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CTRI Number  CTRI/2021/01/030533 [Registered on: 18/01/2021] Trial Registered Prospectively
Last Modified On: 15/01/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Sildenafil Use in Covid-19 Patients - A Pilot Study 
Scientific Title of Study   Sildenafil Use in Covid-19 Patients - A Pilot Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saajan Joshi 
Designation  Anesthesiologist 
Affiliation  Sardar Vallabh Bhai Patel Covid Hospital, Ulan Bater Road, Delhi Cantt, New Delhi 
Address  Department of Anesthesiology and Critical Care, Command Hospital Eastern Command, Alipore Road, Kolkata

Kolkata
WEST BENGAL
700027
India 
Phone  9599699348  
Fax    
Email  joe21sf@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Saajan Joshi 
Designation  Anesthesiologist 
Affiliation  Sardar Vallabh Bhai Patel Covid Hospital, Ulan Bater Road, Delhi Cantt, New Delhi 
Address  Department of Anesthesiology and Critical Care, Command Hospital Eastern Command, Alipore Road, Kolkata

Kolkata
WEST BENGAL
700027
India 
Phone  9599699348  
Fax    
Email  joe21sf@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Saajan Joshi 
Designation  Anesthesiologist 
Affiliation  Sardar Vallabh Bhai Patel Covid Hospital, Ulan Bater Road, Delhi Cantt, New Delhi 
Address  Department of Anesthesiology and Critical Care, Command Hospital Eastern Command, Alipore Road, Kolkata

Kolkata
WEST BENGAL
700027
India 
Phone  9599699348  
Fax    
Email  joe21sf@gmail.com  
 
Source of Monetary or Material Support  
Sardar Vallabh Bhai Patel Covid Hospital, Ulan Bater Road, Delhi Cantt, New Delhi - 110010 
 
Primary Sponsor  
Name  Sardar Vallabh Bhai Patel Covid Hospital 
Address  Ulan Bater Road Delhi Cantt New Delhi 110010 
Type of Sponsor  Other [Government Covid Hospital] 
 
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 
Saajan Joshi  Sardar Vallabh Bhai Patel Covid Hospital  Intensive Care Unit and High Dependency unit, Department of Anesthesiology and Critical Care, Ulan Bater Road, Delhi Cantt. New Delhi
South West
DELHI 
9599699348

joe21sf@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE ARMY HOSPITAL RESEARCH AND REFERRAL DELHI CANTT  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 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Tablet Sildenafil  Tablet Sildenafil will be administered orally or through nasogastric tube, thrice a day in the maximum dose of 0.1 grams/day. It will be commenced in the dose of 20 mg BD and would be gradually increased to 30 mg tds in 3-4 days, keeping in view hemodynamic stability. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Established case of Covid-19 (RTPCR +ve)
2. Moderate Covid-19 patients (SpO2 90 – 94% on room air, RR 24 – 30/min) with visible radiographic features of pneumonia
3. Severe Covid-19 patients (SpO2 < 90% on room air, RR>30/min) with visible radiographic features of pneumonia
 
 
ExclusionCriteria 
Details  1. Pregnant and lactating women
2. Patients on Nitrate medications in any form
3. Patients with any malignant tumor
4. Patients with heart ailments including Myocardial Infarction (in < 6 months) or heart failure.
5. Patients with mental illness or stroke (< 6months)
6. Advanced liver or kidney ailment
7. Patients with known history of severe systemic hypertension especially if uncontrolled
8. Patients with systemic hypotension because of any reason.
9. Patients allergic to Sildenafil
10. Patients already on mechanical ventilation
11. Patients with inability to take drug orally or inability to place Ryle’s tube.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To observe Sildenafil effect on Covid-19 progression including clinical findings, oxygenation and radiological findings  Three weeks or hospital discharge or death whichever is first 
 
Secondary Outcome  
Outcome  TimePoints 
1) To observe Sildenafil effect on inflammatory markers (CRP, D-Dimer, IL-6, Procalcitonin) and need for ventilation
2) To monitor any adverse events related to Sildenafil use
 
Three weeks or hospital discharge or death 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   25/01/2021 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   WILL BE PUBLISHED AFTER APPROPRIATE STATISTICAL ANALYSIS 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  through e mail

  6. For how long will this data be available start date provided 25-01-2021 and end date provided 25-04-2021?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Coronavirus disease 2019 (COVID-19) is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It’s first case was identified in WuhanChina, in December 2019 and  has since spread worldwide, leading to an ongoing pandemic with 8,55,02,084 confirmed cases and 18,50,605 deaths so far. India, with more than 10 million confirmed cases presently stands at number 2 in the world, with no territory spared of this infection and 1,49,686 deaths till date. The pandemic represents an unprecedented challenge for the investigators to offer safe and appropriate treatment strategies for its causative enveloped RNA beta coronavirus which has been shown to use the angiotensin-converting enzyme 2 (ACE2) receptor for cell entry (ACE2 receptors are predominantly expressed in endothelial cells, perivascular pericytes and type 2 cells in lungs).It’s amply clear now that COVID-19 syndrome is a thrombo-inflammatory process that initially affects pulmonary perfusion, but consecutively affects multiple organs in the body. Sildenafil, which is a phosphodiesterase 5 (PDE5) enzyme inhibitor and is used in the management of pulmonary hypertension, has also been found to have anti-inflammatory action owing to it’s ability to inhibit inducible Nitric Oxide Synthase (iNOS) enzyme. It is a potential agent  being investigated for it’s role in decreasing COVID-19 related morbidity and mortality. With a few studies being conducted elsewhere globally, we too intend to carry out a pilot investigation to assess the role of oral Sildenafil in influencing the disease outcome in SARS-CoV-2 infected population in this part of the world, admitted at our centre.

 

 
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