NCT04422379

Brief Summary

COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study. All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 \& prospective data from approval till 30/6/2020), will be included

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
314

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 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

First Submitted

Initial submission to the registry

June 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 7, 2020

Last Update Submit

June 7, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • COVID-19 Positive Case

    To study the prevalence of liver live injury \& factors associated with among patients in-fected with SARS-CoV-2.

    4-8 weeks

  • COVID-19 Positive Case

    To study the prevalence of new liver injury and factors associated with it, among patient with underlying liver disease who develops COVID-19.

    4-8 weeks

Secondary Outcomes (2)

  • COVID-19 Positive Case

    4-8 weeks

  • COVID-19 Positive Case

    4-8 weeks

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population will include all the COVID 19 patients (male \& female) with minimum age 18 years old. And take 60% patient in Retrospective arm and 40% patient in prospective arm.

You may not qualify if:

  • Patients less that 18 years old with COVID-19
  • Pregnant ladies with COVD-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max Super Speciality Hospital, Saket (A Unit Of Devki Devi Foundation)

New Delhi, Dlelhi, 110017, India

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kaushal Madan, DM

    Max healthcare

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

June 7, 2020

First Posted

June 9, 2020

Study Start

June 7, 2020

Primary Completion

July 30, 2020

Study Completion

August 30, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations