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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Receive B-cell depletion therapy or bendamustine within 6months

Laboratory confirmed SARS-CoV-2 infection

Symptoms onset within 72 hours

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • combination therapy

    Drug

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

  • SOC

    Drug

    Standard of care

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: combination therapyExperimental treatment 2 interventions
Group B: SOCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.
2

The proportion of patients developing anti-viral treatment emerging adverse events.

The proportion of patients developing anti-viral treatment emerging adverse events.

Time frame
From enrollment to the end of treatment on Day 28.
3

The proportion of secondary bacterial or fungal infection of each group.

The proportion of secondary bacterial or fungal infection of each group.

Time frame
From enrollment to the end of treatment on Day 28.
4

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.

Other outcomes

Sponsors and contacts

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