Extended Remdesivir Infusion Combined With Nirmatrelvir/Ritonavir for Persistent SARS-CoV-2 Infection in Immunocompromised Patients

Not Applicable

Not yet recruiting

• Conditions: COVID-19; SARS-CoV-2; Immunocompromised
• Interventions: Drug: combination therapy; Drug: SOC

• Registration Number: NCT06610643
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-21
• Study First Submitted: 2024-09-22
• Study First Submitted QC: 2024-09-22
• Last Update Submitted: 2024-09-22
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combination therapy	combination therapy	combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir
combination therapy	SOC	combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir
SOC	SOC	standard of care

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan