NCT05682573

Brief Summary

This study is a prospective cohort study aimed to clarify the continuous immune state changes of patients with COVID-19. Investigators include the patients admitted to the hospital within one week after the onset of COVID-19. 10ml of patients' blood was collected day 1, day 7, day 14 , and day 20 after the patients admitted to the hospital. The blood inflammatory factors, immune related molecules, and immune cells were detected to determine the changes of patients' immune status. The impact of immune status changes on prognosis and quality of life in later follow-up period was evaluated by various questionnaires and evaluation scales.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 12, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

January 7, 2023

Last Update Submit

January 10, 2023

Conditions

COVID-19ImmunityLife Quality

Outcome Measures

Primary Outcomes (3)

  • Changes in the concentration of inflammatory markers (IL-1β、IL-2、 IL-2R 、IL-4 、 IL-6 、 IL-8、 IL-10 、 interferon-gamma（IFN-γ）、tumour necrosis factor alpha(TNF-α) 、vascular endothelial growth factor（VEGF）, etc.) in peripheral blood.

    1, 7, 14, 20 days after the patient arrives at the hospital

  • Changes in the concentration of immunosuppression makers(HLA-DR, Programmed Cell Death Ligand 1 （PD-1）, T cell immunoglobulin and mucin domain 3（TIM-3）,etc.) in peripheral blood.

    1, 7, 14, 20 days after the patient arrives at the hospital

  • Changes in the number of immune cells(Th1/Th2 cell, Treg cell, Myeloid-derived suppressor cells,etc.) in peripheral blood.

    1, 7, 14, 20 days after the patient arrives at the hospital

Secondary Outcomes (3)

  • self-reported symptom

    2，6 months after the patient arrives at the hospital

  • health related quality of life (HRQoL) questionnaire,

    2，6 months after the patient arrives at the hospital

  • Hospital Anxiety and Depression Scale (HADS)

    2，6 months after the patient arrives at the hospital

Study Arms (1)

covid-19 Inpatients

Participant is diagnosed with symptomatic COVID-19 by a positive polymerase chain reaction(PCR) or rapid antigen detection for SARS-CoV-2 and with treatment in hospital

Diagnostic Test: hospitalized patient

Interventions

hospitalized patientDIAGNOSTIC_TEST

Collect the patient's whole blood for testing

covid-19 Inpatients

Eligibility Criteria

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

Participant is diagnosed with symptomatic COVID-19 by a positive PCR or rapid antigen detection for SARS-CoV-2 and with treatment in hospital

You may qualify if:

  • Patients diagnosed as novel coronavirus infection by PCR or antigen rapid detection for the first time
  • Patients hospitalized within one week after the occurrence of clinical symptoms related to novel coronavirus infection (fever, cough, shortness of breath or dyspnea, fatigue, headache, muscle or body pain, sore throat, nasal congestion or runny nose, chills, nausea, vomiting, diarrhea, mental state changes)
  • Age over 18, gender unlimited

You may not qualify if:

  • Patients with immunosuppression, including HIV infection, hematopoietic stem cell transplantation and high-dose immunosuppressant therapy
  • Patients with severe autoimmune diseases
  • Patients receiving chemotherapy or cancer treatment
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250112, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

10ml\*4 blood sample

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Central Study Contacts

yuguo Chen, Dr

CONTACT

+8618678812777chen919085@126.com

Study Design

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

Study Record Dates

First Submitted

January 7, 2023

First Posted

January 12, 2023

Study Start

January 5, 2023

Primary Completion

November 30, 2023

Study Completion

December 31, 2023

Last Updated

January 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)