Paxlovid in the Treatment of COVID-19 Patients With Uremia

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Paxlovid in the Treatment of COVID-19 Patients With Uremia

Conditions
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COVID-19, Uremia

Intervention / Treatment
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* Drug: Paxlovid
* Drug: standard-of-care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: standard-of-care<br>Standard-of-care of COVID-19 includes oxygen inhalation, antibiotics, traditional medicine, etc. | Drug: standard-of-care<br>* standard-of-care of COVID-19<br>|
| Experimental: standard-of-care plus Paxlovid<br>standard-of-care of COVID-19 plus Paxlovid | Drug: Paxlovid<br>* 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.<br>Drug: standard-of-care<br>* standard-of-care of COVID-19<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |