NCT04328454

Brief Summary

As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

March 27, 2020

Last Update Submit

March 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to negative conversion of severe acute respiratory syndrome coronavirus 2

    The primary outcome is the time to negative conversion of coronavirus

    1 month

Secondary Outcomes (3)

  • Length of stay in hospital

    1 month

  • Survival

    1 month

  • Intubation

    1 month

Study Arms (1)

COVID-19 patients

Hospitalized patients with COVID-19

Other: retrospective analysis

Interventions

The investigators retrospectively analyzed the hospitalized patients with COVID-19

COVID-19 patients

Eligibility Criteria

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

Patients with COVID-19

You may qualify if:

  • Adult aged \>=18years old; Diagnosed with CONVID19. Diagnostic criteria including: Laboratory (RT-PCR) confirmed SARS-Cov-2 infection; CT of the lung conformed to the manifestation of viral pneumonia.

You may not qualify if:

  • Near-death state (expected survival time less than 24 hours); Malignant tumor; Pregnancy or puerperium women; Patients who refused to participant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai 10th People's Hospital

Shanghai, Shanghai Municipality, +86200072, China

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shanghai 10th People's Hospital

Study Record Dates

First Submitted

March 27, 2020

First Posted

March 31, 2020

Study Start

January 30, 2020

Primary Completion

April 2, 2020

Study Completion

April 15, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations