Tecovirimat for Monkeypox

(STOMP Trial)

Not currently recruiting at 84 trial locations

Overseen By ACTG Clinicaltrials.gov Coordinator

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Tecovirimat, Cabotegravir/Rilpivirine

Disqualifiers: Pregnancy, Severe risk, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 59

Duration: 14 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests tecovirimat, a potential treatment for monkeypox, to determine if it speeds up recovery. Researchers will compare tecovirimat to a placebo (a non-active treatment) to assess its effectiveness. The trial seeks individuals with lab-confirmed or suspected monkeypox, exhibiting symptoms like an active skin or mouth lesion that have persisted for no more than two weeks. Participants should not have previously taken tecovirimat and must agree to use contraception if they have reproductive potential. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to help bring a new treatment to market.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot start new intramuscular cabotegravir/rilpivirine during the study or for two weeks after. If you are already stable on these medications, you can still join the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tecovirimat has been studied for its safety in treating monkeypox. Early results from some studies suggest that people generally tolerate the treatment well. Although specific safety data on humans with monkeypox is lacking, only a few serious side effects have been reported. However, this information comes from passive monitoring, which might not capture all possible side effects.

Importantly, the FDA has already approved tecovirimat for treating smallpox, providing some confidence about its safety, as it has been thoroughly tested for that disease. However, specific safety details for monkeypox are still being collected in ongoing research.

In summary, while current data suggests tecovirimat is well-tolerated, more information is needed to fully understand its safety for treating monkeypox. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for monkeypox?

Tecovirimat is unique because it targets a specific protein in the monkeypox virus, inhibiting its ability to spread. Unlike standard treatments that mainly focus on symptom management, such as pain relievers and antivirals like cidofovir, tecovirimat directly interferes with the virus's replication process. Researchers are excited about this treatment because it offers a more targeted approach, potentially reducing the severity and duration of monkeypox infections compared to current options. This targeted mechanism of action could lead to more effective control of outbreaks.

What evidence suggests that tecovirimat might be an effective treatment for monkeypox?

Research shows that tecovirimat, which participants in this trial may receive, may help treat monkeypox. Early studies found that it can clear up skin sores and reduce symptoms without major side effects. Other research has observed improvements in the speed of symptom resolution and sore healing. Evidence also indicates that tecovirimat can lower the amount of virus in the body. These findings suggest that tecovirimat could effectively treat monkeypox. ^{1 3 5 6 7}

Who Is on the Research Team?

Timothy Wilkin, MD, MPH

Principal Investigator

Cornell

Are You a Good Fit for This Trial?

Adults (≥18 years) with confirmed or suspected Monkeypox virus infection, showing symptoms for less than 14 days and at least one active lesion. Must agree to use contraception if of reproductive potential. Children, severely ill patients, those with severe immunosuppression or skin conditions that increase risk are in a separate group.

Inclusion Criteria

Non-pregnant people of reproductive potential must agree to use at least one 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

Laboratory-confirmed or presumptive HMPXV infection

I have at least one active skin, mouth lesion, or proctitis.

Exclusion Criteria

I need tecovirimat through an IV.

I plan to start or continue cabotegravir/rilpivirine injections during or after the study.

Participants who, in the judgement of the investigator, will be at significantly increased risk as a result of participation in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tecovirimat or placebo for 14 days. Participants with severe disease or specific conditions receive open-label tecovirimat.

14 days

Weekly visits through day 29

Follow-up

Participants self-monitor lesions and symptoms daily through 29 days or until resolution. Weekly assessments for HMPXV disease and safety.

29 days

Weekly visits through day 29, additional visit on day 57

Long-term follow-up

Participants are assessed at day 57 for possible recrudescence of infection.

28 days after treatment

1 visit (in-person) on day 57

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tecovirimat

Trial Overview The study is testing the effectiveness of Tecovirimat capsules against Monkeypox compared to a placebo. Participants are randomly assigned to receive either the medication or placebo without knowing which they're getting. There's also an open-label part for certain participants.

How Is the Trial Designed?

Group I: Arm C Experimental Treatment 1 Intervention

Group II: Arm A Experimental Treatment 1 Intervention

Group III: Arm B Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

SIGA Technologist

Collaborator

Trials

1

Recruited

720+

SIGA Technologies

Industry Sponsor

Trials

11

Recruited

2,000+

Published Research Related to This Trial

This study will evaluate the efficacy and safety of oral tecovirimat in treating monkeypox and smallpox, involving 50 patients and focusing on the percentage of patients achieving negative PCR results for skin lesions after 14 days of treatment.

Participants will choose between receiving tecovirimat plus supportive treatment or only supportive treatment, with the study covering costs to ensure accessibility, highlighting a commitment to ethical research practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol of Tecopox study: a multicentre, open-label, double-arm trial to evaluate the efficacy and safety of oral tecovirimat therapy for patients with smallpox or monkeypox. Suzuki, T., Saito, S., Tsuzuki, S., et al.[2023]

Tecovirimat (ST-246) has been shown to be effective against the monkeypox virus (MPXV) isolate from the first clinical case in France, requiring only nanomolar concentrations for efficacy, which is significantly lower than the micromolar concentrations needed for cidofovir.

These findings support the ongoing use of tecovirimat in human clinical trials for treating monkeypox, highlighting its potential as a preferred treatment option during the current outbreak.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tecovirimat is effective against human monkeypox virus in vitro at nanomolar concentrations. Frenois-Veyrat, G., Gallardo, F., Gorgé, O., et al.[2023]

Tecovirimat (TPOXX®) is an antiviral drug specifically designed to target orthopoxviruses, including the variola virus that causes smallpox, by inhibiting a key protein necessary for the virus's spread within the host.

Approved in July 2018 for treating smallpox in patients weighing 13 kg or more, tecovirimat's efficacy was demonstrated through animal studies, allowing it to gain approval under the FDA's Animal Rule.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tecovirimat: First Global Approval. Hoy, SM.[2022]

Citations

1. cdc.gov cdc.gov/monkeypox/hcp/clinical-care/tecovirimat.html

Tecovirimat (TPOXX) for Treatment of Monkeypox Initial analysis of data from two randomized clinical studies designed to assess the efficacy and safety of a 14-day course of tecovirimat in treating human ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10389504/

Efficacy of smallpox approved tecovirimat (Tpoxx) drug ... The skin imperfections immediately disappeared, and the results revealed no significant negative effects9. Another report documented mild ...

3. evidence.nejm.org evidence.nejm.org/doi/full/10.1056/EVIDoa2400189

Tecovirimat Use under Expanded Access to Treat Mpox in the ... Multiple clinical trials are underway to evaluate the effectiveness of tecovirimat; preliminary data from one of the studies (PALM007) was ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jmv.70122

Effectiveness of Tecovirimat in Mpox Cases: A Systematic ... Some studies report promising results regarding symptom resolution, lesion healing, and the reduction of viral load, particularly when ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05597735

Study Details | NCT05597735 | Assessment of the Efficacy ... This study aims to evaluate whether tecovirimat is an efficient and safe antiviral in the treatment of monkeypox in adults and adolescents (14 years old and ...

6. cdc.gov cdc.gov/mmwr/volumes/71/wr/mm7137e1.htm

Clinical Use of Tecovirimat (Tpoxx) for Treatment ... ... data obtained from animal models; there are no safety or efficacy data regarding its use in patients with Monkeypox virus infection. What is ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9765296/

Tecovirimat for Treatment of Human Monkeypox Virus - PMC Therefore, all dosing recommendations for children are based on pharmacokinetic simulations, and no safety data exist. Recommended dosing is ...