About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Receive B-cell depletion therapy or bendamustine within 6months
Laboratory confirmed SARS-CoV-2 infection
Symptoms onset within 72 hours
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
combination therapy
DrugA combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir
SOC
DrugStandard of care
Treatment groups
Trial outcomes
Primary outcomes
The proportion of SARS-CoV-2 CT > 30 on Day 14
The proportion of SARS-CoV-2 CT \> 30 on Day 14 of each group.
Secondary outcomes
The proportion of mortality or respiratory failure requiring intubation and mechanical ventilation.
The proportion of mortality or respiratory failure requiring intubation and mechanical ventilation within 28 days after antiviral agent initiation of each group.
The proportion of patients developing anti-viral treatment emerging adverse events.
The proportion of patients developing anti-viral treatment emerging adverse events.
The proportion of secondary bacterial or fungal infection of each group.
The proportion of secondary bacterial or fungal infection of each group.
The proportion of viral rebound within 28 days after antiviral agent initiation.
The proportion of viral rebound within 28 days after antiviral agent initiation of each group.
Sponsors and contacts
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