Tecovirimat for Treatment of Monkeypox Virus
Primary Purpose
Monkeypox
Status
Recruiting
Phase
Phase 2
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
Tecovirimat Oral Capsule
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Monkeypox focused on measuring Monkeypox, MPXV
Eligibility Criteria
This study has no age restriction.
Inclusion Criteria:
- Laboratory-confirmed monkeypox infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
- Monkeypox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
- Weight ≥3 kg
Men and non-pregnant women of reproductive potential must agree to use effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. Acceptable methods of contraception include the following:
- Hormonal contraception
- Male or female condom
- Diaphragm or cervical cap with a spermicide
- Intrauterine device
- Stated willingness to comply with all study procedures (including required inpatient stay) and availability for the duration of the study
- Ability to provide informed consent personally or by a legally or culturally acceptable representative if the patient is unable to do so
Exclusion Criteria:
- Current or planned use of a meglitinide (repaglinide, nateglinide)
- Planned use of midazolam while on study drug
- Severe anemia, defined as hemoglobin <7 g/dL
- Current or planned use of another investigational drug at any point during study participation
- Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study
- Participants who are unable to safely swallow oral medications, such as those who are at risk of aspiration
Sites / Locations
- L'Hôpital Général de Référence de KoleRecruiting
- L'Hôpital Général de Référence de TundaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tecovirimat
Placebo
Arm Description
Tecovirimat capsules administered orally to participants for 14 days plus SOC.
Matching placebo capsules administered orally to participants for 14 days plus SOC.
Outcomes
Primary Outcome Measures
Time to lesion resolution
Number of days to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed.
Secondary Outcome Measures
Number of days to the first negative MPXV PCR test result
Measured by blood PCR tests
Mortality within the first 28 days post-randomization
Number of deaths post-randomization
Number of days to participant death
Number of days post-randomization
Frequency of solicited clinical symptoms
Clinical symptoms defined as: nausea, vomiting, abdominal pain, diarrhea, anorexia, cough, lymphadenopathy, dysphagia, sore throat, muscle aches, fatigue/lack of energy, fever, chills, night sweats, headache, ocular lesions, eye pain, change in vision, buccal ulcers, nasal congestion, cough, joint pain, pain with urination, painful skin lesions, pruritic skin lesions.
Duration of solicited clinical symptoms
Number of days
Incidence of serious adverse events requiring drug discontinuation
Number of SAEs
Incidence of adverse events requiring drug discontinuation
Number of AEs
Incidence of other adverse events
Number of AEs
Incidence of bacterial infections
Number of clinically defined bacterial infections. Laboratory and radiographical confirmation when possible.
Full Information
NCT ID
NCT05559099
First Posted
September 23, 2022
Last Updated
January 31, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
1. Study Identification
Unique Protocol Identification Number
NCT05559099
Brief Title
Tecovirimat for Treatment of Monkeypox Virus
Official Title
A Randomized, Placebo-controlled, Double-blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Adult and Pediatric Patients With Monkeypox Virus Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find out if tecovirimat is a safe and effective drug to treat monkeypox in combination with standard of care (SOC). Participants will be randomly assigned to receive oral tecovirimat plus SOC or placebo plus SOC for 14 days.
Detailed Description
This is a randomized, placebo-controlled, double-blind study to test the antiviral drug tecovirimat for the treatment of adults and children with laboratory-confirmed monkeypox virus (MPXV) disease at participating sites in the Democratic Republic of Congo. Eligible and consented participants will be randomized 1:1 to receive either oral tecovirimat or placebo, each administered in the hospital with standard-of-care (SOC) treatment for 14 days. Participants will be followed for 28 days with an optional visit at Day 59 for long-term assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monkeypox
Keywords
Monkeypox, MPXV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tecovirimat
Arm Type
Experimental
Arm Description
Tecovirimat capsules administered orally to participants for 14 days plus SOC.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsules administered orally to participants for 14 days plus SOC.
Intervention Type
Drug
Intervention Name(s)
Tecovirimat Oral Capsule
Other Intervention Name(s)
TPOXX
Intervention Description
200 mg capsules
Number of capsules and frequency of dosage will be based on participant weight:
≥120 kg: three capsules three times a day (total daily tecovirimat dose: 1,800 mg)
40 to <120 kg: three capsules twice a day (total daily tecovirimat dose: 1,200 mg)
25 to <40 kg: two capsules twice a day (total daily tecovirimat dose: 800 mg)
13 to <25 kg: one capsule twice a day (total daily tecovirimat dose: 400 mg)
6 to <13 kg: ½ the contents of a capsule twice daily (total daily tecovirimat dose: 200 mg)
3 to <6 kg: ¼ the contents of a capsule twice daily (total daily tecovirimat dose: 100 mg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules to match tecovirimat
Primary Outcome Measure Information:
Title
Time to lesion resolution
Description
Number of days to the first day on which all lesions on the total body are scabbed or desquamated or a new layer of epidermis has formed.
Time Frame
up to day 28
Secondary Outcome Measure Information:
Title
Number of days to the first negative MPXV PCR test result
Description
Measured by blood PCR tests
Time Frame
up to day 28
Title
Mortality within the first 28 days post-randomization
Description
Number of deaths post-randomization
Time Frame
up to day 28
Title
Number of days to participant death
Description
Number of days post-randomization
Time Frame
up to day 28
Title
Frequency of solicited clinical symptoms
Description
Clinical symptoms defined as: nausea, vomiting, abdominal pain, diarrhea, anorexia, cough, lymphadenopathy, dysphagia, sore throat, muscle aches, fatigue/lack of energy, fever, chills, night sweats, headache, ocular lesions, eye pain, change in vision, buccal ulcers, nasal congestion, cough, joint pain, pain with urination, painful skin lesions, pruritic skin lesions.
Time Frame
up to day 59
Title
Duration of solicited clinical symptoms
Description
Number of days
Time Frame
up to day 59
Title
Incidence of serious adverse events requiring drug discontinuation
Description
Number of SAEs
Time Frame
up to day 14
Title
Incidence of adverse events requiring drug discontinuation
Description
Number of AEs
Time Frame
up to day 14
Title
Incidence of other adverse events
Description
Number of AEs
Time Frame
up to day 28
Title
Incidence of bacterial infections
Description
Number of clinically defined bacterial infections. Laboratory and radiographical confirmation when possible.
Time Frame
up to day 28
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
This study has no age restriction.
Inclusion Criteria:
Laboratory-confirmed monkeypox infection as determined by PCR obtained from blood, oropharynx, or skin lesion within 48 hours of screening
Monkeypox illness of any duration provided that the patient has at least one active, not yet scabbed, lesion
Weight ≥3 kg
Men and non-pregnant women of reproductive potential must agree to use effective means of contraception when engaging in sexual activities that can result in pregnancy, from the time of enrollment through the end of study participation. Acceptable methods of contraception include the following:
Hormonal contraception
Male or female condom
Diaphragm or cervical cap with a spermicide
Intrauterine device
Stated willingness to comply with all study procedures (including required inpatient stay) and availability for the duration of the study
Ability to provide informed consent personally or by a legally or culturally acceptable representative if the patient is unable to do so
Exclusion Criteria:
Current or planned use of a meglitinide (repaglinide, nateglinide)
Planned use of midazolam while on study drug
Severe anemia, defined as hemoglobin <7 g/dL
Current or planned use of another investigational drug at any point during study participation
Patients who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study
Participants who are unable to safely swallow oral medications, such as those who are at risk of aspiration
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronique Nussenblatt, MD ScM MHS
Phone
+1-240-812-2075
Email
veronique.nussenblatt@nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Tshiani Mbaya, MD MTM&GH
Phone
+1-240-529-4773
Email
olivier.tshianimbaya@nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Muyembe-Tamfum, MD PhD
Organizational Affiliation
Kinshasa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
L'Hôpital Général de Référence de Kole
City
Kole
Country
Congo, The Democratic Republic of the
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Placide Mbala, MD PhD
Phone
+243 822851584
Email
mbalaplacide@gmail.com
First Name & Middle Initial & Last Name & Degree
Jules Alonga, MD
Phone
+243 825 123 351
Email
alongajules@gmail.com
Facility Name
L'Hôpital Général de Référence de Tunda
City
Tunda
Country
Congo, The Democratic Republic of the
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Placide Mbala, MD PhD
Phone
+243 822851584
Email
mbalaplacide@gmail.com
First Name & Middle Initial & Last Name & Degree
Freddy Yemba, MD
Phone
+243 81 533 48 79
Email
Fredyy@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Tecovirimat for Treatment of Monkeypox Virus
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