Extended Remdesivir Infusion Combined With Nirmatrelvir/Ritonavir for Persistent SARS-CoV-2 Infection in Immunocompromised Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: combination therapy, SOC.
- Who it may be relevant to
- Registry conditions: COVID-19, SARS-CoV-2, Immunocompromised. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 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.
Interventions
- Drug combination therapy
A combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir - Drug SOC
Standard of care
Primary outcome measures
- The proportion of SARS-CoV-2 CT > 30 on Day 14 [Time frame: From enrollment to the end of treatment on Day 14.]
Secondary outcome measures (4)
- The proportion of mortality or respiratory failure requiring intubation and mechanical ventilation. [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. [Time frame: From enrollment to the end of treatment on Day 28.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT06610643 · 202405064MIND