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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

About this trial

This is an interventional treatment trial for Monkeypox focused on measuring Monkeypox, MPXV

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

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

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

mbalaplacide@gmail.com

First Name & Middle Initial & Last Name & Degree

Jules Alonga, MD

Phone

+243 825 123 351

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

mbalaplacide@gmail.com

First Name & Middle Initial & Last Name & Degree

Freddy Yemba, MD

Phone

+243 81 533 48 79

Fredyy@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Tecovirimat for Treatment of Monkeypox Virus

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