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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination therapy | Experimental | combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir |
|
| SOC | Active Comparator | standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| combination therapy | Drug | A combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment on Day 14. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment on Day 28. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jann-Tay Wang, M. D., Ph.D. | Contact | +886-2-2312-3456 | 263517 | wangjt1124@ntuh.gov.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100225 | Taiwan |
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| SOC | Drug | Standard of care |
|
| The proportion of patients developing anti-viral treatment emerging adverse events. |
The proportion of patients developing anti-viral treatment emerging adverse events. |
| From enrollment to the end of treatment on Day 28. |
| The proportion of secondary bacterial or fungal infection of each group. | The proportion of secondary bacterial or fungal infection of each group. | From enrollment to the end of treatment on Day 28. |
| 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. | From enrollment to the end of treatment on Day 28. |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| C000606551 | remdesivir |
| C000718217 | nirmatrelvir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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