NCT05559138

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
Last Updated

September 29, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

September 26, 2022

Last Update Submit

September 26, 2022

Conditions

COVID-19

Keywords

hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Viral elimination

    both negative for ORF1ab and N genes (Ct value ≥35 by real-time PCR) in two consecutive days.

    2022-4-7 to 2022-6-10

Secondary Outcomes (1)

  • cardiovascular events

    2022-4-7 to 2022-6-10

Study Arms (2)

hemodialysis patients with omicron infection

hemodialysis patients with omicron infection

Other: no intervention

non-hemodialysis patients with omicron infection

non-hemodialysis patients with omicron infection

Other: no intervention

Interventions

no interventionOTHER

no intervention

hemodialysis patients with omicron infectionnon-hemodialysis patients with omicron infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with omicron infection

You may qualify if:

  • Hemodialysis patients due to chronic kidney disease stage 5 with omicron infection

You may not qualify if:

  • Patients on hemodialysis due to acute kidney injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Location

Related Publications (5)

  • 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.

    PMID: 32171076RESULT

  • De 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.

    PMID: 33154174RESULT

  • Shuai 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.

    PMID: 35062016RESULT

  • Halfmann 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.

    PMID: 35062015RESULT

  • Lewnard 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.

    PMID: 35675841RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jiayue Lu

    Renji Hospital affiliation to Shanghai Jiao Tong University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2022

First Posted

September 29, 2022

Study Start

July 1, 2022

Primary Completion

July 31, 2022

Study Completion

August 1, 2022

Last Updated

September 29, 2022

Record last verified: 2022-06

Locations

CN(1)