| CTRI Number |
CTRI/2023/01/048838 [Registered on: 09/01/2023] Trial Registered Prospectively |
| Last Modified On: |
06/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Asunercept for the treatment of patients with moderate to severe COVID-19 disease |
|
Scientific Title of Study
|
A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase III Trial to Evaluate the Efficacy of Asunercept for the Treatment of Hospitalized Patients with Moderate to Severe COVID-19 Disease |
| Trial Acronym |
ASUCOV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| APG101_CD_018, PA 2.0_FRA/IND/ITA/POL/ZAF-1; 26 July 2022 |
Protocol Number |
| APG101_CD_018_India-specific Addendum V 1.0 18 Oct 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thanuja Naidu |
| Designation |
Director Clinical Operations APAC and Country Manager India |
| Affiliation |
Pharm Olam International India |
| Address |
Pharm Olam International India Pvt Ltd No 15 KMJ Arcadia I
Floor
Industrial Main Road Koramangala 5th Block
Bangalore KARNATAKA
560 095 India
Pharm Olam International India Pvt Ltd No 15 KMJ Arcadia I
Floor
Industrial Main Road Koramangala 5th Block
Bangalore KARNATAKA
560 095 India
Bangalore
KARNATAKA
560095
India |
| Phone |
080-67182215 |
| Fax |
080-41105520 |
| Email |
Thanuja.Naidu@pharm-olam.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thanuja Naidu |
| Designation |
Director Clinical Operations APAC and Country Manager India |
| Affiliation |
Director Clinical Operations APAC and Country Manager India |
| Address |
Pharm Olam International India Pvt Ltd No 15 KMJ Arcadia I
Floor
Industrial Main Road Koramangala 5th Block
Bangalore KARNATAKA
560 095 India
Pharm Olam International India Pvt Ltd No 15 KMJ Arcadia I
Floor
Industrial Main Road Koramangala 5th Block
Bangalore KARNATAKA
560 095 India
KARNATAKA
560095
India |
| Phone |
080-67182215 |
| Fax |
080-41105520 |
| Email |
Thanuja.Naidu@pharm-olam.com |
|
Details of Contact Person
Public Query
|
| Name |
Thanuja Naidu |
| Designation |
Director Clinical Operations APAC and Country Manager India |
| Affiliation |
Director Clinical Operations APAC and Country Manager India |
| Address |
Pharm Olam International India Pvt Ltd No 15 KMJ Arcadia I
Floor
Industrial Main Road Koramangala 5th Block
Bangalore KARNATAKA
560 095 India
Pharm Olam International India Pvt Ltd No 15 KMJ Arcadia I
Floor
Industrial Main Road Koramangala 5th Block
Bangalore KARNATAKA
560 095 India
KARNATAKA
560095
India |
| Phone |
080-67182215 |
| Fax |
080-41105520 |
| Email |
Thanuja.Naidu@pharm-olam.com |
|
|
Source of Monetary or Material Support
|
| Apogenix AG
Im Neuenheimer Feld 584
69129 Heidelberg, Germany |
|
|
Primary Sponsor
|
| Name |
Apogenix AG |
| Address |
Im Neuenheimer Feld 584 69120 Heidelberg, Germany |
| Type of Sponsor |
Other [Biotechnical company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Pharm Olam International India Pvt Ltd |
No 15 KMJ Arcadia I Floor Industrial Main Road Koramangala 5th Block Bangalore KARNATAKA 560 095 India |
|
|
Countries of Recruitment
|
Austria
France
Georgia
Germany
India
Italy
Poland
South Africa
Spain |
|
Sites of Study
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrikant Deshpande |
Ashirwad Hospital and Research Centre |
Ashirwad Hospital and Research Centre
Maratha Section Near Jijamata Udhyan Ulhasnagar 421004 Maharashtra India
Thane
MAHARASHTRA |
918850280316
tejashree.patilresearch@gmail.com |
| Dr Sandeep Kumar Gupta |
Atharva Multispecialty Hospital and Research Centre |
Atharva Multispecialty Hospital and Research Centre
H4 Comm 2 Construction DIV-21 Avas Vikas Parishad
IIM Road Lucknow 226003
Uttar Pradesh India
Lucknow
UTTAR PRADESH |
916392468372
farheen@ossinc.org |
| Dr Chandra Shekar M |
Bangalore Medical College |
Bangalore Medical College
number 322 3rd Floor OPD Block Victoria Hospital
Fort, Krishna Rajendra Road
Bengaluru 560002 Karnataka India
Bangalore
KARNATAKA |
919844252189
harryraykar@yahoo.com |
| Dr Ambanna Gowda |
Citizen Hospital |
Citizen Hospital
number 14 second Main Dispensary Road
Kalasipalya Bangalore 560002
Karnataka India
Bangalore
KARNATAKA |
919980107723
vivatiqcr@gmail.com |
| Dr Meenakshi Bhattacahrya |
Govt Medical College and Hospital |
Govt Medical College and Hospital
second Floor Department of Medicine
Panchakki Road
Aurangabad 431 001 Maharashtra India
Aurangabad
MAHARASHTRA |
917385557807
samreen@dphsindia.com |
| Dr Yandrapati Gnana Sundara Raju |
King George Hospital |
King George Hospital Maharanipeta Visakhapatnam 530002 Andhra Pradesh India
Visakhapatnam
ANDHRA PRADESH |
918106637595
Chaitanyagalaxycrservices@gmail.com |
| Dr Gautam S |
KLES Dr. Prabhakar Kore Hospital |
KLES Dr Prabhakar Kore Hospital
Nehru Nagar J N Medical College Campus
Belagavi 590010 Karnataka India
Belgaum
KARNATAKA |
917406454769
shrutiqmedcrs@gmail.com |
| Dr Prakash Shende |
Spandan Hospital |
Spandan Hospital
Srnumber 19 3 Plot Number A1 Bhoir Plaza Dange Chowk Road Pune 411033 Maharashtra India
Pune
MAHARASHTRA |
917776884779
renuka.ravresearch@gmail.com |
| Dr Mahesh Sutariya |
Unity Trauma Center and ICU |
Unity Hospital Near D R World
Opp Raghuvir Business Empire
AaiMata Road Parvat Patiya
Surat 395 010 Gujarat India
Surat
GUJARAT |
9107405698000
vinod.vora.r@gmail.com |
| Dr Pravin Nagulal Soni |
Yashwantrao Chavan Memorial Hospita |
Yashwantrao Chavan Memorial Hospital Sant Tukaram Nagar Pimpri Pune 411018
Maharashtra India
Pune
MAHARASHTRA |
919673869944
krutikesh@dphsindia.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ashirwad Hospital & Research Centre Ethics Committee |
Approved |
| Citizen Hospital Institutional Ethics Committee |
Approved |
| Ethics Committee Bangalore Medical College &Research Institute |
Approved |
| IEC King George Hospital |
Submittted/Under Review |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Government Medical College Aurangabad |
Approved |
| Institutional Ethics Committee For Atharva Multispecialty Hospital and Research Centre |
Approved |
| Institutional Ethics Committee KLE University |
Approved |
| Institutional Ethics Committee, Lokmanya Medical Research Centre |
Approved |
| Unity Hospital Ethics Committee |
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 |
Asunercept |
APG101 (Asunercept) is a recombinant glycosylated fusion protein consisting of the extracellular
domain of human CD95 linked to the Fc domain of human IgG1 (CD95-Fc). Two CD95-Fc
polypeptide chains are covalently connected by disulfide bridges in the hinge region of the Fc
domain to form active APG101. 100 mg Asunercept (5 mL taken
from one vial) weekly
Route of administration: IV infusion, after preparation
according to instructions
Weekly infusions of 100 mg
Asunercept at d1, d8, d15, and
d22
Infusions to be administered
AFTER all other procedures for
this day have been conducted |
| Comparator Agent |
Placebo |
Saline (Sodium chloride [NaCl]) for infusion
0 mg Asunercept (0 mL) for weekly
placebo IV infusion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patient or his/her legal authorized representative (in case the patient is unable to give own consent due to his/her medical condition) has given informed consent to participate in the trial and to adhere to the procedures stated in the protocol.
The patient is a male or female adult aged ≥18 years at the time of giving informed consent.
The patient is admitted to a hospital (maximum 72 hours prior to randomization) due to COVID-19 and has a positive SARS-CoV-2 polymerase chain reaction (PCR) test.
The patient has clinical symptoms indicative of moderate or severe illness (corresponding to score 5 [oxygen by mask or nasal prongs] or 6 [oxygen by non-invasive ventilation or high flow] on the WHO 10-point clinical progression scale) with COVID-19 prior to trial treatment on d1: Radiologically confirmed pneumonia due to COVID-19 and/ or clinical signs suggestive of moderate/severe illness with COVID-19.
The patient is willing to follow effective measures of contraception during the trial.
|
|
| ExclusionCriteria |
| Details |
The patient is moribund or has an estimated life expectancy <1 month (e.g., terminal cancer, etc.).
The patient is pregnant or breastfeeding.
The patient is anticipated to be discharged from hospital within 48 hours.
The patient requires anti-inflammatory medicines beyond SoC (SoC are drugs that are approved for treatment of COVID-19. In addition, SoC comprises medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization).
The patient requires invasive mechanical ventilation.
The patient is known to have active tuberculosis.
The patient is known to have hereditary fructose intolerance.
The patient is known to have co-infection with Influenza viruses or other viral respiratory infections (respiratory syncytial virus [RSV], parainfluenza viruses, respiratory adenoviruses).
The patient was or is currently participating in any investigational clinical study, other than observational, within 30 days prior to enrollment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to sustained recovery, defined as sustained improvement (i.e.,
without decrease) of ≥2 points on the WHO 10-point clinical progression
scale or discharge from hospital followed by being alive and at home for
14 consecutive days prior to day (d) 56, whichever occurs first
|
14 consecutive days prior to day (d) 56, whichever occurs first
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
All-cause mortality or progression to invasive mechanical ventilation
(IMV) by d28 |
Timepoint(s) of evaluation of this end point: Day 1 to 28 |
|
|
Target Sample Size
|
Total Sample Size="636"
Sample Size from India="152"
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 3 |
|
Date of First Enrollment (India)
|
16/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/11/2022 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Trial APG101_CD_018 is a
prospective, multicenter, randomized, double-blind, placebo-controlled Phase
III trial to evaluate the efficacy of Asunercept for the treatment of
hospitalized patients with moderate to severe COVID-19 corresponding to score 5
or 6 on the WHO 10-point clinical progression scale (Grade 0-10). Patients will
be randomized in a 1:1 ration into two study arms: Asunercept will be given at
a dose of 100 mg intravenously (i.v.) once weekly for a period of 4 weeks (1
dose each on d1, d8, d15, and d22) in addition to the treatment recommended by
international, national, or local treatment guidelines (SoC) and will be
compared with the control arm (i.e., SoC + placebo). Approximately 640 patients
are planned to be enrolled in nine countries and a total of up to 50 study
sites; 10 sites will participate in India. The primary endpoint is time to
sustained recovery, defined as sustained improvement (i.e., without decrease) of
≥2 points on the WHO 10-point clinical progression scale or discharge from
hospital followed by being alive and at home for 14 consecutive days prior to
day (d) 56, whichever occurs first. The key secondary endpoint is all-cause
mortality or progression to invasive mechanical ventilation (IMV) by day 28
after randomization. |