Status:
NOT_YET_RECRUITING
Extended Remdesivir Infusion Combined With Nirmatrelvir/Ritonavir for Persistent SARS-CoV-2 Infection in Immunocompromised Patients
Lead Sponsor:
National Taiwan University Hospital
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
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 cl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06610643
Start Date
September 21 2024
End Date
December 31 2026
Last Update
September 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, Taiwan, 100225