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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05559099
Other study ID # PALM 007
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 10, 2022
Est. completion date September 2024

Study information

Verified date February 2024
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact Veronique Nussenblatt, MD ScM MHS
Phone +1-240-812-2075
Email veronique.nussenblatt@nih.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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. If a participant reaches full body lesion resolution but subsequently develops at least one new lesion consistent with mpox after discharge but while still enrolled in the study, they will be eligible to make a sick visit and will be offered standard of care for mpox.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tecovirimat Oral Capsule
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)
Placebo
Capsules to match tecovirimat

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

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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