Paxlovid in the Treatment of COVID-19 Patients With Uremia

NCT05386433 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: PaxlovidUremia
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-center, open-label, randomized controlled clinical study to evaluate the effect of Paxlovid on the virus-negative time and disease progression in uremic patients infected with SARS-CoV-2 (omicron variants). This study will enroll maintenance hemodialysis patients infected with SARS-CoV-2 (omicron variants). After signing the informed consent form, the qualified subjects will be randomly stratified 1:1 to standard-of-care (SOC) or SOC plus Paxlovid for five days.

Conditions

COVID-19; Uremia

Outcome Measures

Primary Outcomes (2)

• time of negative conversion of SARS-CoV-2 nucleic acid

  Time from first positive to negative of SARS-CoV-2 nucleic acid

  up to 60 days

• Proportion of ICU transfer or disease progression to severe or critical illness

  up to 60 days

Study Arms (2)

standard-of-care

PLACEBO COMPARATOR

Standard-of-care of COVID-19 includes oxygen inhalation, antibiotics, traditional medicine, etc.

Drug: standard-of-care

standard-of-care plus Paxlovid

EXPERIMENTAL

standard-of-care of COVID-19 plus Paxlovid

Drug: Paxlovid; Drug: standard-of-care

Interventions

Paxlovid DRUG

Paxlovid contains two medicines: nirmatrelvir and ritonavir. Nirmatrelvir \[PF-07321332\] is a SARS-CoV-2 main protease (Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor) that works by inhibiting viral replication in the early stages of the disease to prevent progression to severe COVID-19. Ritonavir is co-administered with nirmatrelvir to help slow its metabolism in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

standard-of-care plus Paxlovid

standard-of-care DRUG

standard-of-care of COVID-19

standard-of-care; standard-of-care plus Paxlovid

Eligibility Criteria

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

You may qualify if:

• Sign informed consent. Age ≥ 18 years old. COVID-19 (nucleic acid test positive) was diagnosed before randomization. At least 1 symptom or sign of COVID-19 at the time of being enrolled into the study(symptoms and signs related to COVID-19 including cough, expectoration, dyspnea, fever, chills, fatigue, muscle soreness, diarrhea, headache, sore throat, stuffy nose, runny nose, etc.).

You may not qualify if:

• History of active liver disease, including chronic or active hepatitis B or C, primary biliary cirrhosis, Child-Pugh B or C, or acute liver failure.
• HIV infection and the viral load is greater than 400 copies/ml. Suspected or confirmed active systemic infections that may have an impact on the study evaluation except for COVID-19.
• Acute heart failure, respiratory failure, severe chronic kidney disease, and cardiovascular disease caused by uremia-related complications.
• Allergic to any ingredients of Paxlovid.

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

COVID-19; Uremia

Interventions

nirmatrelvir and ritonavir drug combination; Standard of Care

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; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 23, 2022
• Study Start: June 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share