Monkeypox Clinical Trial
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
The purpose of this study is to find out if tecovirimat is a safe and effective drug to treat monkeypox (mpox) 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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | September 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | This study has no age restriction. Inclusion Criteria: - Laboratory-confirmed monkeypox virus 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 |
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic of the | L'Hôpital Général de Référence de Kole | Kole | |
Congo, The Democratic Republic of the | L'Hôpital Général de Référence de Tunda | Tunda |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo |
Congo, The Democratic Republic of the,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | up to day 28 | |
Secondary | Time to lesion resolution for participants with symptom onset less than or equal to 7 days before randomization | 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. | up to day 28 | |
Secondary | Time to lesion resolution for participants with symptom onset greater than 7 days before randomization | 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. | up to day 28 | |
Secondary | Number of participants with negative blood PCR results | Proportion of participants with negative blood sample MPXV PCR results 14 days post-randomization | day 14 | |
Secondary | Number of participants with negative oropharyngeal swab PCR results | Proportion of participants with negative oropharyngeal swab MPXV PCR results 14 days post-randomization | day 14 | |
Secondary | Number of participants with negative lesion swab PCR results | Proportion of participants with negative lesion swab MPXV PCR results 14 days post-randomization | day 14 | |
Secondary | Mortality within the first 28 days post-randomization | Number of deaths post-randomization | up to day 28 | |
Secondary | Number of days to participant death | Number of days post-randomization | up to day 28 | |
Secondary | 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. | up to day 59 | |
Secondary | Duration of solicited clinical symptoms | Number of days | up to day 59 | |
Secondary | Incidence of serious adverse events requiring drug discontinuation | Number of SAEs | up to day 14 | |
Secondary | Incidence of adverse events requiring drug discontinuation | Number of AEs | up to day 14 | |
Secondary | Incidence of other adverse events | Number of AEs | up to day 28 | |
Secondary | Incidence of bacterial infections | Number of clinically defined bacterial infections. Laboratory and radiographical confirmation when possible. | up to day 28 |
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