Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202405860723287 Date of Approval: 27/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A phase III, multi-country, randomized, placebo-controlled, double-blinded adaptive platform trial to assess the efficacy and safety of treatments for participants with monkeypox virus disease
Official scientific title A phase III, multi-country, randomized, placebo-controlled, double-blinded adaptive platform trial to assess the efficacy and safety of treatments for participants with monkeypox virus disease
Brief summary describing the background and objectives of the trial The World Health Organization (WHO) calls for the use of antivirals for the treatment of monkeypox cases within a framework of collaborative research1 and randomized clinical trial (RCT) protocols with standardized data collection tools for clinical and outcome data to rapidly increase evidence generation on efficacy and safety. A platform trial uses a shared infrastructure, in which various treatments are evaluated using the same ‘CORE protocol’2 and tested against a shared control condition. Moreover, the speed of platform trials might help to accelerate the evaluation of drugs and generate evidence from different subgroups and different geographic locations. This is a Master protocol based on an international ‘CORE protocol2 developed by WHO for an international randomized, placebo-controlled trial to evaluate the safety and efficacy of antiviral drugs for the treatment of human monkeypox (Phase 3). Study sites will be in geographic locations where cases of monkeypox were reported. Sites will be opened one after another as they obtain approvals and are ready to start the trial. Randomization will be used to balance the groups with respect to many known and unknown confounding or prognostic variables. The use of a placebo control group will enable a reliable assessment of efficacy and safety of the experimental treatment. To enhance trial integrity, the study was designed to be double blinded. The primary objective is to evaluate the clinical efficacy, as assessed by time to lesion(s) resolution in participants with mpox. The second objectives to evaluate the safety and efficacy, as assessed by mortality, hospitalization, complications, duration of symptoms in participants with mpox.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MOSA
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Monkeypox
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/09/2024
Actual trial start date
Anticipated date of last follow up 30/06/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 422
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo o 13 kg to less than 25 kg: 200 mg 12 hours for 14 days (one placebo 200 mg capsules) o ≥>25 kg to less than 40 kg: 400 mg every 12 hours for 14 days (two placebo 200 mg capsules) o ≥>40 kg and less than 120 kg: 600 mg every 12 hours for 14 days (three placebo 200 mg capsules) o 120 kg or more, 600 mg (three placebo 200 mg capsules), three times daily every 8 hours for 14 days 14 days Oral administration within 30 minutes of a meal of moderate or high fate. Follow-up visits will occur on Day 3, Day 7, Day 10, Day 14, Day 17, Day 21, Day 24 with a last end of study visit on Day 28. During these visits: vital signs, symptoms and signs compatible with MPX, pain scale, blood samples for laboratory tests, treatment compliance will be collected 211 Placebo
Experimental Group Tecovirimat o 13 kg to less than 25 kg: 200 mg (one tecovirimat 200 mg capsule), twice daily every 12 hours for 14 days o 25 kg to less than 40 kg: 400 mg (two tecovirimat 200 mg capsules), twice daily every 12 hours for 14 days o 40 kg and less than 120 kg: 600 mg (three tecovirimat 200 mg capsules), twice daily every 12 hours for 14 days o 120 kg or more 600 mg (three tecovirimat 200 mg capsules), three times daily every 8 hours for 14 days 14 days Oral administration within 30 minutes of a meal of moderate or high fate. Follow-up visits will occur on Day 3, Day 7, Day 10, Day 14, Day 17, Day 21, Day 24 with a last end of study visit on Day 28. During these visits: vital signs, symptoms and signs compatible with MPX, pain scale, blood samples for laboratory tests, treatment compliance will be collected 211
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Signed informed consent or assent for minor participants 2. Adults with positive monkeypox virus PCR confirmed within 7 days of Day 1 3. Children above 13kg with positive monkeypox virus PCR confirmed within 7 days of Day 1 (only applicable Tecovirimat/placebo arms) 4. At least one visible active skin or mucosal lesion 1. Current or planned use of another investigational drug at any point during study participation. 2. Ongoing treatment which cannot be interrupted and for which a major interaction has been described with IP. 3. ParticipantSubjects who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study (for example: if the investigator judges that an antiviral treatment is not indicated). 4. Known hypersensitivity to a substance in the IP. 5. Use of concomitant medications that are contraindicated with IP 6. Unwilling or unable to comply with the requirements of the study protocol at any time during the study. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 24 Month(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/06/2024 25/09/2023 Comite National d Ethique de la sante
Ethics Committee Address
Street address City Postal code Country
Commune Kasa Vubu Kinshasa 48035 Congo
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 13/01/2025 National Health Research Ethics Committee of NIgeria
Ethics Committee Address
Street address City Postal code Country
Federal Ministry of Health Federal Secretariat Complex Shehu Shagari Way Garki Abuja PMB083 Nigeria
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 13/01/2025 Comite National d Ethique pour la Recherche en Sante Humaine
Ethics Committee Address
Street address City Postal code Country
Hygiene Mobile Messa Yaounde BP Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome time for all visible lesions (skin, mucosal or rectal) to heal with a new fresh layer of skin re-epithelialization (i.e. resurfacing of a wound) with a new epithelium layer (up to visit Day 28) during the study, up to visit DAY 28
Secondary Outcome • All-cause mortality within the first 28 days (applied to all subjectsparticipants) • All-cause unplanned admission to hospital within first 28 days (applies to outpatients) • Occurrence of subjectsparticipants with a complication within first 28 days (applies to all subjectsparticipants who did not already have a complication at baseline) • Time to resolution of symptoms and signs within first 28 days (applies to all subjectsparticipants) • Frequency of adverse events (AEs) and serious adverse events (SAEs) and proportion of drug discontinuation during the study, up to DAY 28
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
INFECTIOUS DESEASES DEPARTMENT YAOUNDE CENTRAL HOSPITAL Rue Henri Dunant Yaounde PO BOX 87 Cameroon
Universite de Kinshasa Faculte de Medicine Departement de Medecine Tropicale Commune Lemba Kinshasa BP 127 Congo
Nigeria Centre for Disease Control 801 Ebitu Ukiwe St Abuja 900108 Nigeria
Congolese Foundation for Medical Research Center for Research on Infectious Diseases Cite de l OMS Afrique Brazzaville PO BOX 06 Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
Multiple Not applicable not applicable France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PANTHER 2 rue d Oradour sur Glane Paris 75015 France Non for profit
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Nathalie Strub Wourgaft nstrub-wourgaft@pantherhealth.org 0033658277226 2 rue d Oradour sur Glane
City Postal code Country Position/Affiliation
Paris 75015 France General Delegate
Role Name Email Phone Street address
Principal Investigator Nathalie Strub Wourgaft nstrub-wourgaft@pantherhealth.org 0033658277226 2 rue d Oradour sur Glane
City Postal code Country Position/Affiliation
Paris 75015 France General Delegate
Role Name Email Phone Street address
Scientific Enquiries Nathalie Strub Wourgaft nstrub-wourgaft@pantherhealth.org 0033658277226 2 rue d Oradour sur Glane
City Postal code Country Position/Affiliation
Paris 75015 France General Delegate
Role Name Email Phone Street address
Principal Investigator Hermine Abessolo drabesso@yahoo.fr +23793058757 YAOUNDE CENTRAL HOSPITAL INFECTIOUS DESEASES DEPARTMENT
City Postal code Country Position/Affiliation
Yaounde POBox 87 Cameroon Principal Investigator
Role Name Email Phone Street address
Principal Investigator Van Kawaya vankawaya2017@gmail.com +234817294033 Universite de Kinshasa Faculte de Medicine Departement de Medecine Tropicale Commune Lemba Mont Amba
City Postal code Country Position/Affiliation
Kinshasa Congo Principal Investigator Congo
Role Name Email Phone Street address
Principal Investigator Dimie Ogoina dimieogoina@gmail.com +2348034510717 Nigeria Centre for Disease Control 801 Ebitu Ukiwe St Jabi
City Postal code Country Position/Affiliation
ABUJA 900108 Nigeria Principal Investigator NIgeria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes In the informed consent form the following information is available: You have the right to receive information on the results of the study once the study is finished. Ask the study doctor or a member of the study personnel how to arrange to receive this information. Your coded personal information may be used and processed for other scientific research on monkeypox or other coinfections, still in accordance with the applicable laws and regulations, unless you object to this. Informed Consent Form within 1 year of the study completion controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information