Cytopenias in Hospitalized Patients of Corona Virus Infec... | NCT05258812

Studies
Cytopenias in Hospitalized Patients of Corona Virus Infection(COVID-19) During First and Other Waves

NCT05258812

Sponsor

Fatima Memorial Hospital

Status

Completed

Last Update Posted

Feb 28, 2022Actual

Enrollment

202Actual

Phase

Not provided

Conditions

Corona Virus Infection

Interventions

Not provided

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2020Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Feb 8, 2022

First Submission Date that Met QC Criteria

Feb 25, 2022

First Posted Date

Feb 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2022

Last Update Posted Date

Feb 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Demographic, Clinical and laboratory data as well as outcome of total 202 COVID-19 patients who were Polymerase Chain Reaction (PCR) positive and admitted in Fatima memorial Hospital, Lahore, Pakistan, was collected during first and other waves. Data of First wave is from May 2020 to July 2020, second wave from early November to Mid December 2020 and third wave from Mid march to June 2021. Investigator analyzed the data on basis of Systemic immune inflammatory index (SII) as well hematological parameters of First Wave were compared to other waves of COVID-19.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

202Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cytopenias in Hospitalized Patients of COVID-19 During First and Other waves	extent of cytopenias is being measured in COVID-19 hospitalized patients.	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COVID-19 Positive Hospitalized patients
All genders

Exclusion Criteria:

Patients with Known hematological disorders
Patients with known chronic Liver Disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

95 Years

Standard Ages

ChildAdultOlder Adult

Study Population

COVID-19 Positive Hospitalized patients, of all genders and all age group.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fatima memorial Hospital		Lahore	Punjab Province	54000	Pakistan

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 15, 2022	Feb 11, 2022	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D018352	Coronavirus Infections
D000086382	COVID-19
D000095542	Cytopenia
D013921	Thrombocytopenia
D000740	Anemia
D007970	Leukopenia

Ancestor Terms

ID	Term
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided