To evaluate the safety and efficacy of extended remdesivir infusion, targeting onimmunocompromised individuals who had positive SARS-CoV-2 PCR despite an oral antiviralagent prescription.
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.
Drug: combination therapy
A combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir
Other Name: remdesivir and Nirmatrelvir/Ritonavir
Drug: SOC
Standard of care
Inclusion Criteria:
- Age ≥ 18 years
- Receive B-cell depletion therapy or bendamustine within 6months
- Laboratory confirmed SARS-CoV-2 infection
- Symptoms onset within 72 hours
- NIAID ordinal score 0-5 upon enrollment
Exclusion Criteria:
- Prior use of any anti-SARS-CoV-2 agents within 2 weeks. Remdesivir or NMV/r
initiated within 24 hours is acceptable
- Life expectancy < 1 month
- Previous adverse effect related to remdesivir or NMV/r
- Concurrent use medicine with drug-drug interaction with NMV/r
- Patients receiving intubation and mechanical ventilation
- eGFR < 30
- Child pugh score Class C
- Any other condition that in the opinion of the investigator would jeopardize the
safety or rights of a subject participating in the trial or would render the subject
unable to comply with the protocol.
National Taiwan University Hospital
Taipei, Taiwan
Investigator: Fu-Chang Tsai, Professor
Contact: +886-2312-3456
fctsai@ntu.edu.tw
Jann-Tay Wang, M. D., Ph.D.
+886-2-2312-3456 - 263517
wangjt1124@ntuh.gov.tw
Not Provided