Clinical trial NCT06610643: Extended Remdesivir Infusion Combined With Nirmatrelvir/Ritonavir for Persistent SARS-CoV-2 Infection in Immunocompromised Patients
Official title: Extended Remdesivir Infusion Combined With Nirmatrelvir/Ritonavir for Persistent SARS-CoV-2 Infection in Immunocompromised Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COVID-19
SARS-CoV-2
Immunocompromised
Keywords: Extended RDV infusion combination therapy for SARS-CoV-2 infection in immunocompromised patients
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 \&amp;lt; 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 \&amp;lt; 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.

Primary outcomes:
measure: The proportion of SARS-CoV-2 CT &gt; 30 on Day 14
timeFrame: From enrollment to the end of treatment on Day 14.
Secondary outcomes:
measure: The proportion of mortality or respiratory failure requiring intubation and mechanical ventilation.
timeFrame: From enrollment to the end of treatment on Day 28.
measure: The proportion of patients developing anti-viral treatment emerging adverse events.
timeFrame: From enrollment to the end of treatment on Day 28.
measure: The proportion of secondary bacterial or fungal infection of each group.
timeFrame: From enrollment to the end of treatment on Day 28.
measure: The proportion of viral rebound within 28 days after antiviral agent initiation.
timeFrame: From enrollment to the end of treatment on Day 28.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: