COVID-19NCT05559138
Analysis of Clinical Characteristics of Hemodialysis Patients With Omicron Infection
An observational study of COVID-19, run by RenJi Hospital at 1 site in China.
Trial summary
By collecting the clinical data of hemodialysis patients with Omicron infection in RenJi Hospital from April 7, 2022 to June 10, 2022, the clinical characteristics of this population were analyzed. And to analyze the risk factors of different clinical outcomes according to the clinical outcome of this population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Aug 2022
- Phase
- Observational
- 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
Study population: patients with omicron infection
Who may be able to join
- Hemodialysis patients due to chronic kidney disease stage 5 with omicron infection
Who cannot join
- Patients on hemodialysis due to acute kidney injury
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality
About this study
By collecting the clinical data of hemodialysis patients with Omicron infection in RenJi Hospital from April 7, 2022 to June 10, 2022, the clinical characteristics of this population were analyzed. And to analyze the risk factors of different clinical outcomes according to the clinical outcome of this population.
Read the detailed description
This study was a single-center, retrospective, observational study. The research subjects were hemodialysis patients admitted to the Hemodialysis Center of Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine because of omicron infection during the Omicron epidemic period from April 7, 2022 to June 10, 2022. 65 cases were included in the study after excluding those patients who underwent hemodialysis due to acute kidney injury. And they were compared with 195 non-dialysis patients admitted to the hospital in the same period,who were randomly selected, according to the ratio of 1:3.
- Conditions
- COVID-19
- Being tested
- no intervention
- Keywords
- hemodialysis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| hemodialysis patients with omicron infection | hemodialysis patients with omicron infection Receives: Other: no intervention | |
| non-hemodialysis patients with omicron infection | non-hemodialysis patients with omicron infection Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral elimination
both negative for ORF1ab and N genes (Ct value ≥35 by real-time PCR) in two consecutive days.
Measured: 2022-4-7 to 2022-6-10
Secondary outcomes (1)
cardiovascular events
including acute left heart failure, new symptomatic arrhythmias requiring drug control, acute coronary syndrome
Measured: 2022-4-7 to 2022-6-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Jul 2022
- Primary completion31 Jul 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by RenJi 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiayue Lu, Study director, Renji Hospital affiliation to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559138
- Sponsor's protocol ID
- IIT-2022-0120
- Status last verified
- Jun 2022
- First submitted
- 26 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076De Meester J, De Bacquer D, Naesens M, Meijers B, Couttenye MM, De Vriese AS; NBVN Kidney Registry Group. Incidence, Characteristics, and Outcome of COVID-19 in Adults on Kidney Replacement Therapy: A Regionwide Registry Study. J Am Soc Nephrol. 2021 Feb;32(2):385-396. doi: 10.1681/ASN.2020060875. Epub 2020 Nov 5.
PubMed 33154174Shuai H, Chan JF, Hu B, Chai Y, Yuen TT, Yin F, Huang X, Yoon C, Hu JC, Liu H, Shi J, Liu Y, Zhu T, Zhang J, Hou Y, Wang Y, Lu L, Cai JP, Zhang AJ, Zhou J, Yuan S, Brindley MA, Zhang BZ, Huang JD, To KK, Yuen KY, Chu H. Attenuated replication and pathogenicity of SARS-CoV-2 B.1.1.529 Omicron. Nature. 2022 Mar;603(7902):693-699. doi: 10.1038/s41586-022-04442-5. Epub 2022 Jan 21.
PubMed 35062016Halfmann PJ, Iida S, Iwatsuki-Horimoto K, Maemura T, Kiso M, Scheaffer SM, Darling TL, Joshi A, Loeber S, Singh G, Foster SL, Ying B, Case JB, Chong Z, Whitener B, Moliva J, Floyd K, Ujie M, Nakajima N, Ito M, Wright R, Uraki R, Warang P, Gagne M, Li R, Sakai-Tagawa Y, Liu Y, Larson D, Osorio JE, Hernandez-Ortiz JP, Henry AR, Ciuoderis K, Florek KR, Patel M, Odle A, Wong LR, Bateman AC, Wang Z, Edara VV, Chong Z, Franks J, Jeevan T, Fabrizio T, DeBeauchamp J, Kercher L, Seiler P, Gonzalez-Reiche AS, Sordillo EM, Chang LA, van Bakel H, Simon V; Consortium Mount Sinai Pathogen Surveillance (PSP) study group; Douek DC, Sullivan NJ, Thackray LB, Ueki H, Yamayoshi S, Imai M, Perlman S, Webby RJ, Seder RA, Suthar MS, Garcia-Sastre A, Schotsaert M, Suzuki T, Boon ACM, Diamond MS, Kawaoka Y. SARS-CoV-2 Omicron virus causes attenuated disease in mice and hamsters. Nature. 2022 Mar;603(7902):687-692. doi: 10.1038/s41586-022-04441-6. Epub 2022 Jan 21.
PubMed 35062015Lewnard JA, Hong VX, Patel MM, Kahn R, Lipsitch M, Tartof SY. Clinical outcomes associated with SARS-CoV-2 Omicron (B.1.1.529) variant and BA.1/BA.1.1 or BA.2 subvariant infection in Southern California. Nat Med. 2022 Sep;28(9):1933-1943. doi: 10.1038/s41591-022-01887-z. Epub 2022 Jun 8.
PubMed 35675841
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Clinical Characteristics of Hemodialysis Patients With Omicron Infection
- ClinicalTrials.gov ID
- NCT05559138
- Acronym / sponsor ID
- IIT-2022-0120
- Conditions
- COVID-19
- Keywords
- hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 29 Sep 2022 (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.
By collecting the clinical data of hemodialysis patients with Omicron infection in RenJi Hospital from April 7, 2022 to June 10, 2022, the clinical characteristics of this population were analyzed. And to analyze the risk factors of different clinical outcomes according to the clinical outcome of this population.
Detailed description
This study was a single-center, retrospective, observational study. The research subjects were hemodialysis patients admitted to the Hemodialysis Center of Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine because of omicron infection during the Omicron epidemic period from April 7, 2022 to June 10, 2022. 65 cases were included in the study after excluding those patients who underwent hemodialysis due to acute kidney injury. And they were compared with 195 non-dialysis patients admitted to the hospital in the same period,who were randomly selected, according to the ratio of 1:3.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemodialysis patients with omicron infection | – | Other: no interventionhemodialysis patients with omicron infection |
| non-hemodialysis patients with omicron infection | – | Other: no interventionnon-hemodialysis patients with omicron infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with omicron infection
Key inclusion criteria (1 listed)
- Hemodialysis patients due to chronic kidney disease stage 5 with omicron infection
Key exclusion criteria (1 listed)
- Patients on hemodialysis due to acute kidney injury
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 |
|---|---|---|
| no interventionno intervention | Other | hemodialysis patients with omicron infection, non-hemodialysis patients with omicron infection |
Primary outcome
Viral elimination
Time frame: 2022-4-7 to 2022-6-10
both negative for ORF1ab and N genes (Ct value ≥35 by real-time PCR) in two consecutive days.
1 secondary outcome
cardiovascular events
Time frame: 2022-4-7 to 2022-6-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Results publication: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Results publication: PubMed 33154174De Meester J, De Bacquer D, Naesens M, Meijers B, Couttenye MM, De Vriese AS; NBVN Kidney Registry Group. Incidence, Characteristics, and Outcome of COVID-19 in Adults on Kidney Replacement Therapy: A Regionwide Registry Study. J Am Soc Nephrol. 2021 Feb;32(2):385-396. doi: 10.1681/ASN.2020060875. Epub 2020 Nov 5.
- Results publication: PubMed 35062016Shuai H, Chan JF, Hu B, Chai Y, Yuen TT, Yin F, Huang X, Yoon C, Hu JC, Liu H, Shi J, Liu Y, Zhu T, Zhang J, Hou Y, Wang Y, Lu L, Cai JP, Zhang AJ, Zhou J, Yuan S, Brindley MA, Zhang BZ, Huang JD, To KK, Yuen KY, Chu H. Attenuated replication and pathogenicity of SARS-CoV-2 B.1.1.529 Omicron. Nature. 2022 Mar;603(7902):693-699. doi: 10.1038/s41586-022-04442-5. Epub 2022 Jan 21.
- Results publication: PubMed 35062015Halfmann PJ, Iida S, Iwatsuki-Horimoto K, Maemura T, Kiso M, Scheaffer SM, Darling TL, Joshi A, Loeber S, Singh G, Foster SL, Ying B, Case JB, Chong Z, Whitener B, Moliva J, Floyd K, Ujie M, Nakajima N, Ito M, Wright R, Uraki R, Warang P, Gagne M, Li R, Sakai-Tagawa Y, Liu Y, Larson D, Osorio JE, Hernandez-Ortiz JP, Henry AR, Ciuoderis K, Florek KR, Patel M, Odle A, Wong LR, Bateman AC, Wang Z, Edara VV, Chong Z, Franks J, Jeevan T, Fabrizio T, DeBeauchamp J, Kercher L, Seiler P, Gonzalez-Reiche AS, Sordillo EM, Chang LA, van Bakel H, Simon V; Consortium Mount Sinai Pathogen Surveillance (PSP) study group; Douek DC, Sullivan NJ, Thackray LB, Ueki H, Yamayoshi S, Imai M, Perlman S, Webby RJ, Seder RA, Suthar MS, Garcia-Sastre A, Schotsaert M, Suzuki T, Boon ACM, Diamond MS, Kawaoka Y. SARS-CoV-2 Omicron virus causes attenuated disease in mice and hamsters. Nature. 2022 Mar;603(7902):687-692. doi: 10.1038/s41586-022-04441-6. Epub 2022 Jan 21.
- Results publication: PubMed 35675841Lewnard JA, Hong VX, Patel MM, Kahn R, Lipsitch M, Tartof SY. Clinical outcomes associated with SARS-CoV-2 Omicron (B.1.1.529) variant and BA.1/BA.1.1 or BA.2 subvariant infection in Southern California. Nat Med. 2022 Sep;28(9):1933-1943. doi: 10.1038/s41591-022-01887-z. Epub 2022 Jun 8.
- Individual participant dataSharing planned: Undecided
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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.
Jiayue Lu study director
Renji Hospital affiliation to Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by RenJi 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral elimination (time frame: 2022-4-7 to 2022-6-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05559138, which also lists 5 linked publications.
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 29 Sep 2022.