Paxlovid in the Treatment of COVID-19 Patients With Uremia

Shanghai Jiao Tong University

Status and phase: Unknown; Early Phase 1

Conditions: COVID-19; Uremia

Treatments: Drug: standard-of-care; Drug: Paxlovid

Study type: Interventional

Funder types: Other

Identifiers

NCT05386433

PaxlovidUremia

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

standard-of-care

Placebo Comparator group

Description:

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

Treatment:

Drug: standard-of-care

standard-of-care plus Paxlovid

Experimental group

Description:

standard-of-care of COVID-19 plus Paxlovid

Treatment:

Drug: Paxlovid

Drug: standard-of-care