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CTRI Number  CTRI/2020/11/028779 [Registered on: 02/11/2020] Trial Registered Prospectively
Last Modified On: 29/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of SARS-CoV-2 Equine Antiserum Immunoglobulin (Purified F(ab)2 fragment) in hospitalised COVID-19 patients with moderate disease.  
Scientific Title of Study   A phase I, open label, parallel, randomised trial to assess the safety and efficacy of SARS-CoV-2 Equine Antiserum Immunoglobulin (Purified F(ab)2 fragment) in hospitalised COVID-19 patients with moderate disease in addition to standard of care. 
Trial Acronym  None 
Secondary IDs if Any  
Secondary ID  Identifier 
BECT063/Equine.CoV.Ab-Phase-I/CTP-01Ver: 1.1 dated:07.10.20   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subhash Thuluva 
Designation  Vice President - Clinical Development 
Affiliation  Biological E.Limited 
Address  Clinical affairs & Pharmacovigilance Dept, 2nd floor, Road No.35, Jubilee Hills

Hyderabad
TELANGANA
500033
India 
Phone  04071216248   
Fax  04027675309   
Email  subhash.thuluva@biologicale.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kishore TSA 
Designation  Associate Vice president - Clinical Development 
Affiliation  Biological E.Limited 
Address  Pharmacovigilance Dept, 2nd floor, Road No.35, Jubilee Hills

Hyderabad
TELANGANA
500033
India 
Phone  04071216247  
Fax  04027675309   
Email  kishore.turaga@biologicale.com  
 
Details of Contact Person
Public Query  
Name  Dr Kishore TSA 
Designation  Associate Vice president - Clinical Development 
Affiliation  Biological E.Limited 
Address  Pharmacovigilance Dept, 2nd floor, Road No.35, Jubilee Hills

Hyderabad
TELANGANA
500033
India 
Phone  04071216247  
Fax  04027675309   
Email  kishore.turaga@biologicale.com  
 
Source of Monetary or Material Support  
Biological E.Limited,18/1&3, Azamabad, Hyderabad - 500020, Telangana, India.  
 
Primary Sponsor  
Name  Biological ELimited 
Address  18/1&3, Azamabad, Hyderabad - 500020, Telangana, India.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandramani Singh   All India Institute of Medical Sciences   1st Floor, Room No. 17, Department of Community & Family Medicine, Aurangabad Road,Phulwari Sharif- 801507
Patna
BIHAR 		 09931733280

drcmsingh@aiimspatna.org 
Dr Venugopal  Visakha Institute of Medical Sciences(VIMS)  2nd Floor, Room No. 03, S.No.97/2, Dept of Medicine, Hanumanthuwaka, Chinagadilli Village-530040
Visakhapatnam
ANDHRA PRADESH 		 09866739808

fbnc.amc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics Committee, Visakha Institute of Medical Sciences, Visakhapatnam  Approved 
IEC, All India Institute of Medical Sciences, Patna   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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  SARS-CoV-2 (COVID-19) Antiserum Immunoglobulins (Purified F(ab)2 fragment along with standard of care   Patients in this group will receive two 4mL doses (at day 0 and Day 1) of BioE’s SARS-CoV-2 (COVID-19) Antiserum Immunoglobulins (Purified F(ab)2 fragment) intravenously along with standard of care. 
Comparator Agent  Standard care for Covid-19 patients  Patients in this group will receive only standard of care for Covid-19 patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Both male and female patients aged between 18-55 years who signed the informed consent.
2. Patients screened for Covid-19 by RT-PCR method ≤72 hours from the date
of RT-PCR confirmation and/or 7 days from the start of symptoms.
3. Respiratory Rate > 24 breaths/min and SpO2 ≤93% on room air
4. Patients screened for intradermal sensitivity testing prior to initiation of infusion. 
 
ExclusionCriteria 
Details  1.Pregnant women
2. Breastfeeding women
3. Known hypersensitivity to blood products and reactive to intradermal
sensitivity test prior to infusion
4. Receipt of pooled immunoglobulin in last 30 days
5. Critically ill patients:
a. Severe ARDS cases
b. Shock (Requiring Vasopressor to maintain a
MAP ≥ 65mmHg or MAP below 65)
6. Participating in any other clinical trial
7. Clinical status precluding infusion of blood
products
8. Patients are not suitable for transfusion
therapy;
9. Patients with severe pneumonia defined as: RR
≥30 times/min or oxygen saturation ≤ 90% in
resting state or PaO2/FiO2 ≤ 100 mmHg or
respiratory failure and mechanical ventilation
are required or shock occurs or ICU
monitoring with presence of other organ
failure;
10. Acute life-threatening organ dysfunction
caused by a dys-regulated host response to
suspected or proven infection. (Signs of organ
dysfunction include: altered mental status,
difficult or fast breathing, low oxygen
saturation, reduced urine output, fast heart
rate, weak pulse, cold extremities
or low blood pressure, skin mottling, or
laboratory evidence of coagulopathy,
thrombocytopenia, acidosis, high lactate or
hyperbilirubinemia).
11. Patients on any other immunoglobulin or
immunomodulatory treatment;
12. Patients with known history of allergy to
horse proteins or severe allergic reactions
to any component of the Equine antiserum; 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients with treatment-emergent adverse events including infusion related reactions  Day 0 Through Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Time to symptom resolution
a) Fever
b) Shortness of Breath
c) Fatigue 		 post enrolment  
Proportion of patients with clinical progression of disease on a WHO
clinical progression scale 		 assessed up to Day 28. 
Proportion of patients with RT-PCR negative outcome  At Day 14 and Day 28 
Change in oxygen requirement  Post Infusion 
Duration of respiratory support required
a. Duration of Invasive Mechanical Ventilation
b. Duration of Non-Invasive Ventilation 		 Post Enrolment 
Levels of bio-markers (CRP, IL6, LDH, Ferritin & D-Dimer)  pre and post
infusion 
All cause mortality rate  at Day 28. 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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   Phase 1 
Date of First Enrollment (India)   05/11/2020 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This is an open label, randomised controlled phase-I study to evaluate the safety and efficacy of 4.0 mL intravenous dose of Equine antisera Immunoglobulin (Purified F(ab’)2 fragment) against SARS-CoV-2 administered in two doses, 24 hours apart, in 18-55 year-old hospitalised patients suffering from moderate Covid-19 disease. 

A total of 72 eligible patients suffering from moderate Covid-19 disease will be equally randomised into one of the two treatment arms based on the screening and enrolment criteria set in the protocol. The patients in both the arms, will receive standard of care for Covid-19 and the patients in Equine antisera arm would additionally receive two 4mL intravenous doses (2 vials x 2mL each) of SARS-CoV-2 (COVID-19) Antiserum Immunoglobulins (Purified F(ab’)2 fragment) 24hrs apart for assessing the safety & efficacy.

The total duration of the study will be 31 days (3 days for screening + 28 days for post immunoglobulin infusion.The study will be conducted in compliance with GSR 227(E), ICH and Indian good clinical practice guidelines in force at the time of study conduct.


 
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