CTRI/2024/10/075314 [Registered on: 15/10/2024] Trial Registered Prospectively
Last Modified On:
08/09/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A clinical trial of Aviptadil for the evaluation of its efficacy and safety in patients with acute respiratory distress syndrome.
Scientific Title of Study
A multi-centric, open-label, comparative, randomized, phase 3 trial to evaluate the efficacy and safety of Aviptadil as an add-on treatment to the Standard of Care in acute respiratory distress syndrome.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/SND/14/2024; Date: 07 Oct 2024
DCGI
ZUV/Aviptadil/08/2023; Version 1.0; Date: 08 Jan 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
OPD Room No. 01, Ground Floor, 53/128, Y Block, Naubasta, Kanpur, Uttar Pradesh- 208011, India Kanpur Nagar UTTAR PRADESH
8077572980
arjunbhatnagar02@gmail.com
Dr Satish Patil
Belagavi Institute of Medical Sciences
New ICU, First Floor,
Dr. B. R. Ambedkar Road, Sadashiv Nagar, Belagavi (Belgaum) Karnataka - 590001 India Belgaum KARNATAKA
9448112040
drsbpatilbgm@gmail.com
Dr Rajesh Kumar Pande
BLX MAX Centre for Critical Care
Principal Director & HODs room/ Medical ICU, BLK MAX Centre for Critical Care, 3rd Floor, Near Rajendra Place, 5-Pusa Road, New Delhi 110005 Central DELHI
9810536268
drrajeshpande@blkhospital.com
Dr Shweta Ram Chandankhede
Care Hospital
Department of Clinical Research, Basement 1, HM Building,
#6-3-248/2, Road No.1, Banjara Hills, Hyderabad, Telangana-500034 Hyderabad TELANGANA
9963431945
shwets0106@gmail.com
Dr Mohammad Shameen
Jawaharlal Nehru Medical College and Hospital
Ward 13, Department of TB and Respiratory Disease, Aligarh Muslim University, Aligarh, 202002 Aligarh UTTAR PRADESH
9412731835
mshameem@myamu.ac.in
Dr Madhav Prabhu
Jawaharlal Nehru Medical College and KLEs Dr. Prabhakar Kore Hospital and MRC
Department of Critical Care and Emergency Services, 4th Floor, 1F, Raja Subodh Chandra Mallick Road, Jadavpur, Kolkata, West Bengal- 700032 India Kolkata WEST BENGAL
9038838000
ahsancalcutta@yahoo.com
Dr Amitabha Saha
Manipal Hospital
HODs room, Department of Critical Care, 223 & 230 Barkohala Lane, Purba Jadavpur, Mukundapur, Kolkata - 700099 Kolkata WEST BENGAL
9830177784
drasaha0401@gmail.com
Dr Kapil Zirpe
Ruby Hall Clinic
NTU-2, Neurology Department, 2nd Floor, Main Ruby Hall Clinic Building, Near Pune Railway Station, Sasoon Road, Sangamvadi, Pune, 411001 Pune MAHARASHTRA
9822844212
kapilzirpe@gmail.com
Dr Bal Kishan Gupta
S. P. Medical College and A. G. Hospital
MOPD Room No. 16, MICU, Near Maharaja CT MRI Center, H Ward for Male, I ward For Female, Ground Floor, SPMC and PBM Hospitals, Bikaner, Rajasthan, 334003 Bikaner RAJASTHAN
9829176143
bkgbkn@rediffmail.com
Dr Kapil Borawake
Sahyadri Super Speciality Hospital
Critical Care Department, Sr. No. 163, Bhosale Garden Rd, Bhosale Nagar, Hadapsar,
Pune, 411028 Pune MAHARASHTRA
9765634036
drkapilb@gmail.com
Dr Subhal Dixit
Sanjeevan Hospital
OPD No 3, Ground floor, Plot No. 23, Off Karve Road, Kashibai Khilare Path, Erandwane, Pune 411004 Pune MAHARASHTRA
9822050240
subhaldixit@yahoo.com
Dr Rahul Pandit
Sir H. N. Reliance Foundation Hospital and Research Centre
Critical Care Medicine Department, 13th & 14th Floor, Tower Building, Prarthana Samaj, Raja Ram Mohan Roy Road, Girgaon, Mumbai, Maharashtra- 400004, India Mumbai MAHARASHTRA
Dr. N S Sawant ICU (1st floor) & Nargis Dutt ICU (2nd floor), Department of Anesthesiology, Critical Care & Pain, Main Building, Dr. E Borges Road, Parel (E), Mumbai 400012 Mumbai MAHARASHTRA
Aviptadil will be administered by infusion pump with 12-hour intervals at ascending doses on 3 successive days. Patients will receive 0.166 mcg/kg/hr of Aviptadil on Day 1, 0.332 mcg/kg/hr on Day 2 and 0.498 mcg/kg/hr on Day 3.
Comparator Agent
Standard of Care
The Standard of Care will be as per hospital ICU protocol.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Patients with >18 years of age.
2. Patients with ARDS, confirmed by the New Global Definition of ARDS, 2024 based on the following diagnostic criteria.
2a). Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS.
2b). Patients with bilateral opacities not fully explained by effusions, lobar/ lung collapse, or nodules on High-resolution computed tomography (HRCT).
2c). Patients with respiratory failure not fully explained by cardiac failure or fluid overload; If no risk factor for ARDS is identified, hydrostatic edema must be excluded by objective measures (e.g., echo-cardiography).
2d). Patients with one of the oxygenation criteria:
PaO2/FiO2 ratio ≤ 300mmHg with positive end-expiratory pressure (PEEP) at least 5 cmH2O
OR
SpO2:FiO2 ≤ 315 (if SpO2 ≤97%) on HFNO with flow of ≥30 L/min or NIV/CPAP with PEEP at least 5 cmH2O.
3. Obtained informed consent for participation in the study from the patients or legally acceptable representative
ExclusionCriteria
Details
1. Patients with mechanical ventilation for more than 48 hours prior to ARDS diagnosis.
2. Patients with congestive heart failure.
3. Patients with acute left ventricular failure.
4. Patients with liver failure (Child Pugh grade C).
5. Patients with chronic renal failure requiring renal dialysis therapy.
6. Patients who have burns more than 20% of total body surface area.
7. Patients after resuscitation from cardiac arrest.
8. Patients with a history of hypersensitivity to the anticoagulants.
9. Patients with more than 3 watery stools within 24 hours.
10. Pregnant or lactating women.
11. Decision of the investigator that participation in the study is not in the best interest of the patient or any condition that prevents the safe adherence to the protocol.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Improvement in PaO2/FiO2 ratio.
Baseline and on post-treatment day 1, 2, 3, 4, 5, 6, 7.
Secondary Outcome
Outcome
TimePoints
Survival rate
Baseline to post-treatment day 7
Oxygenation Index
Baseline, post-treatment day 1, 4 and 7
Change in Sequential Organ Failure Assessment (SOFA) score
Baseline, post-treatment Day 4 and 7
Duration of stay in hospital
baseline to post-treatment day 7
Incidences of adverse events
Baseline to post-treatment day 7
Target Sample Size
Total Sample Size="240" Sample Size from India="240" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Vasoactive Intestinal Peptide (VIP) was awarded an Orphan Drug Designation in 2001 by the USFDA for the treatment of Acute Respiratory Distress Syndrome (ARDS). Aviptadil, a synthetic form of human VIP was awarded Orphan Drug Designation for the treatment of Pulmonary Arterial Hypertension (in 2005 by USFDA), Acute Lung Injury (in 2006 by EMA), and Sarcoidosis (in 2007 by EMA and in 2020 by USFDA). Aviptadil has been studied in respiratory disease conditions like asthma, acute lung injury, pulmonary arterial hypertension, sarcoidosis and idiopathic pulmonary fibrosis. Recent clinical studies conducted in the USA and India have shown encouraging results in ARDS associated with COVID-19 patients in terms of reduction in mortality rate and hospital stay. Aviptadil was approved by DCG(I) in India for the management of ARDS in severe COVID-19 patients. After considering the role of Aviptadil, this trial was designed to evaluate the efficacy and safety of Aviptadil in ARDS patients with diverse etiology.