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Antiviral

Tecovirimat for Monkeypox (PLATINUM-CAN Trial)

Phase 3
Recruiting
Research Sponsored by Marina Klein
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sexual contact with 1 or more persons in the 21 days prior to symptom onset or any person with known close exposure to another person known to be infected with monkeypox infection. Presence of active skin or mucosal lesion(s).
Appropriate to be managed without hospitalization.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights

PLATINUM-CAN Trial Summary

This trial is testing a drug called Tecovirimat in non-hospitalized patients with monkeypox infection. The goal is to see if Tecovirimat is effective and safe in treating monkey

Who is the study for?
This trial is for adults over 18 years old, weighing at least 40 kg, with confirmed or suspected monkeypox infection based on PCR tests or visible symptoms. Participants should have had sexual contact within the last 21 days or exposure to someone with monkeypox and must be able to manage their condition without hospitalization.Check my eligibility
What is being tested?
The PLATINUM-CAN trial is testing Tecovirimat against a placebo in non-hospitalized patients with monkeypox. It's randomized, meaning people are put into the Tecovirimat or placebo group by chance, and aims to find out how effective and safe Tecovirimat is for treating monkeypox outside of hospitals.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed here, common side effects of antiviral drugs like Tecovirimat can include headache, nausea, stomach pain, fatigue and sometimes more serious reactions depending on individual health conditions.

PLATINUM-CAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've had sexual contact recently and have skin or mucosal lesions.
Select...
I can be treated without needing to stay in the hospital.
Select...
I weigh at least 40 kg.

PLATINUM-CAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility and acceptability of conducting a pragmatic phase 3 interventional trial for outpatients with Monkeypox in Canada
Time to active lesion resolution
Secondary outcome measures
Secondary feasibility outcomes
Time to complete lesion resolution
Time to negative skin or mucosa swab viral culture
+1 more
Other outcome measures
Assessment of safety
Clinical status
Hospitalization rates
+5 more

Side effects data

From 2016 Phase 3 trial • 449 Patients • NCT02474589
17%
Headache
6%
Nausea
3%
Diarrhoea
3%
Dizziness
3%
Vomiting
2%
Abdominal Pain Upper
2%
Nasopharyngitis
1%
Arthralgia
1%
Rash
1%
Fatigue
1%
Muscle Strain
1%
Dyspepsia
1%
Depression
1%
Nervousness
1%
Myalgia
1%
Ligament Sprain
1%
Ear Pain
1%
Pruritis
1%
Somnolence
1%
Migraine
1%
Constipation
1%
Dry Mouth
1%
Chills
1%
Abdominal Distention
1%
Pyrexia
1%
Pain
1%
Blood Pressure Systolic Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active
Placebo

PLATINUM-CAN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TecovirimatExperimental Treatment1 Intervention
Tecovirimat (TPOXX®) Capsules, 200 mg (as tecovirimat monohydrate) administered as 600 mg (three 200 mg capsules) taken twice daily orally, every 12 hours, within 30 minutes after a full meal of moderate or high fat (approximately 25 g of fat) for 14 days
Group II: PlaceboPlacebo Group1 Intervention
Identical placebo supplied by SIGA Technologies Inc.

Find a Location

Who is running the clinical trial?

University of British ColumbiaOTHER
1,418 Previous Clinical Trials
2,466,998 Total Patients Enrolled
Unity Health TorontoOTHER
540 Previous Clinical Trials
447,660 Total Patients Enrolled
1 Trials studying Monkeypox
250 Patients Enrolled for Monkeypox
Marina KleinLead Sponsor
1 Previous Clinical Trials
76 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing opportunities for patients to participate in this clinical trial at the moment?

"Indeed, the details on clinicaltrials.gov demonstrate that this investigation is actively seeking suitable participants. The trial was initially disclosed on August 14th, 2023, with its most recent update made on February 28th, 2024. At present, the study aims to recruit a total of 120 individuals from three distinct sites."

Answered by AI

Has Tecovirimat received approval from the FDA?

"Based on the information provided, our team at Power rates Tecovirimat's safety as a 3 on the scale. This assessment is influenced by the Phase 3 trial status which signifies partial efficacy evidence and robust safety data from multiple iterations."

Answered by AI

What is the current number of individuals being included in this clinical trial?

"Yes, information on clinicaltrials.gov highlights that this research is presently in search of volunteers. The initial posting date was 8/14/2023, with the latest update recorded on 2/28/2024. A total of 120 participants are sought across three distinct sites."

Answered by AI

What are the main goals and purposes of this clinical investigation?

"The primary aim of this investigation, to be assessed within an approximate time frame extending up to 28 days from randomization, is to evaluate the feasibility and acceptability of executing a pragmatic phase 3 intervention trial for outpatients affected by Monkeypox in Canada. Secondary objectives comprise measuring the duration required for complete lesion resolution (defined as the number of days until all lesions have fully healed), determining the timeframe needed for throat swab viral culture results to consistently show negative readings for monkeypox virus, and assessing additional feasibility metrics such as adherence rates exceeding 85% on daily questionnaires and self-sampling practices, alongside tracking participant capability in"

Answered by AI
~13 spots leftby Jun 2024