FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036828 [Registered on: 24/09/2021] Trial Registered Prospectively
Last Modified On: 29/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study of Ampion in adults with respiratory distress due to COVID-19.  
Scientific Title of Study   A Randomized, Double-Blinded, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults with Respiratory Distress due to COVID-19. 
Trial Acronym  AP019 
Secondary IDs if Any  
Secondary ID  Identifier 
AP-019 Version 1.2, 25 May 2021.  Protocol Number 
NCT04868890  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Himanshu S Pophale 
Designation  Professor and HOD. 
Affiliation  Department of Pulmonology 
Address  Smt. Kashibai Medical College and General Hospital, Department of Pulmonology,
S.No, 49/1, Mumbai Pune Bypass Rd, Narhe Pune, Maharashtra-411041
Pune
MAHARASHTRA
411041
India 
Phone  020-24106178  
Fax    
Email  himanshupophale@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Mr Bipin Gupta 
Designation  Clinical Project Manager 
Affiliation  Department of Clinical Operation 
Address  QED Clinical Services India Private Limited
Clinical Operations Office number B-209, Westgate, Besides YMCA Club S. G. Highway Ahmadabad GUJARAT India
Ahmadabad
GUJARAT
380015
India 
Phone    
Fax    
Email  bgupta@orphan-reach.com  
 
Details of Contact Person
Public Query  
Name  Mr Gajendrasinh Chanchu 
Designation  Associate Director 
Affiliation  Department of Clinical Operation 
Address  QED Clinical Services India Private Limited
Clinical Operations Office number B-209, Westgate, Besides YMCA Club S. G. Highway Ahmadabad GUJARAT India
Ahmadabad
GUJARAT
380015
India 
Phone    
Fax    
Email  gchanchu@orphan-reach.com  
 
Source of Monetary or Material Support  
Ampio Pharmaceuticals, Inc. 373 Inverness Parkway Englewood, CO 80112  
 
Primary Sponsor  
Name  Ampio Pharmaceuticals Inc 
Address  373 Inverness Parkway,Englewood, CO 80112 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
QED Clinical Services India Private Limited  B-209, Westgate, Besides YMCA Club, S. G. Highway, Ahmedabad, Gujarat India 380015. 
 
Countries of Recruitment     India
United States of America  
Sites of Study  
No of Sites = 10  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rakesh Pandit  Akash Healthcare Pvt Ltd  Akash Healthcare Pvt Ltd, Hospital Plot, Road No 201, Sector-3, Dwarka, New Delhi - 110075
New Delhi
DELHI 		 9811043326

drrakesh.pandit@aakashhealthcare.com 
Dr Arunkumar Radhakrishnan  Chettinad Hospital and Research Institute  Department of Pharmacology, Chettinad Hospital and Research Institute, Rajiv Gandhi Salai road, Mahabalipuram, Kellambakkam, Chennai - 603103
Chennai
TAMIL NADU 		 9884212634

drarunresearch2020@gmail.com 
Dr Vinod PB  Elite Mission Hospital  Elite Mission Hospital, Koorkkencherry, Thrissur - 680007, Kerala
Thrissur
KERALA 		 9645536701

drvinodpbaburajan1989@gmail.com 
Dr Atul Vijayrao Rajkondawar  Government Medical College and Hospital  Department of Medicine, Government Medical College and Hospital, Near Hanuman Nagar, Medical Square, Ajani road, Nagpur-440003
Nagpur
MAHARASHTRA 		 9373215775

atul.rajkondawar@gmail.com 
Dr Khumukcham Lokeshwar  Jawaharlal Nehru Institute of Medical Sciences  Department of Medicine, Jawaharlal Nehru Institute of Medical Sciences, Porompat, Imphal-East - 795005, Manipur
Imphal East
MANIPUR 		 8258919544

lokeshwarsingh57@gmail.com 
Dr Mahesh PA  JSS Hospital  Department of Respiratory Medicine, JSS Hospital, Mahatma Gandhi Road, Mysuru - 570004, Karnataka
Mysore
KARNATAKA 		 9448044003

mahesh1971in@yahoo.com 
Dr Reema Kashiva  Noble Hospital  Department of Medicine, Noble Hospital, Magarpatta city road, Hadapsar, Pune 411013, Maharashtra
Pune
MAHARASHTRA 		 9922618286

reemakashiva@gmail.com 
Dr Nirav Bhalani  Rhythm Heart Institute  Rhythm Heart Institute, Nr Siddharth Bunglows, Sama-Savli road, Vadodara - 390022, Gujarat
Vadodara
GUJARAT 		 9727166471

trial@rhythheart.com 
Dr Sudhir Bhandari  SMS Medical college and attached hospitals  Department of Medicine, SMS Medical college and attached hospitals, JLN Marg, Jaipur - 302004, Rajasthan
Jaipur
RAJASTHAN 		 9829078844

drs_bhandari@yahoo.com 
Dr Himanshu Shrikant Pophale  Smt. Kashibai Navale Medical College & General Hospital  Department of Respiratory Medicine, Smt. Kashibai Navale Medical College & General Hospital, S.no. 49/1, Mumbai-Pune bypass road, Narhe Pune - 411041 Maharashtra
Pune
MAHARASHTRA 		 7738363741

himanshupophale@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 10  
Name of Committee  Approval Status 
Akash Healthcare Institutional Ethics Committee  Approved 
Ethics Committee, JSS Hospital  Approved 
Institutional Ethics Committee JNIMS  Not Applicable 
Institutional Ethics Committee of Smt. Kashibai Navale medical college and general Hospital  Approved 
Institutional Ethics Committee, Elite Mission Hospital  Approved 
Institutional Ethics Committee, Government Medical College and Hospital  Not Applicable 
Institutional Human Ethics Committee, Chettinad Academy of Research and Education  Approved 
Noble Hospital Clinical Research Department  Approved 
Rhythm Heart Institute Ethics Committee  Approved 
The Ethics Committee, SMS Medical College & attached Hospitals  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  Ampion  Participants in the active arm will inhale nebulized Ampion (8 mL) administered four times daily for 5 days. Nebulized drug will be delivered using the Aerogen Solo Nebulizer System with the Aerogen Solo Adaptor (FDA 510K K133360) manufactured by Aerogen Limited, Galway, Ireland. 
Comparator Agent  Placebo  Participants in the control arm will inhale nebulized placebo (8 mL) administered four times daily for 5 days. Nebulized placebo will be delivered using the Aerogen Solo Nebulizer System with the Aerogen Solo Adaptor (FDA 510K K133360) manufactured by Aerogen Limited, Galway, Ireland.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female, ≥ 18 years old
2. Diagnosed with SARS-CoV2, as confirmed using a standard RT-PCT assay or an equivalent test.
3. Baseline severity categorization of severe or critical COVID-19 infection per FDA Guidance for developing drugs and biological products for COVID-19 (February 2021):
a) Severe COVID-19:
• Symptoms suggestive of severe systemic illness with COVID-19, which could include shortness of breath or respiratory distress.
• Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥ 30 per minute, heart rate ≥ 125 per minute, SpO2 ≤ 93% on room air at or PaO2/FiO2 < 300.

b) Critical COVID-19:
• Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered
• Non-invasive mechanical or endotracheal mechanical ventilation via reinforced cannula at flow rates > 20 L/min with fraction of oxygen ≥ 0.5)

4. Informed consent obtained from the patient or the patients legal representative
 
 
ExclusionCriteria 
Details  1.As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments.
2. Clinical diagnosis of respiratory failure requiring ECMO and/or therapy is not available due to limitation.
3. Shock defined by systolic blood pressure <90 mm Hg, or diastolic blood pressure <60 mm Hg or requiring vasopressors.
4. Multi-organ dysfunction/failure.
5. Patient has severe chronic obstructive or restrictive pulmonary disease (COPD) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.).
6. Patient has chronic conditions requiring chemotherapy or immunosuppressive medication
7.A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (N- acetyltryptophan, sodium caprylate).
8. Prolonged QT interval.
9. Patient has known pregnancy or is currently breastfeeding.
10. Patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception.
11. Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage of participants with a successful outcome (life) or unsuccessful outcome (death) by Day 28.  To be assessed by Day 28 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of adverse events (AEs) and serious adverse events (SAEs)   To be assessed from baseline to day 60 
Hospital length of stay (LOS)  From admission (baseline) to discharge 
Change in baseline in oxygen use, blood oxygen saturation, and oxygen flow rate  To be assessed from baseline through Day 5. 
Percentage of participants who progress to respiratory failure (i.e., need for mechanical ventilation, ECMO, non-invasive ventilation)  To be assessed by day 28. 
Percentage of participants who require Intensive Care Unit (ICU)   To be assessed by day 28

 
Change in ordinal scale  To be assessed from baseline through Day 5. 
Change in NEWS2 score

Modulation of cytokine levels 		 To be assessed from baseline to Day 5.
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "129"
Final Enrollment numbers achieved (India)="69" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   16/10/2021 
Date of Study Completion (India) 13/04/2022 
Date of First Enrollment (Global)  03/05/2021 
Date of Study Completion (Global) 30/04/2022 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has resulted in the pandemic spread of coronavirus disease 2019 (COVID-19), which has a high rate of infection, has a high rate of hospitalization, has overwhelmed healthcare systems, and can be fatal.

Ampion is the low molecular weight filtrate of human serum albumin with the in vitro ability to modulate inflammatory cytokine levels. Ampion has the potential to improve clinical outcomes for COVID-19 patients by reducing inflammatory cytokines correlated with the disease and respiratory complications, such as Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).

 This study aims to evaluate the effects of Ampion on mortality and clinical outcomes in patients with respiratory distress due to COVID-19.

 
Close