Paxlovid in the Treatment of COVID-19 Patients With Uremia

Early Phase 1UnknownNCT05386433

Ruijin Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19 Uremia

Interventions

PaxlovidDRUG

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-careDRUG

standard-of-care of COVID-19

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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.). Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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

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

Time frame: up to 60 days

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

Time frame: up to 60 days

Data from ClinicalTrials.gov

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