CTRI Number |
CTRI/2021/05/033622 [Registered on: 14/05/2021] Trial Registered Prospectively |
Last Modified On: |
14/05/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Other |
Public Title of Study
|
Plasma therapy (IgG) in moderate to severe COVID-19 patients |
Scientific Title of Study
|
A Randomized, Open-label Parallel Group Study to Evaluate Efficacy and Safety of Intravenous Immunoglobulin (IVIG) in Hospitalized patients with COVID-19 |
Trial Acronym |
IVIG |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr M K Daga |
Designation |
Director – Professor |
Affiliation |
Maulana Azad Medical College |
Address |
129, B.L Taneja Block, Department of Medicine, Maulana Azad Medical College
Central DELHI 110002 India |
Phone |
9968604273 |
Fax |
|
Email |
drmraduldaga@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr M K Daga |
Designation |
Director - Professor |
Affiliation |
Maulana Azad Medical College |
Address |
129, B.L Taneja Block, Department of Medicine, Maulana Azad Medical College
Central DELHI 110002 India |
Phone |
9968604273 |
Fax |
|
Email |
drmraduldaga@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Govind Mawari |
Designation |
Scientist B |
Affiliation |
Maulana Azad Medical College |
Address |
129, B.L Taneja Block, Department of Medicine, Maulana Azad Medical College
Central DELHI 110002 India |
Phone |
9968829919 |
Fax |
|
Email |
sonumawari@gmail.com |
|
Source of Monetary or Material Support
|
Maulana Azad Medical College and Associated Hospitals |
|
Primary Sponsor
|
Name |
Lok Nayak Hospital |
Address |
Jawaharlal Nehru Marg, near Delhi Gate, LNJP Colony, New Delhi, Delhi 110002 |
Type of Sponsor |
Government medical college |
|
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 M K Daga |
Maulana Azad Medical College |
129, Department of Medicine, B.L Taneja Block, Maulana Azad Medical College associated L. N Hospital Central DELHI |
9968604273
drmraduldaga@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, MAMC associated Hospitals |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intravenous Immunoglobulin (IVIG)
|
400mg /kg b.w. per day for 5 days |
Comparator Agent |
not applicable |
not applicable |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Male or female subjects in between 18 years to 65 years
1. Moderate Illness: Adolescent or adult with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 ≤94% (range: 90-94%) on room air, Respiratory rate more or equal to 24 breaths per minutes. (As per MoHFW)
2. Severe Illness: Adolescent or adult with clinical signs of severe Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air. (As per MoHFW)
|
|
ExclusionCriteria |
Details |
Known hypersensitivity to immunoglobulin.
History or presence of any disorder that increases the safety risk of the patient as per investigator discretion.
History of DVT, PE, thromboembolic stroke or other thrombotic events.
Active participant in another research treatment study.
Pregnancy.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Clinical improvement measured by improvement in National Early Warning Score 2 (NEWS2) Score at the end of treatment |
3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Change in oxygen saturation by pulse oximetry. All-cause mortality till day 60
Mean Number of days of hospitalization.
Number of days of mechanical ventilation
Proportion of patient with fever at each visit
Time required to RT-PCR negative
Safety (Number of AEs, SAEs, Infusion reactions) (Additional endpoints requiring investigations CT Score, Severity of pneumonia can be added –will depend upon clinical set up. |
3 months |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
21/05/2021 |
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="3" 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 study will be conducted by the Lok Nayak Hospital, New Delhi. The study subjects will be enrolled from the population of moderate to severe COVID-19 positive cases requiring BiPAP support and who are willing to be a part of the study. For the study, a total of 60moderate to severe COVID-19 positive subjects would be recruitedwhich would be further divided into two treatment arms; the first treatment arm would have 30 moderate to severe COVID-19 positive subjects which will be treated with standard treatment + Intravenous Immunoglobulin (IVIG) drug at 400mg/kg/day for 5 days and the second treatment arm would have 30 moderate to severe COVID-19 positive subjects which will be treated with the standard treatment. Only the subjects (Male or Female) who are above the age of 18 would be included for the study. The criteria for the moderate and the severe illness in COVID-19 are as:-Moderate Illness: Adolescent or adult with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 ≤94% (range: 90-94%) on room air, Respiratory rate more or equal to 24 breaths per minutes; Severe Illness: Adolescent or adult with clinical signs of severe Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air. All the subjects will be excluded if they have any of the following: Known hypersensitivity to immunoglobulin, History or presence of any disorder that increases the safety risk of the patient as per investigator discretion, History of DVT, PE, thromboembolic stroke or other thrombotic events, Active participant in another research treatment study andPregnancy. The follow-ups will be done everyday till discharge and for day 30 and day 60 follow-up it can be telephonic. RT-PCR will be done at day 14 which will be repeated if negative. Day 0 follow-up will be considered as the baseline. Safety Assessment Labs: (Screening/ Day 0, Day 5, Day 30 EOS Visit i.e., day 60) Haematology, Biochemistry (LFT, KFT, D-dimer, CRP, LDH, Urinalysis, ABG, SpO2). Safety lab assessment needs to be done at discharge. If discharge is within 7 days of scheduled safety assessment, the scheduled assessment can be skipped. As per the investigator’s judgement Chest X ray, CT Scans (on day 30 and day 60) would be considered. For statistical analysis data will be entered in excel sheet and analyzed using SPSS-PC25 version. Data will be expressed in proportions and relationship to immune status will be determined with co- morbid conditions, age and gender by Chi-square test. ‘p’ less than 0.05 will be considered as statistically significant. A proper written informed consent will be obtained from all the study participants after explaining the study procedures along with benefits and risks of participation. Participation will be on voluntary basis. Privacy and confidentiality of data will be maintained. |