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CTRI Number  CTRI/2020/04/024948 [Registered on: 30/04/2020] Trial Registered Prospectively
Last Modified On: 30/04/2020
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 to Study the Effects of Hydroxychloroquine, Ciclesonide and Ivermectin in treatment of moderate COVID-19 illness 
Scientific Title of Study   EFFICACY OF HYDROXYCHLOROQUINE, CICLESONIDE AND IVERMECTIN IN TREATMENT OF MODERATE COVID-19 ILLNESS: AN OPEN-LABEL RANDOMISED CONTROLLED STUDY 
Trial Acronym  EHYCIVER-COVID 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anupam Prakash 
Designation  Professor of Medicine 
Affiliation  LADY HARDINGE MEDICAL COLLEGE 
Address  Department of Medicine Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi 110001 INDIA

New Delhi
DELHI
110001
India 
Phone  8588885305  
Fax    
Email  prakashanupam@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anupam Prakash 
Designation  Professor of Medicine 
Affiliation  LADY HARDINGE MEDICAL COLLEGE 
Address  Department of Medicine Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi 110001 INDIA


DELHI
110001
India 
Phone  8588885305  
Fax    
Email  prakashanupam@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Anupam Prakash 
Designation  Professor of Medicine 
Affiliation  LADY HARDINGE MEDICAL COLLEGE 
Address  Department of Medicine Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi 110001 INDIA


DELHI
110001
India 
Phone  8588885305  
Fax    
Email  prakashanupam@hotmail.com  
 
Source of Monetary or Material Support  
Dr Anupam Prakash Professor, Department of Medicine Lady Hardinge Medical College New Delhi 
 
Primary Sponsor  
Name  Lady Hardinge Medical College 
Address  Shaheed Bhagat Singh Marg New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anupam Prakash  Department of Medicine  Room No 1014 Smt Sucheta Kriplani Hospital Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi 110001
New Delhi
DELHI 
8588885305

prakashanupam@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Lady Hardinge Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  B972||Coronavirus as the cause of diseases classified elsewhere, B338||Other specified viral diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ciclesonide  200 mcg bid for 7 days 
Intervention  Hydroxychloroquine  400 mg bid Day1 followed by 200 mg bid on Days 2 to 7 
Intervention  Ivermectin  12 mg OD for 7 days 
Comparator Agent  Standard of Care  Supportive management as per national guidelines 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  • Adult patients (≥18years) suffering from Covid-19. A positive throat swab (by real time PCR) obtained from a patient suspected to be Covid-19 or from a contact (or HCW) of Covid-19 patient will be considered to be a Covid-19 case.
• Presence of moderate Covid-19 disease (10) as defined by presence of pneumonia (clinical and radiological signs) with respiratory rate between 15 to 30/minute and/or SpO2 90%-94% on room air.
 
 
ExclusionCriteria 
Details  • Patients with renal or hepatic dysfunction (Serum creatinine > 1.5 mg/dL and serum transaminase levels >120 U/L)
• Patients with clinical heart failure/known CAD
• Known cases of neoplasms or immunodeficiency syndromes
• Patients who are on chemotherapy, immunosuppressive agents, steroids or antiviral agents, or have received in the preceding 4 weeks
• Pregnant and lactating patients
• Uncooperative patients (in the opinion of the investigator, if it is difficult to ensure patient cooperation during the study)
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients having virologic cure on Day 6 in each of the groups  Day 6 of treatment initiation 
 
Secondary Outcome  
Outcome  TimePoints 
o Proportion of patients having resolution of symptoms/signs on Day 7 and Day 14, in each of the groups
o The individual proportion of the aforementioned rescue criteria in each of the groups.
o Side-effects noted in each of the group
 
Day 7 and Day 14 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 2 
Date of First Enrollment (India)   15/05/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Brief Summary  

Principal Investigator:

Dr. Anupam Prakash,

Professor of Medicine, Lady Hardinge Medical College, New Delhi,

On behalf of the LHMC Medicine COVID-19 Investigator Group

Place of study:

Department of Medicine, Lady Hardinge Medical College and associated Hospitals, New Delhi.

Duration of study: May-October 2020

Type of study: Randomised controlled study.

The world is facing the crisis created by COVID-19, a pandemic of unassumed proportions, which does not have any known treatment yet. Several drugs are being repositioned to see their efficacy for Covid-19. This study is planned to study the efficacy of oral hydroxychloroquine, inhalational ciclesonide and oral ivermectin as treatment option in adult patients (≥18 years) with moderate Covid-19 illness.

Moderate Covid-19 illness will be defined as nasopharyngeal/nasal/oropharyngeal swab positivity by PCR, along with respiratory rate of 15-30/min and SpO2 between 90-94%. Those fitting the inclusion and exclusion criteria, will be enrolled after obtaining an informed written consent, and randomized (by draw of lots) to any of the 4 arms-

(i)            Group A - Hydroxychloroquine 400 mg bid oral Day 1, 200 mg bid on Day 2-7

(ii)          Group B –Ciclesonide 200 mcg bid (through rotahaler) for 7 days

(iii)         Group C –Ivermectin 12 mg orally OD for 7 days

(iv)         Group D –Standard of care only

A sample size of 30 in each arm is proposed to be included over a period of 6 months. A focused physical examination (General appearance and behaviour including mental status, vitals and chest examination) will be performed for each subject enrolled in the study. Routine blood and radiological investigations would be performed for each subject, and an ECG just after admission, and prior to satisfactory discharge. All patients recruited will anyway receive standard of care, and the institutional/national management protocol will be followed in all other respects. Enrolled subjects will be followed up for virologic cure (primary outcome). Repeat PCR testing on fresh swab would be done on Day 6 onwards and two consecutive negative throat swabs at least 24 hours apart would constitute virologic cure (primary outcome). Any positive throat swab on Day 6 onwards, would entail repeat testing after 48 hours. Trial drug would be continued in each group (A, B and C) would be continued for a period of 7 days, though follow-up will be for a period of virologic cure, to a maximum of 14 days. Trial drug would be withdrawn if they deteriorate to severe Covid-19 illness or disseminated intravascular coagulation (DIC) or shock. However, they will be included for the purpose of analysis.

Secondary outcomes include (1) Proportion of patients having resolution of symptoms/signs on Day 7 and Day 14 in each of the groups, (ii) Subjects deteriorating in to severe Covid-19 or developing DIC/shock, (iii) Side-effects observed in each of the group.

The comparative analysis will be performed using ANOVA testing, and the reporting would be done as per CONSORT guidelines.

 
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