Compassionate use of tocilizumab in hantavirus pulmonary syndrome: a pre- and post-study

Not Applicable

• Conditions: Hantavirus pulmonary syndrome; Respiratory

• Registration Number: ISRCTN72088243
• Lead Sponsor: Ministerio de Salud de Rio Negro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-26
• Last Update Posted: 8 July 2024
• Study Completion: 2029-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Diagnosis confirmation: participants must be clinically diagnosed with Hantavirus Pulmonary Syndrome. Diagnosis should be confirmed through one or more of the following:
1.1. Detection of hantavirus-specific IgM antibodies in serum.
1.2. A four-fold rise in hantavirus-specific IgG antibody titers in paired serum samples.
1.3. Positive RT-PCR test for hantavirus RNA in blood or tissue samples.
2. Age: participants must be aged 18 years or older. This age criterion ensures that all participants can legally consent to the study and are within the adult age range most commonly affected by HPS.
3. Severity of condition: participants must be exhibiting symptoms severe enough to require hospitalization, ensuring the study targets those most likely to benefit from tocilizumab treatment.
4. Ability to provide informed consent: participants must be capable of giving informed consent or have a legal guardian who can consent on their behalf if they are incapacitated.
5. Treatment window: participants must be eligible to receive the study intervention (tocilizumab) within 24 hours of hospital admission to ensure the treatment is administered in a timely manner, which is critical for its potential efficacy.
6. Health status: participants must have no known allergies to tocilizumab or its excipients.
7. No severe co-morbid conditions that could interfere with the study outcomes or significantly increase the risk of adverse effects from tocilizumab, such as severe chronic liver disease, known active tuberculosis, or other severe active infections.
8. No prior treatment: participants must not have received tocilizumab or other investigational treatments for HPS before enrollment in this study to ensure that any observed effects can be attributed to the study drug.

Exclusion Criteria

1. Previous treatment with tocilizumab or related therapies: participants who have previously received tocilizumab or other monoclonal antibodies targeting IL-6 or IL-6 receptors for any condition.
2. Severe allergic reactions: individuals with a history of severe allergic reactions to tocilizumab or any of its excipients.
3. Active or latent infections: participants with active, severe infections at the time of screening, such as tuberculosis, HIV, or hepatitis.
4. Individuals with a known history of chronic or recurrent infections.
5. Pregnancy or lactation: pregnant or breastfeeding women due to the unknown effects of tocilizumab on fetuses or infants.
6. Severe comorbid conditions: individuals with uncontrolled cardiovascular, liver, renal, or metabolic diseases that could complicate treatment outcomes.
7. Patients with a known history of gastrointestinal perforation within the last 6 months.
8. Recent vaccinations: participants who have received live vaccines within 30 days prior to the intended start of treatment.
9. Participation in other clinical trials: individuals currently participating in another clinical trial or who have participated in a clinical trial involving an investigational product within the last 30 days.
10. Substance abuse: current or recent (within the last year) history of significant alcohol or drug abuse that could interfere with adherence to study protocols.
11. Immunosuppression: patients with conditions or on treatments that significantly suppress immune function, such as chemotherapy or high-dose corticosteroids.
12. Psychiatric illness: individuals with psychiatric illnesses or conditions that could interfere with their ability to understand or comply with the requirements of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality measured using medical records at 28 days post-intervention

Secondary Outcome Measures

Name	Time	Method
1. Incidence of mechanical ventilation measured using medical records at the time of hospital admission, daily during hospital stay, and at discharge<br>2. Duration of mechanical ventilation, measured using medical records from the initiation to the cessation of mechanical ventilation during the hospital stay<br>3. Incidence of inotropic support measured using medical records at the time of hospital admission, daily during hospital stay, and at discharge