusual situations associated with disease that could result in clear long-term sequelae (e.g., urethral stricture).
EXCLUSION CRITERIA:
-Patient or legally authorized representative unwilling to sign an informed consent and refuse tecovirimat treatment
-Known allergy to tecovirimat and/or inactive ingredients in tecovirimat
-For IV tecovirimat only: patients with severe renal impairment (creatinine clearance <30 mL/min). Oral tecovirimat is an option for patients with severe renal impairment.
-Patient or legally authorized representative is unwilling to sign an informed consent and/or refuses tecovirimat treatment.
-Known allergy to tecovirimat and/or inactive ingredients in tecovirimat.
-For IV tecovirimat only: patients with severe renal impairment (CrCl <30 mL/min). Oraltecovirimat is an option for patients with severe renal impairment.
Note: IV tecovirimat has a labeled contraindication in patients with CrCl < 30 mL/min. Exceptions may be considered only if drug absorption via enteral administration is not anticipated to be dependable or feasible, and based on individual patient risk-benefit assessment by the treating clinician to determine IV tecovirimat as clinically necessary in consultation with CDC. In these instances, IV tecovirimat use must be with caution and close continuous monitoring of renalfunction.
Principal Investigator
Referral Contact
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