Back to resultsPaxlovid in the Treatment of COVID-19 Patients With Uremia
Primary Purpose
COVID-19, Uremia
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Paxlovid
standard-of-care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
standard-of-care
standard-of-care plus Paxlovid
Arm Description
Standard-of-care of COVID-19 includes oxygen inhalation, antibiotics, traditional medicine, etc.
standard-of-care of COVID-19 plus Paxlovid
Outcomes
Primary Outcome Measures
time of negative conversion of SARS-CoV-2 nucleic acid
Time from first positive to negative of SARS-CoV-2 nucleic acid
Proportion of ICU transfer or disease progression to severe or critical illness
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05386433
Brief Title
Paxlovid in the Treatment of COVID-19 Patients With Uremia
Official Title
The Effect of Paxlovid in the Treatment of COVID-19 Patients With Uremia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Uremia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard-of-care
Arm Type
Placebo Comparator
Arm Description
Standard-of-care of COVID-19 includes oxygen inhalation, antibiotics, traditional medicine, etc.
Arm Title
standard-of-care plus Paxlovid
Arm Type
Experimental
Arm Description
standard-of-care of COVID-19 plus Paxlovid
Intervention Type
Drug
Intervention Name(s)
Paxlovid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
standard-of-care
Intervention Description
standard-of-care of COVID-19
Primary Outcome Measure Information:
Title
time of negative conversion of SARS-CoV-2 nucleic acid
Description
Time from first positive to negative of SARS-CoV-2 nucleic acid
Time Frame
up to 60 days
Title
Proportion of ICU transfer or disease progression to severe or critical illness
Time Frame
up to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Paxlovid in the Treatment of COVID-19 Patients With Uremia
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