COVID-19Phase 4ESPTCSCKDNCT05938140
Efficiency and Safety of Paxlovid for COVID-19 Patients With Severe Chronic Kidney Disease
A Phase 4 study testing Nirmatrelvir/ritonavir in people with COVID-19 and Renal Insufficiency, Chronic, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This is a prospective, single-center, open and self-controlled study.The purpose of this study is to evaluate the efficacy and safety of Paxlovid for the treatment of COVID-19 patients with severe chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Renal Insufficiency, Chronic
- What is being tested?
- Nirmatrelvir/ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 22 Jun 2023to 30 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Patients with chronic kidney disease above stage 4 (eGFR <30ml/min/1.73m2)
- with positive DNA test or antigen test for COVID-19
- Agree to participate in the study and sign the informed consent form voluntarily
Who cannot join
- Allergic to any component of nimatevir/ritonavir tablets.
- Drugs that are being or need to be taken that are prohibited to be combined with nimatevir tablets or ritonavir tablets as specified in the instructions (including, but not limited to: methidine, amiodarone, propafenone, quinidine, simvastatin, voriconazole, fusidic acid, rifabutine, rifampicin, colchicine, clozapine, quinoline) thiopine, cisapride, simvastatin, dixima, surazadine, fluoxam, oral midazolam and triazolam etc.)
- Renal transplantation failure is taking an immune agent that namatavir tablets/ritonavir tablets can not combine.
- Severe liver injury (Child-Pugh C) or acute liver failure.
- Critically ill patients requiring ventilator-assisted respiratory support.
- patients who cannot take the whole tablet.
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- HIV infection with a viral load greater than 400 copies/ml.
- Suspected or confirmed active systemic infections, other than coronavirus pneumonia, that may have an impact on the evaluation of the study.
- Uremia-related complications include acute heart failure, respiratory failure, severe chronic kidney disease, and cardiovascular disease.
- Patients who are pregnant or are planning a recent pregnancy.
- The researchers didn't consider the patients to be eligible for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Nan Bai, phD, 8610-66937166, bainan82@126.com
About this study
Official title: Efficiency and Safety of Paxlovid for the Treatment of COVID-19 Patients With Severe Chronic Kidney Disease
This is a prospective, single-center, open and self-controlled study.The purpose of this study is to evaluate the efficacy and safety of Paxlovid for the treatment of COVID-19 patients with severe chronic kidney disease.
Read the detailed description
Patients with chronic kidney disease (CKD) have a significantly increased risk of hospitalization or death due to severe COVID-19. A meta-analysis of 348 studies (382,407 COVID-19 and 1,139,979 patients with chronic kidney disease) showed that the incidence of COVID-19 in patients receiving maintenance dialysis was higher than that in CKD patients who did not need renal replacement therapy. The mortality of CKD patients in COVID-19 is higher than that of CKD patients without COVID-19. Another meta-analysis showed that COVID-19 infection was closely related to the mortality of CKD patients. The mortality rate of CKD patients infected with COVID-19 is 5.81 times higher than that of CKD patients not infected with COVID-19.
The severe/critical high-risk groups defined in the novel coronavirus Infection Diagnosis and Treatment Program formulated by the National Health and Wellness Commission include kidney disease and maintenance dialysis patients. It is clearly stated in the treatment plan that adult patients with mild or moderate severity and high risk factors should be treated with antiviral therapy within 5 days of onset.
Naimatevir tablets/ritonavir tablets (Paxlovid) are commonly used antiviral drugs at present, but it is not recommended for patients with severe renal insufficiency at present, mainly because the data of drug metabolism of Naimatevir/Ritonavir in this population are insufficient. Because the efficacy of Naimatevir/Ritonavir in patients with Covid-19 infection is clear, and the small sample of clinical research data of patients with severe renal insufficiency shows that it has a small safety risk, this study intends to carry out the safety and efficacy study of Naimatevir/Ritonavir in CKD5 patients, and at the same time, carry out the pharmacokinetic study to determine whether Naimatevir/Ritonavir can be used in the treatment of CKD5 patients.
- Conditions
- COVID-19, Renal Insufficiency, Chronic
- Being tested
- Nirmatrelvir/ritonavir
- Medical subject headings
- COVID-19, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nirmatrelvir/ritonavirDrug
Also called Paxlovid
Paxlovid is an oral drug for the treatment of COVID-19. It is suitable for adults with mild to moderate COVID-19 patients with high risk factors for progression to severe disease.
| Study group | Role | What they receive |
|---|---|---|
| Paxlovid group | Other | Patients will take Paxlovid.On the first day, Nematavir tablet 300mg/Ritonavir tablet 100mg orally once, then Nematavir tablet 150mg/ Ritonavir tablet 100mg orally once a day for 4 days. Dialysis patients must took the medication after dialysis. Receives: Drug: Nirmatrelvir/ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Security indexes
Adverse and serious adverse events were recorded
Measured: Start medication until 14 days
Secondary outcomes (5)
SARS-CoV-2 nucleic acid negative transformation time
SARS-CoV-2 nucleic acid first positive to negative time.
Measured: 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:
- shortness of breath, RR>30 times/minute:
- At rest, when inhaling air, the oxygen saturation is less than 93%;
- Partial arterial oxygen pressure (Pa02)/ oxygen concentration (Fi02)<300mmHg.
- 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:
- Respiratory failure occurs and mechanical ventilation is needed;
- Shock:
- Other organ failure requires ICU monitoring and treatment.
Measured: Start medication until 14 days
Overall mortality from SARS-CO-2 infection
The rate of patients died of Covid-19 infection.
Measured: 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.
Measured: 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.
Measured: Start medication until 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start22 Jun 2023
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zhang, Chinese PLA General Hospital
- Investigators
- Nan Bai, phD, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938140
- Sponsor's protocol ID
- ChinaPLAGH-2023ESP-CKD
- Acronym
- ESPTCSCKD
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety of Paxlovid for the Treatment of COVID-19 Patients With Severe Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05938140
- Acronym / sponsor ID
- ESPTCSCKD / ChinaPLAGH-2023ESP-CKD
- Conditions
- COVID-19, Renal Insufficiency, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, single-center, open and self-controlled study.The purpose of this study is to evaluate the efficacy and safety of Paxlovid for the treatment of COVID-19 patients with severe chronic kidney disease.
Detailed description
Patients with chronic kidney disease (CKD) have a significantly increased risk of hospitalization or death due to severe COVID-19. A meta-analysis of 348 studies (382,407 COVID-19 and 1,139,979 patients with chronic kidney disease) showed that the incidence of COVID-19 in patients receiving maintenance dialysis was higher than that in CKD patients who did not need renal replacement therapy. The mortality of CKD patients in COVID-19 is higher than that of CKD patients without COVID-19. Another meta-analysis showed that COVID-19 infection was closely related to the mortality of CKD patients. The mortality rate of CKD patients infected with COVID-19 is 5.81 times higher than that of CKD patients not infected with COVID-19.
The severe/critical high-risk groups defined in the novel coronavirus Infection Diagnosis and Treatment Program formulated by the National Health and Wellness Commission include kidney disease and maintenance dialysis patients. It is clearly stated in the treatment plan that adult patients with mild or moderate severity and high risk factors should be treated with antiviral therapy within 5 days of onset.
Naimatevir tablets/ritonavir tablets (Paxlovid) are commonly used antiviral drugs at present, but it is not recommended for patients with severe renal insufficiency at present, mainly because the data of drug metabolism of Naimatevir/Ritonavir in this population are insufficient. Because the efficacy of Naimatevir/Ritonavir in patients with Covid-19 infection is clear, and the small sample of clinical research data of patients with severe renal insufficiency shows that it has a small safety risk, this study intends to carry out the safety and efficacy study of Naimatevir/Ritonavir in CKD5 patients, and at the same time, carry out the pharmacokinetic study to determine whether Naimatevir/Ritonavir can be used in the treatment of CKD5 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paxlovid group | Other | Drug: Nirmatrelvir/ritonavirPatients will take Paxlovid.On the first day, Nematavir tablet 300mg/Ritonavir tablet 100mg orally once, then Nematavir tablet 150mg/ Ritonavir tablet 100mg orally once a day for 4 days. Dialysis patients must took the medication after dialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Patients with chronic kidney disease above stage 4 (eGFR <30ml/min/1.73m2)
- with positive DNA test or antigen test for COVID-19
- Agree to participate in the study and sign the informed consent form voluntarily
Key exclusion criteria (11 listed)
- Allergic to any component of nimatevir/ritonavir tablets.
- Drugs that are being or need to be taken that are prohibited to be combined with nimatevir tablets or ritonavir tablets as specified in the instructions (including, but not limited to: methidine, amiodarone, propafenone, quinidine, simvastatin, voriconazole, fusidic acid, rifabutine, rifampicin, colchicine, clozapine, quinoline) thiopine, cisapride, simvastatin, dixima, surazadine, fluoxam, oral midazolam and triazolam etc.)
- Renal transplantation failure is taking an immune agent that namatavir tablets/ritonavir tablets can not combine.
- Severe liver injury (Child-Pugh C) or acute liver failure.
- Critically ill patients requiring ventilator-assisted respiratory support.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nirmatrelvir/ritonavirAlso: PaxlovidPaxlovid is an oral drug for the treatment of COVID-19. It is suitable for adults with mild to moderate COVID-19 patients with high risk factors for progression to severe disease. | Drug | Paxlovid group |
Primary outcome
Security indexes
Time frame: Start medication until 14 days
Adverse and serious adverse events were recorded
5 secondary outcomes
SARS-CoV-2 nucleic acid negative transformation time
Time frame: Start medication until 14 days
The proportion of disease that progresses to severe or critical type
Time frame: Start medication until 14 days
Overall mortality from SARS-CO-2 infection
Time frame: Start medication until 14 days
Plotting the concentration-time curve of Paxlovid and its semi-logarithmic curve
Time frame: Start medication until 14 days
PK/PD scatter plots
Time frame: Start medication until 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nan Bai, phD study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nirmatrelvir/ritonavir in people with COVID-19 and Renal Insufficiency, Chronic, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, Doctor (8610-55499226, zhangl301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Security indexes (time frame: Start medication until 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.