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CTRI Number  CTRI/2020/08/027394 [Registered on: 26/08/2020] Trial Registered Prospectively
Last Modified On: 24/08/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of response of ivermectin on virological clearance in COVID 19 patients 
Scientific Title of Study   Assessment of response of ivermectin on virological clearance in COVID 19: single centre, open labelled, randomised controlled trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ROMIT SAXENA 
Designation  Assistant Professor  
Affiliation  Maulana Azad Medical College 
Address  Maulana Azad Medical College, Bahadur Shah Zafar Road
Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India 
Phone    
Fax    
Email  drromit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ROMIT SAXENA 
Designation  Assistant Professor  
Affiliation  Department of Pediatrics, Maulana Azad Medical College 
Address  Department of Pediatrics, Maulana Azad Medical College, Bahadur Shah Zafar Road , New Delhi
Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India 
Phone    
Fax    
Email  drromit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ROMIT SAXENA 
Designation  Assistant Professor  
Affiliation  Department of Pediatrics, Maulana Azad Medical College 
Address  Department of Pediatrics, Maulana Azad Medical College, Bahadur Shah Zafar Road , New Delhi
Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI
110002
India 
Phone    
Fax    
Email  drromit@gmail.com  
 
Source of Monetary or Material Support  
no monetary support for the study. Study is being conducted at Department of Pediatrics, Maulana Azad Medical college and associated Lok Nayak Hospital 
 
Primary Sponsor  
Name  not applicable  
Address  not applicable 
Type of Sponsor  Other [not applicable] 
 
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 
Dr Romit Saxena   maulana azad medical college and associated LN hospital   Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI 
9597650364

drromit@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee, Maulana Azad medical college   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  A00-B99||Certain infectious and parasitic diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  administration of drug ivermectin for patients of mild or moderate COVID and assess response on virological clearance   administration of drug ivermectin for patients of mild or moderate COVID and assess response on virological clearance . The drug will be administered as a single dose at dose of 0.2 mg/kg as per institutional protocols. It will not be repeated.  
Comparator Agent  no ivermectin administration , rest all patients, will receive treatment as per departmental protocol, which may include, vitamin C, Zinc, antipyretic, ranitidine/omeprazole/chloroquine , azithromycin etc. The only exception is the use of ivermectin, which will be used in the study group and not in the control group  no ivermectin administration , rest all patients, will receive treatment as per departmental protocol, which may include, vitamin C, Zinc, antipyretic, ranitidine/omeprazole/chloroquine , azithromycin etc. The only exception is the use of ivermectin, which will be used in the study group and not in the control group 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients admitted with COVID 19 , positive report, or are detected as positive after admission
2. Present within 5 days of symptom onset
3.The patient must be between the ages >5 years and 15 Kg, until 65 years of age
4.Women in child bearing age(14-50 years) within 14 days of LMP only
5.Mild-moderate symptoms at presentation as per Ministry of Family welfare, Government of India definitions
 
 
ExclusionCriteria 
Details  1. Known history of ivermectin allergy
2. Hypersensitivity to any component of ivermectin
3. Refusal of consent (Appendix 5 and 6).
4. Co-morbidities e.g. Acute or chronic renal disease , History of coronary disease , pregnancy, History of cerebrovascular disease and malignancy
5. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Concomitant use of critical CYP3A4 substrate drugs such as warfarin.
6.Prior use of ivermectin in last 15 days
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
PRIMARY OBJECTIVE
To assess the Efficacy of single dose of Ivermectin, given within first 5 days of symptom onset, as assessed by RT PCR for SARS CoV 2, at 3rd and 7th day after start of treatment 
At Admission, 3rd and 7th Day after start of treatment
 
 
Secondary Outcome  
Outcome  TimePoints 
Viral load as determined by PCR cycle threshold on Day 3 and Day 7(since ivermectin administration ).   DAy 0, Day 3 and Day 7  
Symptom resolution as assessed everyday till 7 days of admission and progression across clinical staging   Everyday for 1st 7 days  
Telephonic conversation at 21 day from day of administration of drug, to assess any residual symptoms.   21st day after administration of dose  
Assess the safety profile of the drug  Everyday for 1st 7 days  
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   02/09/2020 
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="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   publication after study is completed  
Brief Summary  

On Dec 31, 2019, WHO was informed of a cluster of unexplained cases of pneumonia in Wuhan, Hubei province, China (1,2,3,4). The World Health Organization (WHO) has described this disease process, called as COVID-19 (Coronavirus disease-2019).  There is an urgency of developing a therapeutic strategy in order to control the spread of COVID-19(5). Ivermectin is FDA approved drug, known to have wide-spectrum antiviral activity against number of viruses under in vitro conditions (5,6,7,8,9). The drug has an excellent safety profile, and has been used for more than 30 years with an excellent safety profile. More than 2.7 billion doses have been distributed both as individual treatment and as control of neglected tropical diseases (NTDs) at the approved dose of 150–200 μg/kg, yearly, and with no major safety concerns(10,11). This drug has demonstrated in vitro efficacy against COVID 19 and there are clinical trials that have been initiated, to assess the efficacy in COVID 19. The drugs have been approved by LNJP institutional committee for use in all admitted COVID 19 patients, with precautions in specific groups. We are already using the drug, in admitted patients, in department of pediatrics (12). Given the fact that it is an easily and locally available, is a cheap drug, with a well-established safety profile, and has demonstrated in-vitro effects against COVID 19, we chose this drug for its potential against COVID 19.

For the purpose of this study, we intend to do a single centre, randomized controlled, open labelled trial, to assess, the efficacy of single dose ivermectin, given within first 72 hours, of symptom onset, as assessed by Reverse transcription polymerase chain reaction (RT-PCR) for severe acute respiratory syndrome coronavirus 2 (SARS CoV 2), at 3rd and 7th day of treatment. We also want to assess through the study, the safety profile of the drug, symptom resolution as assessed everyday till 7 days of admission. At Day 21, from the administration of drug. we intend to have a telephonic conversation to assess any residual symptoms. For the purpose of the study, we shall include patients, who satisfy the inclusion and exclusion criterion as detailed further in this document, then randomize them into either ivermectin or control group, before administering single dose of ivermectin. Through this study, the patient data generated, will be entered into a predesigned proforma, and patient confidentiality shall be strictly maintained.

Bibliography

1.         Chan JF-W, Yuan S, Kok K-H, To KK-W, Chu H, Yang J, et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. The Lancet. 2020 Feb 15;395(10223):514–23.

2.         Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. New England Journal of Medicine. 2020 Feb 20;382(8):727–33.

3.         Chu H, Chan JF-W, Yuen TT-T, Shuai H, Yuan S, Wang Y, et al. Comparative tropism, replication kinetics, and cell damage profiling of SARS-CoV-2 and SARS-CoV with implications for clinical manifestations, transmissibility, and laboratory studies of COVID-19: an observational study. The Lancet Microbe. 2020 May; 1(1):e14–23.

4.         Zhou P, Yang X-L, Wang X-G, Hu B, Zhang L, Zhang W, et al. A pneumonia outbreak associated with a new coronavirus of probable bat origin. Nature. 2020 Mar;579(7798):270–3.

5.         Choudhary R, Sharma AK. Potential use of hydroxychloroquine, ivermectin and azithromycin drugs in fighting COVID-19: trends, scope and relevance. New Microbes New Infect. 2020 May; 35:100684.

6.         Azeem S, Ashraf M, Rasheed MA, Anjum AA, Hameed R. Evaluation of cytotoxicity and antiviral activity of ivermectin against Newcastle disease virus. Pak J Pharm Sci. 2015 Mar;28(2):597–602.

7.         Mastrangelo E, Pezzullo M, De Burghgraeve T, Kaptein S, Pastorino B, Dallmeier K, et al. Ivermectin is a potent inhibitor of flavivirus replication specifically targeting NS3 helicase activity: new prospects for an old drug. J Antimicrob Chemother. 2012 Aug;67(8):1884–94.

8.         Götz V, Magar L, Dornfeld D, Giese S, Pohlmann A, Höper D, et al. Influenza A viruses escape from MxA restriction at the expense of efficient nuclear vRNP import. Sci Rep. 2016 Mar 18;6:23138.

9.         Lundberg L, Pinkham C, Baer A, Amaya M, Narayanan A, Wagstaff KM, et al. Nuclear import and export inhibitors alter capsid protein distribution in mammalian cells and reduce Venezuelan Equine Encephalitis Virus replication. Antiviral Res. 2013 Dec;100(3):662–72.

10.       Mectizan Donation Program Annual Highlights 2017 [Internet]. Available from: https://mectizan.org/wp-content/uploads/2018/06/MDP_AH17_English.pdf

11.       The Ivermectin Roadmappers  null. A Roadmap for the Development of Ivermectin as a Complementary Malaria Vector Control Tool. Am J Trop Med Hyg. 2020;102(2s):3–24.

12.       Daga MK, Jhamb U, Agarwal M, Garg S. Recommendations for use of various drugs in LNH vide MD LNH No. PS/MD/LNH/2020/273.Dated. 29.06.2020.  
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