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

NCT06610643 | Not Yet Recruiting

• 1 other identifier: 202405064MIND
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; SARS-CoV-2; Immunocompromised

Keywords

Extended RDV infusion combination therapy for SARS-CoV-2 infection in immunocompromised patients

Outcome Measures

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.

  From enrollment to the end of treatment on Day 14.

Secondary Outcomes (4)

• 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 patients developing anti-viral treatment emerging adverse events.

  From enrollment to the end of treatment on Day 28.

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

  From enrollment to the end of treatment on Day 28.

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

  From enrollment to the end of treatment on Day 28.

Study Arms (2)

combination therapy

EXPERIMENTAL

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

Drug: combination therapy; Drug: SOC

SOC

ACTIVE COMPARATOR

standard of care

Drug: SOC

Interventions

combination therapy DRUG

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

Also known as: remdesivir and Nirmatrelvir/Ritonavir

combination therapy

SOC DRUG

Standard of care

SOC; combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

Location

MeSH Terms

Conditions

COVID-19

Interventions

Combined Modality Therapy; remdesivir; nirmatrelvir; Ritonavir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor,

Study Record Dates

• First Submitted: September 22, 2024
• First Posted: September 24, 2024
• Study Start: September 21, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

TW (1)