Combining sirolimus with oseltamivir for treating severe influenza
A Randomized Controlled Trial of Adjunctive Sirolimus and Oseltamivir Versus Oseltamivir Alone for Treatment of Influenza
PHASE3 · Chinese University of Hong Kong · NCT03901001
This study is testing if adding sirolimus to the usual flu medicine oseltamivir can help adults in the hospital with severe influenza breathe better and recover faster.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT03901001 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of adding sirolimus to oseltamivir in adults hospitalized with severe influenza A or B infections affecting the lower respiratory tract. Participants will be randomly assigned to receive either oseltamivir alone or oseltamivir with sirolimus. The primary endpoint is the normalization of respiratory status, alongside assessments of cytokine levels, viral clearance, symptom resolution, and safety profiles. The hypothesis is that sirolimus will enhance treatment efficacy by reducing inflammatory responses without hindering viral clearance.
Who should consider this trial
Good fit: Ideal candidates are adults hospitalized with confirmed influenza A or B infections and clinical evidence of lower respiratory tract involvement.
Not a fit: Patients with known immunocompromised conditions or those on other immunosuppressants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved respiratory outcomes and reduced mortality in patients with severe influenza.
How similar studies have performed: Other studies have explored adjunctive therapies for influenza, but the specific combination of sirolimus and oseltamivir is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * influenza A and B virus infections confirmed by PCR and/or immunofluorescence assays, hospitalized for the management of severe manifestations of influenza, initiation of oseltamivir, clinical evidence of lower respiratory tract infection (e.g. shortness of breath, tachypnea, oxygen desaturation, crepitations on auscultation, infiltrations or consolidations on chest radiograph) and written informed consent (by the subjects, or from their next of kin if the subjects are unable to provide written consent at the time of enrollment) Exclusion Criteria: * use of other immunosuppressants (e.g. post-chemotherapy, post-transplant, autoimmune diseases) other than systemic corticosteroids * patients with known immuno-compromised conditions (e.g. active haematological malignancies, HIV/AIDS patients who are on antiretroviral therapy and CD4 cell count \< 200) * pregnancy/lactation * hepatic failure * patients with surgery done/planned within 1 month * patients who have received macrolide antibiotics and NSAID for 1 week prior to enrolment due to their immuno-modulating effects * patients on drugs that may interact and alter sirolimus level (rifampicin, azole antifungals, phenytoin, diltiazem, verapamil, nicardipine, metoclopramide, phenobarbital, carbamazepine) will be excluded for safety purposes * Use of investigational anti-influenza antivirals and blood products
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: David SC Hui — Chinese University of Hong Kong
- Study coordinator: Ken Ka Pang Chan, MBChB
- Email: chankapang@cuhk.edu.hk
- Phone: 3505 3532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Influenza, respiratory, Mortality, cytokines, chemokines