COVID-19, Immunocompromised, SARS-CoV-2
Conditions
Keywords
Extended RDV infusion combination therapy for SARS-CoV-2 infection in immunocompromised patients
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.
Interventions
DRUGcombination therapy
A combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir
DRUGSOC
Standard of care
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of SARS-CoV-2 CT > 30 on Day 14 | From enrollment to the end of treatment on Day 14. | The proportion of SARS-CoV-2 CT > 30 on Day 14 of each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of mortality or respiratory failure requiring intubation and mechanical ventilation. | From enrollment to the end of treatment on Day 28. | 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. | From enrollment to the end of treatment on Day 28. | The proportion of patients developing anti-viral treatment emerging adverse events. |
| The proportion of secondary bacterial or fungal infection of each group. | From enrollment to the end of treatment on Day 28. | The proportion of secondary bacterial or fungal infection of each group. |
| The proportion of viral rebound within 28 days after antiviral agent initiation. | From enrollment to the end of treatment on Day 28. | The proportion of viral rebound within 28 days after antiviral agent initiation of each group. |
Countries
Taiwan
Contacts
Primary ContactJann-Tay Wang, M. D., Ph.D.
Outcome results
None listed