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CTRI Number  CTRI/2021/10/037591 [Registered on: 27/10/2021] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Other 
Public Title of Study   Use of Hemopurifier Device For The Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans. 
Scientific Title of Study   Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans with Hemopurifier Device 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vijay Kher 
Designation  Chairman  
Affiliation  Medanta The Medicity 
Address  Nephrology Medanta Kidney and Urology Institute Medanta The Medicity Sector 38 Gurugram

Gurgaon
HARYANA
122001
India 
Phone  01244141414  
Fax  01244834111  
Email  vijay.kher@medanta.org  
 
Details of Contact Person
Scientific Query  
Name  Vijay Kher 
Designation  Chairman  
Affiliation  Medanta The Medicity 
Address  Nephrology Medanta Kidney and Urology Institute Medanta The Medicity Sector 38 Gurugram

Gurgaon
HARYANA
122001
India 
Phone  01244141414  
Fax  01244834111  
Email  vijay.kher@medanta.org  
 
Details of Contact Person
Public Query  
Name  Sandeep Malik 
Designation  Founder and CEO 
Affiliation  Qualtran LLC 
Address  Qualtran LLC 8-401 Fresco Nirwana Country South City 2

Gurgaon
HARYANA
122018
India 
Phone  09654515015  
Fax    
Email  sandeepmalik2436@gmail.com  
 
Source of Monetary or Material Support  
Aethlon Medical Inc 9635 Granite Ridge Drive Suite 100 San Diego CA 92123 
 
Primary Sponsor  
Name  Aethlon Medical Inc 
Address  9635 Granite Ridge Drive Suite 100 San Diego CA 92123  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vijay Kher  Medanta The Medicity  Department of Nephrology Medanta Kidney and Urology Institute 12 Floor Medanta The Medicity Sector 38 Gurugram
Gurgaon
HARYANA 		 01244141414
01244834111
vijay.kher@medanta.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC, Maulana Azad Medical College  Submittted/Under Review 
Medanta Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Hemopurifier Device   Four hour treatment once daily for up to four days  
Comparator Agent  Standard Care  According to Investigator discretions 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Laboratory confirmed diagnosis of COVID-19 infection with any of the following disease characteristics
1A Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS)
1B Severe disease, defined as one of the following dyspnea, respiratory frequency more than or equal to 30/min
blood oxygen saturation less than or equal to 93 percentage partial pressure of arterial oxygen to fraction of inspired oxygen ratio of more than 300 and or lung infiltrates more than 50 percentage within 24 to 48 hours
1C Life-threatening disease, defined as one of the following respiratory failure septic shock and or multiple organ dysfunction or failure
2 Admission to the ICU or area of the hospital repurposed to function as an ICU for surge capacity management
3 Informed consent from the patient or legal representative
4. Age more than 18 years
 
 
ExclusionCriteria 
Details  1 Stroke known or suspected within the last 3 months
2 Severe congestive heart failure NYHA III and IV classes
3 Acute an international normalized ratio INR of greater than 1 5 and any degree of mental alteration encephalopathy in a patient without preexisting cirrhosis and with an illness of less than 26 weeks duration or chronic Childs Pugh C liver disease
4 Known preexisting non COVID 19 related hypercoagulability or another coagulopathy
5 Inability to maintain a mean arterial pressure of more or 65 mm Hg despite vasopressors and fluid resuscitation
6 Patients with known hypersensitivity to any component of the Hemopurifier
7 Lack of commitment for full medical support
8 Contraindications to extracorporeal blood purification therapy
such as
i Clinically relevant bleeding disorder
ii Contraindication to anti-coagulation
iii Pregnancy
iv Inability to establish functional vascular access
v Participation in another competing investigational drug device or vaccine trial
vi Administration of an angiotensin converting enzyme ACE
inhibitor in the previous 14 days
vii Platelet count less than 50000 cells microliter
9 Recent history of unstable or untreated intradialytic hypotension
10 Subject is currently enrolled in an investigational drug or device
trial Patient may be enrolled if they have received an investigational agent previously and it is more than 5 half lives since the last dose
11 Any condition that in the opinion of the investigator would preclude the subject from being a suitable candidate for enrolment such as end stage chronic illness with no reasonable expectation of survival to hospital discharge 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The goal of the study is to evaluate the use of the Hemopurifier device in
the treatment of SARS CoV 2 Virus Disease COVID-19 		 After each Hemopurifier treatment on day 1 to day 4 48 hours 96 hours 7 day 15 day and 28 day 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary objective is to evaluate efficacy of the Hemopurifier in
patients with COVID 19 based on in hospital morbidity and mortality  		 After each Hemopurifier treatment on day 1 to day 4 48 hours 96 hours 7 day 15 day and 28 day 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   10/11/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 This is a Treatment of SARS CoV 2 Virus Disease COVID 19 in Humans with Hemopurifier Device. The study population will be patients with COVID 19 who are severely affected or at high risk for severe disease. Up to 15 patients with COVID-19 infection confirmed by SARS-CoV-2 RT-PCR will be enrolled.The patient must have either a double lumen hemodialysis catheter an arteriovenous fistula or graft for treatment. Patients will receive a four hour treatment with the Hemopurifier extracorporeal therapy once daily for up to four days or until discontinued because of clinical improvement or deterioration or upon decision of the Principal Investigator. 
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