National Taiwan University Hospital
Taipei, 100225, Taiwan
NCT Number: NCT06610643
To evaluate the safety and efficacy of extended remdesivir infusion, targeting on immunocompromised individuals who had positive SARS-CoV-2 PCR despite an oral antiviral agent prescription.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Taipei, 100225, Taiwan
Prolonged viral shedding is commonly observed in immunocompromised patients infected by SARS-CoV-2. Until now, there is no successful clinical trial or guideline to guide optimal treatment for this clinical condition. Here, we aimed to establish a clinical trial with combination of prolonged remdesivir infusion with nirmatrelvir/ritonavir among COVID-19 patients recently receiving b-cell depletion therapy, to evaluate to clinical outcomes.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir
Other names: remdesivir and Nirmatrelvir/Ritonavir
Standard of care
Time frame: From enrollment to the end of treatment on Day 14.
The proportion of SARS-CoV-2 CT > 30 on Day 14 of each group.
Time frame: From enrollment to the end of treatment on Day 28.
The proportion of mortality or respiratory failure requiring intubation and mechanical ventilation within 28 days after antiviral agent initiation of each group.
Time frame: From enrollment to the end of treatment on Day 28.
The proportion of patients developing anti-viral treatment emerging adverse events.
Time frame: From enrollment to the end of treatment on Day 28.
The proportion of secondary bacterial or fungal infection of each group.
Time frame: From enrollment to the end of treatment on Day 28.
The proportion of viral rebound within 28 days after antiviral agent initiation of each group.
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
Acronym: SARS-CoV-2
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