Paxlovid in the Treatment of COVID-19 Patients With Uremia

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05386433
• Other study ID #: PaxlovidUremia
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 2022
• Est. completion date: August 2022

Study information

• Verified date: May 2022
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Uremia

Intervention

Drug:
• Paxlovid
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
standard-of-care of COVID-19

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of ICU transfer or disease progression to severe or critical illness		up to 60 days