NCT04272710

Brief Summary

There are currently no clinical studies reporting clinical characteristics difference between the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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 25, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

February 12, 2020

Last Update Submit

March 13, 2020

Conditions

2019-nCoV

Outcome Measures

Primary Outcomes (3)

  • Occupancy rate in the intensive care unit (ICU)

    The percentage of patients admitted to the ICU at any time during the 28 days of onset COVID-19.

    up to 28 days

  • Mechanical Ventilation

    The number of patients requiring mechanical ventilation.

    up to 28 days

  • Death

    The number of patients who died of 2019-nCoV infection.

    up to 28 days

Secondary Outcomes (3)

  • All cause mortality

    up to 28 days

  • Time from onset of symptoms to main outcome and its components

    up to 28 days

  • Time to Clinical Recovery

    up to 28 days

Study Arms (2)

ACEI treatment

hypertension patients with ACEI treatment when suffered with novel coronavirus infection in China

Control

hypertension patients without ACEI treatment when suffered with novel coronavirus infection in China

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the hypertension patients with and without ACEI treatment when suffered with novel coronavirus infection in China

You may qualify if:

  • Adult aged \>=18years old;
  • Diagnosed with 2019-nCoV. Diagnostic criteria including: Laboratory (RT-PCR) confirmed 2019-nCoV infection; CT of the lung conformed to the manifestation of viral pneumonia.
  • Diagnosed with primary hypertension.
  • Criteria for severe or critical ill conditions: Respiratory rate \>=30/min; or Rest SPO2\<=93%; or PaO2/FiO2\<=300mmHg.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 12, 2020

First Posted

February 17, 2020

Study Start

January 25, 2020

Primary Completion

March 31, 2020

Study Completion

April 30, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations

CN(1)