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

National Taiwan University

Status: Not yet enrolling

Conditions: COVID-19; SARS-CoV-2; Immunocompromised

Treatments: Drug: SOC; Drug: combination therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06610643

202405064MIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

combination therapy

Experimental group

Description:

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

Treatment:

Drug: combination therapy

Drug: SOC

SOC

Active Comparator group

Description:

standard of care

Treatment:

Drug: SOC