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

N/ANot Yet RecruitingNCT06610643

National Taiwan University Hospital40 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19 SARS-CoV-2 Immunocompromised

Interventions

combination therapyDRUG

A combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir

SOCDRUG

Standard of care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 \&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 \&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.

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: From enrollment to the end of treatment on Day 14.

Secondary Outcomes

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.

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.

The proportion of viral rebound within 28 days after antiviral agent initiation of each group.

Time frame: From enrollment to the end of treatment on Day 28.

Central Contacts

Jann-Tay Wang, M. D., Ph.D.

CONTACT

+886-2-2312-3456 wangjt1124@ntuh.gov.tw

Data from ClinicalTrials.gov

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