Paxlovid in the Treatment of COVID-19 Patients With Uremia

Early Phase 1

• Conditions: COVID-19; Uremia
• Interventions: Drug: standard-of-care; Drug: Paxlovid

• Registration Number: NCT05386433
• Lead Sponsor: Ruijin Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-20
• Last Update Submitted: 2022-05-20
• Study First Posted: 2022-05-23
• Last Update Posted: 2022-05-23
• Study Start: 2022-06
• Primary Completion: 2022-07
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard-of-care	standard-of-care	Standard-of-care of COVID-19 includes oxygen inhalation, antibiotics, traditional medicine, etc.
standard-of-care plus Paxlovid	standard-of-care	standard-of-care of COVID-19 plus Paxlovid
standard-of-care plus Paxlovid	Paxlovid	standard-of-care of COVID-19 plus Paxlovid

Primary Outcome Measures

Name	Time	Method
time of negative conversion of SARS-CoV-2 nucleic acid	up to 60 days	Time from first positive to negative of SARS-CoV-2 nucleic acid
Proportion of ICU transfer or disease progression to severe or critical illness	up to 60 days