A Phase 3 interventional study of sirolimus and oseltamivir and Oseltamivir in Influenza, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-27.
Sponsored by Chinese University of Hong Kong · Phase 3, Interventional, and Treatment
Seasonal influenza epidemics are important causes of mortality and morbidity. Cytokine dysregulation, with high levels of pro-inflammatory cytokines, occurs in patients with severe influenza A(H1N1)pdm09 virus infection, A(H5N1) infection, and A(H7N9) infection. We aim to investigate the effects of adjunctive sirolimus in adults hospitalized with influenza A or B infections involving the lower respiratory tract.
The investigators aim to investigate the effects of adjunctive sirolimus in adults hospitalized with influenza A or B infections involving the lower respiratory tract. Patients will be randomized to either oseltamivir and adjunctive sirolimus or oseltamivir alone and assessed with reference to normalization of respiratory status (SaO2 ≥93% or respiratory rate ≤20/min on room air) as the primary endpoint,10 cytokines/chemokines and pro-inflammatory mediator changes, viral clearance, symptom resolution, ICU admission/death, day 28 mortality; safety profiles will also be assessed.
The investigators hypothesize that addition of sirolimus to oseltamivir would improve respiratory status and other endpoints more effectively than oseltamivir alone through reduction of inflammatory responses without affecting viral clearance.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's planned enrollment of 160 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Sirolimus 1 mg daily and oseltamivir 75 mg bid for 5 days, both given orally. Extension of dosing to 10 days for oseltamivir and the study drug is allowed if there is slow recovery, lack of improvement, or deterioration.
Drug: sirolimus and oseltamivir
oral oseltamivir 75 mg bid alone for 5 days. Extension of dosing to 10 days for oseltamivir and the study drug is allowed if there is slow recovery, lack of improvement, or deterioration.
Drug: Oseltamivir
Sirolimus 1 mg daily and oseltamivir 75 mg bid for 5 days, both given orally. Extension of dosing to 10 days for oseltamivir and the study drug is allowed if there is slow recovery, lack of improvement, or deterioration.
oral oseltamivir 75 mg bid alone for 5 days. Extension of dosing to 10 days for oseltamivir and the study drug is allowed if there is slow recovery, lack of improvement, or deterioration.
normalisation of respiratory status
SaO2 ≥93% or respiratory rate ≤20/min on room air
Time frame: 28 days
viral ribonucleic acid (RNA) in copies per milliliter
All serially collected samples will be subjected to viral ribonucleic acid (RNA) quantification using quantitative reverse transcription PCR (qRTPCR) targeting the matrix (M)-gene ('viral load')
Time frame: 28 days
Interleukin 6 in pg/ml
Time frame: 10 days
interleukin-8 in pg/ml
Time frame: 10 days
interleukin 17 in pg/ml
Time frame: 10 days
Chemokine ligand 9 (CxCL9/MIG) in pg/ml
Time frame: 10 days
Soluble tumour necrosis factor receptor-1 (sTNFR-1) in pg/ml
Time frame: 10 days
interleukin 18 in pg/ml
Time frame: 10 days
CRP in mg/L
Time frame: 10 days
phospho-p38 and phospho-ERK (activated MAPKs) in mean fluorescence intensity(MFI)
Time frame: 10 days
phospho-inhibitor kB/IkB (NF-kB) in mean fluorescence intensity(MFI)
Time frame: 10 days
resolution of symptoms in days
A standard questionnaire will be used to collect baseline and serial clinical data. These include clinical manifestations/complications, symptom severity score, vital signs (e.g. temperature, respiratory rate, oxygen saturation), fever duration, requirements for supplemental oxygen therapy and invasive/non-invasive ventilation, duration of hospitalization, death, and occurrence of adverse events.
Time frame: 28 days
ICU admission in days
Time frame: 28 days
mortality in days
Time frame: 28 days
Incidence of Treatment-Emergent Adverse Events in numbers
Time frame: 28 days
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Chinese University of Hong Kong