Safety and Clinical and Virologic Outcomes in CKD Patients Treated With Nirmatrelvir-ritonavir

NCT05624840 | Completed FDA Drug

• 1 other identifier: CRE-2022.361
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Nirmatrelvir-ritonavir is approved for coronavirus disease 2019 (COVID-19) but not initially recommended in patients with severe renal impairment. Increasing observational data have shown the feasibility of dose-adjusted nirmatrelvir-ritonavir administration in patients with estimated glomerular filtration rate lower than 30 ml/min/1.73 m\^2. The study is planned to assess the safety, clinical and virologic outcomes of early oral nirmatrevir-ritonavir treatment of COVID-19 in patients with stage 4 and 5 chronic kidney disease.

Conditions

COVID-19; Chronic Kidney Disease stage4; Chronc Kidney Disease Stage 5

Outcome Measures

Primary Outcomes (1)

• adverse event

  Adverse events during or after treatment with nirmatrelvir-ritonavir (starting on or before day 30), serious adverse events and adverse events leading to discontinuation of nirmatrelvir-ritonavir

  30 days

Secondary Outcomes (5)

• RAT

  30 days

• Rebound

  30 days

• WHO Clinical Progression Scale CPS

  30 days

• Symptoms

  30 days

• Symptomatic rebound

  30 days

Interventions

Nirmatrelvir/ritonavir DRUG

Nirmatrelvir-ritonavir (Paxlovid)

Also known as: Paxlovid

Eligibility Criteria

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

Study Population

This is a single centre study of 100 adult patients treated with nirmatrelvir-ritonavir for early COVID-19 disease in the omicron era.

You may qualify if:

• Aged 18 and above.
• COVID-19 infection and symptom onset no more than 5 days, with or without prior vaccination.
• WHO CPS 1-4
• Indicated for nirmatrelvir-ritonavir treatment

You may not qualify if:

• Patients cannot swallow capsules or adhere to protocol.
• Severe COVID-19 disease, including patients who require oxygen supplement therapy
• Significant hypersensitivity to nirmatrelvir, ritonavir, or any component of the formulation
• Patients require co-administration of drugs that are highly dependent on CYP3A4 for clearance and cannot be omitted during the treatment period

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Shatin, New Territories, SAR, Hong Kong

Location

Related Publications (1)

• Chan GCK, Lui GCY, Wong CNS, Yip SST, Li TCM, Cheung CSK, Sze RKH, Szeto CC, Chow KM. Safety Profile and Clinical and Virological Outcomes of Nirmatrelvir-Ritonavir Treatment in Patients With Advanced Chronic Kidney Disease and Coronavirus Disease 2019. Clin Infect Dis. 2023 Nov 17;77(10):1406-1412. doi: 10.1093/cid/ciad371.

  PMID: 37531093 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

nirmatrelvir and ritonavir drug combination

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 22, 2022
• Study Start: November 7, 2022
• Primary Completion: January 31, 2023
• Study Completion: February 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)