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NCT Number: NCT06610643

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combination therapy

Drug

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

Other names: remdesivir and Nirmatrelvir/Ritonavir

SoC

Drug

Standard of care

Primary outcomes

  1. The proportion of SARS-CoV-2 CT > 30 on Day 14

    Time frame: 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 outcomes

  1. The proportion of mortality or respiratory failure requiring intubation and mechanical ventilation.

    Time frame: 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.

  2. 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 patients developing anti-viral treatment emerging adverse events.

  3. 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 secondary bacterial or fungal infection of each group.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+886-2-2312-3456 ext. 263517

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Acronym: SARS-CoV-2

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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