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Clinical Trial Details

Trial ID: L0677
Source ID: NCT05938140
Associated Drug: Nirmatrelvir/Ritonavir
Title: Efficiency and Safety of Paxlovid for COVID-19 Patients With Severe Chronic Kidney Disease
Acronym: ESPTCSCKD
Status: RECRUITING
Study Results: NO
Results:
Conditions: COVID-19|Renal Insufficiency, Chronic
Interventions: DRUG: Nirmatrelvir/ritonavir
Outcome Measures: Primary: Security indexes, Adverse and serious adverse events were recorded, Start medication until 14 days | Secondary: SARS-CoV-2 nucleic acid negative transformation time, SARS-CoV-2 nucleic acid first positive to negative time., Start medication until 14 days|The proportion of disease that progresses to severe or critical type, Severe type refer to any of the following and cannot be explained by other reasons other than Covid-19 infection: 1. shortness of breath, RR\>30 times/minute: 2. At rest, when inhaling air, the oxygen saturation is less than 93%; 3. Partial arterial oxygen pressure (Pa02)/ oxygen concentration (Fi02)\<300mmHg. 4. The clinical symptoms are getting worse, and the lung imaging shows that the lesion has obviously progressed more than 50% within 24 \~48 hours. Critical type refer to those who meet one of the following conditions: 1. Respiratory failure occurs and mechanical ventilation is needed; 2. Shock: 3. Other organ failure requires ICU monitoring and treatment., Start medication until 14 days|Overall mortality from SARS-CO-2 infection, The rate of patients died of Covid-19 infection., Start medication until 14 days|Plotting the concentration-time curve of Paxlovid and its semi-logarithmic curve, The concentration-time data of Paxlovid from D1 to D5 were described in a chart, and the dose-time curve and its semi-logarithmic curve were drawn., Start medication until 14 days|PK/PD scatter plots, PK/PD scatter plots were established with Paxlovid's plasma concentration as horizontal coordinate and nucleic acid load as vertical coordinate., Start medication until 14 days
Sponsor/Collaborators: Sponsor: Chinese PLA General Hospital
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-06-22
Completion Date: 2025-05-30
Results First Posted:
Last Update Posted: 2023-07-10
Locations: Chinese PLA General Hospital, Beijing, Beijing, 100853, China
URL: https://clinicaltrials.gov/show/NCT05938140