| CTRI Number |
CTRI/2021/01/030630 [Registered on: 20/01/2021] Trial Registered Prospectively |
| Last Modified On: |
19/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to identify SARS-CoV-2 in Red Blood Cells in infected patients. |
|
Scientific Title of Study
|
A study to identify SARS-CoV-2 in erythrocytes of patients suffering from COVID-19 at an Apex tertiary care institute in Andhra Pradesh, South India. |
| Trial Acronym |
19CoVRBC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr I S Chaitanya Kumar |
| Designation |
Associate Professor and I/C Head |
| Affiliation |
Faculty at AIIMS, Mangalagiri |
| Address |
Department of Transfusion Medicine and hemotherapy, All India Institute of Medical Sciences, Mangalagiri, Guntur District.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9440106689 |
| Fax |
|
| Email |
ischaitanyakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I S Chaitanya Kumar |
| Designation |
Associate Professor and I/C Head |
| Affiliation |
Faculty at AIIMS, Mangalagiri |
| Address |
Department of Transfusion Medicine and Hemotherapy, All India Institute of Medical Sciences, Mangalagiri, Guntur District
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9440106689 |
| Fax |
|
| Email |
ischaitanyakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I S Chaitanya Kumar |
| Designation |
Associate Professor and I/C Head |
| Affiliation |
Faculty at AIIMS, Mangalagiri |
| Address |
Department of Transfusion Medicine and Hemotherapy, All India Institute of Medical Sciences, Mangalagiri, Guntur District
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9440106689 |
| Fax |
|
| Email |
ischaitanyakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self & All India Institute of Medical Sciences, Mangalagiri |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences, Mangalagiri |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr I S Chaitanya Kumar |
All India Institute of Medical Sciences |
Room No.35, Department of Transfusion Medicine, AIIMS, Mangalagiri
Guntur
ANDHRA PRADESH |
9440106689
ischaitanyakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS MANGALAGIRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COVID-19 POSITIVE |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
COVID-19 Positive by RT-PCR |
|
| ExclusionCriteria |
| Details |
1.Negative for COVID-19 illness
2.Not willing to participate in the study
3.Age <18 years or >55 years
4.Prisoners
5.Pregnant women
6.Severely ill patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Detection of COVID-19 RNA in RBC/Blood samples during active infection |
immediately at enrolment considered Day1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DETECTION OF COVID-19 RNA IN RBC/BLOOD SAMPLES PLASMA OR LEUKOREDUCTION |
AFTER CENTRIFUGATION
AFTER 3RD WASH
AFTER 6TH WASH
AFTER LEUKOREDUCTION |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The novel corona virus which started as an epidemic in Wuhan, China has become a pandemic affecting most countries in the world and infected a total of 53,04,772 people, with growing incidence rates of 1,00,264 patients every day, has caused deaths of 3,42,029 people across the globe as per World Health Organization (WHO). India, a developing country with the second largest population has reported a total of 1,38,845 people being infected and a total of 4,021 deaths due to novel corona virus pneumonia (COVID-19) as of 25th May 2020. There are studies that suggest that the novel COVID-19 disease can also attack 1-beta chain of haemoglobin and captures the porphyrin to inhibit human heme metabolism. In the present study, we would like to know whether SARS-CoV-2 has the capability to infect Erythrocytes. The effect of various modification on COVID-19 in blood will also be checked. |