Go here to refresh this list.

Search for "ivermectin", scroll down to where the covid19 trials start, check the View checkboxes on the right, and click [View Selected Trials]

IVERTODO: Write up these trials!

Links to the collection of trials don't work (the page never returns from the server) so I posted the 5 trials to separate posts.

They are a lot easier to read if you use the "refresh" link above, search for ivermectin, then scroll down to the studies dated after the pandemic's start. The earliest is 25/04/2020 (the date format used on the site so you can search for it).

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CTRI Number CTRI/2020/04/024858 [Registered on: 25/04/2020] Trial Registered Prospectively Last Modified On: 25/04/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Non-randomized, Active Controlled Trial Public Title of Study “To study the effectiveness of Ivermectin with standard of care treatment versus standard of care treatment for COVID 19 cases. A Pilot Study Scientific Title of Study “To study the effectiveness of Ivermectin with standard of care treatment versus standard of care treatment for COVID 19 cases. A Pilot Study Secondary IDs if Any
Secondary ID Registry NIL NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name Dr Sandeep Budhiraja Address Max Super Speciality Hospital (DDF), East Block, Internal Medicine department, 2- Press Enclave Road, New Delhi

New Delhi DELHI 110017 India Phone
Fax
Email sbudhiraja@maxhealthcare.com

Details Contact Person Scientific Query Modification(s)
Name Dr Ram Shankar Mishra Address Max Super Speciality Hospital (DDF), East Block, Internal Medicine Department, 2- Press Enclave Road, New Delhi

New Delhi DELHI 110017 India Phone 9810193145
Fax
Email docmishra@yahoo.co.in

Details Contact Person Public Query Modification(s)
Name Rajesh Saxena Address Max Super Speciality Hospital (DDF), East Block, Service Floor, 2- Press Enclave Road, New Delhi

New Delhi DELHI 110017 India Phone 9818474003
Fax
Email rajesh.saxena@maxhealthcare.com

Source of Monetary or Material Support Modification(s)
Max Super Speciality Hospital (DDF) Saket

Primary Sponsor
Name Max Super Speciality Hospital A Unit of Devki Devi Foundation Address 2, Press Enclave Road, Saket, New Delhi-17 Type of Sponsor Private hospital/clinic

Details of Secondary Sponsor
Name Address NIL NIL

Countries of Recruitment India
Sites of Study Modification(s)
No of Sites = 1
Contact Person Name of Site Site Address Phone/Fax/Email Dr Sandeep Budhiraja Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation) Department of Internal Medicine, 2, Press Enclave Road, Saket, New Delhi-17 New Delhi 9810262954

sbudhiraja@maxhealthcare.com

Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee Approval Status Institutional Ethics Committee Approved

Regulatory Clearance Status from DCGI Modification(s)
Status Not Applicable

Health Condition / Problems Studied
Health Type Condition Patients Other specified viral diseases

Intervention / Comparator Agent Modification(s)
Type Name Details Intervention Ivermectin Cases of COVID 19 shall be treated with Ivermectin 200 to 400mcg per kg body weight on day 1 and day 2 along with standard treatment of the hospital protocol Comparator Agent Standard treatment as per hospital protocol for COVID 19 Cases of COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19 until the recovery.

Inclusion Criteria
Age From 18.00 Year(s) Age To 75.00 Year(s) Gender Both Details 1. Subjects within age group between 18 to 75 years 2. With either sex, male or female 3. Confirmed case of COVID-19 at Max Hospitals.

ExclusionCriteria
Details Patients who are critically sick

Method of Generating Random Sequence Not Applicable Method of Concealment
Blinding/Masking Open Label Primary Outcome Modification(s)
Outcome TimePoints This study aims to confirm the antivirus effectiveness of Ivermectin on coronavirus i.e COVID 19 then to explore its potential use in the combating to the COVID 19 pandemics. Viral load will be monitored at 1, 3 & 5 days from beginning of trial drug (48 hours interval) Until the report comes negative. Drug will be delivered on daily basis upto eradication of virus or completion of the trial

Secondary Outcome Modification(s)
Outcome TimePoints Safety of the drug vs standard care of treatment will be checked Treatment will be provided until the eradication of virus or completion of the trial.

Target Sample Size Total Sample Size="50" Sample Size from India="50" Phase of Trial N/A Date of First Enrollment (India) Modification(s) 25/04/2020 Date of First Enrollment (Global) No Date Specified Estimated Duration of Trial Years="1" Months="0" Days="0" Recruitment Status of Trial (Global) Modification(s) Not Applicable Recruitment Status of Trial (India) Not Yet Recruiting Publication Details
Brief Summary Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The disease causes respiratory illness (like the flu) with symptoms such as a cough, fever, and in more severe cases, difficulty breathing. At present, there are no specific treatments for COVID-19. WHO recommends four treatments for COVID 19 with drugs i.eRemdesivir, Lopinavir/ ritonavir, Lopinavir/ ritonavir with interferon beta -1a, and chloroquine or hydroxychloroquine. Currently, there are several ongoing clinical trials evaluating potential treatments. Recently, LeonCaly report here that Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post infection with SARSCoV-2 able to effect ∼5000-fold reduction in viral RNA at 48 h. Ivermectin therefore warrant further investigation for possible benefits in humans. The study rationale is to understand the effect of the drug on eradication of virus. This study aims to confirm the antivirus effectiveness of Ivermectin on coronavirus i.e COVID 19 then to explore its potential use in the combating to the COVID 19 pandemics.

Enrollment of subject into the trial shall only occur after providing written permission to voluntarily participate into the study by signing and dating the informed consent form before starting any trial related treatment. 50 cases of COVID-19 will be enrolled into the trial. The trial shall be divided into two groups. First group with 25 confirmed cases of COVID 19 shall be treated with Ivermectin 200 to 400mcg per kg body weight on day 1 and day 2 along with standard treatment of the hospital protocol. The second group with 25 confirmed cases of COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19. Subjects in both the arms shall be followed up for recovery of death with regular monitoring as per below schedule.

 Test for virus at 1, 3 & 5 days from beginning of trial drug started for the patient in the hospital  Clinical profile of the patient every day of hospitalization  Investigation of pulmonary function and O2 saturation every day of hospitalization  The day a patient is put on ventilator and the day when removed  The day a patient develops acute respiratory distress syndrome and the day when relieved

All the above data shall be collected on paper case record form for interim and final analysis from start of the trial i.e enrolment, treatment and follow-up. Viral test to monitor the eradication of Virus shall be done free of cost from third day of enrollment and providing the study drug on daily basis upto eradication of virus or completion of the trial.

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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 Secondary IDs if Any
Secondary ID Registry NIL NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name Anupam Prakash 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 Contact Person Scientific Query
Name Anupam Prakash 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 Contact Person Public Query
Name Anupam Prakash 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 Modification(s)
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 Modification(s)
No of Sites = 1
Contact Person 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 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 Modification(s)
Health Type Condition Patients Coronavirus as the cause of diseases classified elsewhere Patients 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" Phase of Trial Phase 2 Date of First Enrollment (India) 15/05/2020 Date of First Enrollment (Global) No Date Specified Estimated Duration of Trial Years="0" Months="6" Days="0" Recruitment Status of Trial (Global) Modification(s) 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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CTRI Number CTRI/2020/05/025068 [Registered on: 07/05/2020] Trial Registered Prospectively Last Modified On: 07/05/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Can a medicine help in curing viral infection Scientific Title of Study A Phase IIB open label randomized controlled trial to evaluate the efficacy and safety of Ivermectin in reducing viral loads in patients with hematological disorders who are admitted with COVID 19 infection Secondary IDs if Any Modification(s)
Secondary ID Registry Not applicable NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name Biju George Address Department of Haematology, First Floor, Room no-3, Christian Medical College

Vellore TAMIL NADU 632004 India Phone 04162282352
Fax 04162226449
Email biju@cmcvellore.ac.in

Details Contact Person Scientific Query
Name Biju George Address Department of Haematology, First Floor, Room no-3, Christian Medical College Department of Haematology, First Floor, Room no-3, Christian Medical College

TAMIL NADU 632004 India Phone 04162282352
Fax 04162226449
Email biju@cmcvellore.ac.in

Details Contact Person Public Query
Name Biju George Address Department of Haematology, First Floor, Room no-3, Christian Medical College Department of Haematology, First Floor, Room no-3, Christian Medical College

TAMIL NADU 632004 India Phone 04162282352
Fax 04162226449
Email biju@cmcvellore.ac.in

Source of Monetary or Material Support Modification(s)
Christian Medical College Vellore, Ida Scudder Road, Vellore, 632004, Tamil Nadu

Primary Sponsor
Name Christian Medical College Vellore Address Christian Medical College, Vellore, 632004, Tamil Nadu, India Type of Sponsor Other [Charitable trust hospital]

Details of Secondary Sponsor
Name Address cience and Engineering Research Board SERB 5 & 5A, Lower Ground Floor Vasant Square Mall Sector-B, Pocket-5 Vasant Kunj New Delhi – 110 070

Countries of Recruitment India
Sites of Study
No of Sites = 1
Contact Person Name of Site Site Address Phone/Fax/Email Biju George Christian Medical College Vellore Department of Haematology, Christian Medical College, Vellore, 632004 Vellore 04162282352 04162226449 biju@cmcvellore.ac.in

Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee Approval Status Ethics Committee - Institution Review Board Approved

Regulatory Clearance Status from DCGI
Status Not Applicable

Health Condition / Problems Studied
Health Type Condition Patients Other specified viral diseases

Intervention / Comparator Agent Modification(s)
Type Name Details Intervention Ivermectin The doses are as follows (based on body weight) 15 - 24 kg: 3 mg PO once 25 - 35 kg: 6 mg PO once 36 - 50 kg: 9 mg PO once 51 - 65 kg: 12 mg PO once 66 - 79 kg: 15 mg PO once 80 kg and 15 kg: 200 ug/kg PO once Comparator Agent patients will receive the standard protocol for management of COVID 19 infection. patients will receive the standard protocol for management of COVID 19 infection.

Inclusion Criteria
Age From 1.00 Year(s) Age To 65.00 Year(s) Gender Both Details Confirmed diagnosis of COVID19 infection based on +ve RTPCR

ExclusionCriteria
Details Patients with other viral infections

Method of Generating Random Sequence Computer generated randomization Method of Concealment Not Applicable Blinding/Masking Open Label Primary Outcome
Outcome TimePoints To study if Ivermectin can reduce the viral load in patients with hematological illnesses who are admitted with COVD19 infection Day 7

Secondary Outcome
Outcome TimePoints To study the factors that affect viral load reduction To study if the reduction in viral load correlates with improvement in inflammatory parameters To study the incidence of serious adverse events and safety of this drug when used in hematological illnesses Day 7 Day 20

Target Sample Size Total Sample Size="50" Sample Size from India="50" Phase of Trial Phase 3 Date of First Enrollment (India) Modification(s) 27/05/2020 Date of First Enrollment (Global) No Date Specified Estimated Duration of Trial Years="1" Months="0" Days="0" Recruitment Status of Trial (Global) Not Applicable Recruitment Status of Trial (India) Not Yet Recruiting Publication Details We will plan to publish the results of this study in reputed National and International Journals. Brief Summary
Corona virus disease 2019, a recently declared pandemic by the World Health Organization, is associated with a mortality ranging from 1-5% in immunocompetent individuals and will probably results in higher mortality in immunosuppressed patients. One of the important factors affecting outcomes including morality and ICU admission has been the viral load at the onset of disease and the rate of viral clearance. There are no standard drugs that are of proven benefit against the COVID 19 virus and majority of the treatment has been supportive. Recent data has suggested that ivermectin, an antiparasitic drug, is able to cause a 5000 fold reduction in viral RNA at 48 hours post exposure in cell lines. Ivermectin is a very safe drug to use in immunosuppressed patients for treatment of parasitic infections and has a good safety and tolerability profile.

In this study, we would like to randomize patients into 2 groups – group A will get the standard treatment protocol for COVID 19 infection as per institutional protocols and Group B will receive the standard treatment along with Ivermectin given on day 1 and Day 8. Baseline samples will be collected to look for presence of cytopenia, coagulopathy and also status of the immune system. The PCR samples will be stored for quantification of the viral load at a later point of time. PCR samples will be repeated on alternate days starting on Day 1 followed by 3, 5, 7, 10 and 14 and then at weekly intervals till discharge/death. All patients will be followed till recovery from illness or death. Blood parameters that are abnormal will be repeated twice a week till discharge. We will study whether there is a rapid clearance of the virus with the use of ivermectin and whether that has led to better outcomes.

Results and Conclusion:

We will be able to study if ivermectin reduces the viral load and whether this reduction will lead to stabilization of disease and clinical findings including the inflammatory parameters.

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CTRI Number CTRI/2020/05/025224 [Registered on: 18/05/2020] Trial Registered Prospectively Last Modified On: 16/05/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Drug Study Design Randomized, Parallel Group Trial Public Title of Study Study to efficacy of Ivermectin in patients of COVID-19 Scientific Title of Study Interventional study to assess the efficacy of Ivermectin with standard of care treatment versus standard of care in patients of COVID-19 at R D Gardi Medical College, Ujjain, India Secondary IDs if Any
Secondary ID Registry NIL NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name Dr Sunil Rathi
Address 3rd Floor, Department of Pediatrics R D Gardi Medical College Agar Road, Surasa Ujjain MADHYA PRADESH 456006 India Phone 9425093116
Fax
Email sunil.k.rathi.59@gmail.com

Details Contact Person Scientific Query Modification(s)
Name Dr Ashish Pathak
Address 3rd Floor, Department of Pediatrics C R Gardi Hospital R D Gardi Medical College Agar Road, Surasa Ujjain MADHYA PRADESH 456006 India Phone 9302239899
Fax
Email drashish.jpathak@gmail.com

Details Contact Person Public Query Modification(s)
Name Dr Ashish Pathak
Address 3rd Floor, Department of Pediatrics C R Gardi Hospital R D Gardi Medical College Agar Road, Surasa Ujjain MADHYA PRADESH 456006 India Phone 9302239899
Fax
Email drashish.jpathak@gmail.com

Source of Monetary or Material Support
R D Gardi Medical College Agar Road, Surasa, Ujjain Madhya Pradesh 456006 India

Primary Sponsor
Name R D Gardi Medical College Address Agar Road, Surasa, Ujjain Madhya Pradesh 456006 India Type of Sponsor Private medical college

Details of Secondary Sponsor
Name Address NIL NIL

Countries of Recruitment India
Sites of Study
No of Sites = 1
Contact Person Name of Site Site Address Phone/Fax/Email Dr Ashish Pathak R D Gardi Medical College, Ujjain 3rd Floor, Department of Pediatrics C R Gardi Hospital R D Gardi medical College Ujjain 9302239899

drashish.jpathak@gmail.com

Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee Approval Status Institutional Ethics Committee, R D Gardi Medical College, Ujjain Approved

Regulatory Clearance Status from DCGI
Status Not Applicable

Health Condition / Problems Studied
Health Type Condition Patients Coronavirus as the cause of diseases classified elsewhere

Intervention / Comparator Agent Modification(s)
Type Name Details Intervention Ivermectin Ivermectin 12mg OD at night Route of administration- Oral Duration of therapy - 2 days with standard of care as per hospital guidelines
Comparator Agent Standard of care Standard of care as per hospital guidelines.

Inclusion Criteria Modification(s)
Age From 18.00 Year(s) Age To 75.00 Year(s) Gender Both Details 1. Adults (age ≥18 years to ≤75 years) 2. Laboratory-confirmed SARS-CoV-2 infection and, in the view of the responsible doctor, no contra-indication to any of the study treatments 3. Hospitalized at R D Gardi Medical College, Ujjain Madhya Pradesh

ExclusionCriteria
Details 1. Anticipated transfer to another hospital, within 72 hours, which is not a study site 2. Known allergy to study medication or its components (non-medicinal ingredients) 3. Known HIV infection

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 Effect of Ivermectin on eradication of virus. Test for virus at 1, 3 and 5 days from beginning of trial drug started for the patient in the hospital 3 months

Secondary Outcome
Outcome TimePoints 1. Overall safety of the study drug 2. Duration of hospitalization 3. Improvement in the abnormal laboratory values 3 months

Target Sample Size Total Sample Size="50" Sample Size from India="50" Phase of Trial Phase 2 Date of First Enrollment (India) 24/05/2020 Date of First Enrollment (Global) No Date Specified Estimated Duration of Trial Years="0" Months="6" Days="0" Recruitment Status of Trial (Global) Modification(s) Not Applicable Recruitment Status of Trial (India) Not Yet Recruiting Publication Details Results will be published in relevant open access peer-reviewed scientific journals. Brief Summary
The aim of this study is to validate the antivirus effectiveness of Ivermectin on coronavirus i.e COVID 19 and study its effectiveness in combating COVID 19 pandemics.

At present, there are no specific treatments for COVID-19. Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post infection with SARSCoV-2 able to affect about 5000-fold reduction in viral RNA at 48 h. Ivermectin is a CDSCO approved drug. However, it requires further investigation for possible benefits COVID-19 patients and further eradication of COVID-19 virus.

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CTRI Number CTRI/2020/05/025333 [Registered on: 24/05/2020] Trial Registered Prospectively Last Modified On: 22/05/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Preventive Study Design Randomized, Parallel Group Trial Public Title of Study Study to assess efficacy of Ivermectin as prophylaxis of COVID -19 Scientific Title of Study Study to assess the efficacy of Ivermectin as prophylaxis of COVID 19 among health care workers and COVID 19 contacts in Ujjain, India Secondary IDs if Any
Secondary ID Registry NIL NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name Dr Sunil Rathi
Address 3rd Floor, Department of Pediatrics C R Gardi Hospital R D Gardi Medical College Agar Road, Surasa

Ujjain MADHYA PRADESH 456006 India Phone 9425093116
Fax
Email sunil.k.rathi.59@gmail.com

Details Contact Person Scientific Query
Name Dr Ashish Pathak Address 3rd Floor, Department of Pediatrics C R Gardi Hospital R D Gardi Medical College Agar Road, Surasa

Ujjain MADHYA PRADESH 456006 India Phone 9302239899
Fax
Email drashish.jpathak@gmail.com

Details Contact Person Public Query
Name Dr Ashish Pathak Address 3rd Floor, Department of Pediatrics C R Gardi Hospital R D Gardi Medical College Agar Road, Surasa

MADHYA PRADESH 456006 India Phone 9302239899
Fax
Email drashish.jpathak@gmail.com

Source of Monetary or Material Support Modification(s)
R D Gardi Medical College Agar Road, Surasa Ujjain Madhya Pradesh 456006

Primary Sponsor
Name R D Gardi Medical College Address R D Gardi Medical College Agar Road, Surasa Ujjain Madhya Pradesh Type of Sponsor Private medical college

Details of Secondary Sponsor
Name Address NIL NIL

Countries of Recruitment India
Sites of Study
No of Sites = 1
Contact Person Name of Site Site Address Phone/Fax/Email Dr Ashish Pathak R D Gardi Medical College, Ujjain 3rd Floor, Department of Pediatrics C R Gardi Hospital R D Gardi Medical College Agar Road, Surasa Ujjain 9302239899

drashish.jpathak@gmail.com

Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee Approval Status Institutional Ethics Committee, R D Gardi Medical College, Ujjain Approved

Regulatory Clearance Status from DCGI
Status Not Applicable

Health Condition / Problems Studied
Health Type Condition Healthy Human Volunteers Healthy health care workers or Healthy contact of COVID 19

Intervention / Comparator Agent
Type Name Details Comparator Agent Control- No intervention Control- No intervention Intervention Ivermectin Ivermectin 12 mg OD, oral, for 2 days in adults and 6 mg OD oral, for 2 days in children.

Inclusion Criteria Modification(s)
Age From 6.00 Year(s) Age To 75.00 Year(s) Gender Both Details Following are eligible to participate after giving written consent/assent - 1. Healthy health care workers 2. Contact of COVID 19

ExclusionCriteria
Details 1. Un healthy 2. Known allergy to study medication or its components (non-medicinal ingredients) 3. Known HIV infection

Method of Generating Random Sequence Computer generated randomization Method of Concealment An Open list of random numbers Blinding/Masking Open Label Primary Outcome Modification(s)
Outcome TimePoints Effect of Ivermectin as prophylaxis of virus

Outcome indicators are : 1. Resolution of sign and symptoms of COVID 19 2. Negative RTPCR done 48 hours after Ivermectin dose OR Change /reduction in CT value as reported in RTPCR for SARS-COV-2 virus assay. Change /reduction in CT value as reported in RTPCR after 48 hours of administration drug.

Secondary Outcome Modification(s)
Outcome TimePoints Overall safety of the study drug

The drug is safe in general. However, safety would be monitored by charting adverse events after administration of the drug for 7 days. This will be part of case report form. Secondary outcome indicators: No adverse event after administration of the drug. Adverse events will be systematically recorded and notified to institutional ethics committee Lab values : CT value of RTPCR as reported in primary outcome. 7 Days

Target Sample Size Total Sample Size="2000" Sample Size from India="2000" Phase of Trial Phase 2 Date of First Enrollment (India) 27/05/2020 Date of First Enrollment (Global) No Date Specified Estimated Duration of Trial Years="0" Months="6" Days="0" Recruitment Status of Trial (Global) Modification(s) Not Applicable Recruitment Status of Trial (India) Not Yet Recruiting Publication Details Results will be published in relevant open access peer-reviewed scientific journals. Brief Summary
This aims of this study is to validate the antivirus effectiveness of Ivermectin as prophylaxis in combating COVID 19 pandemics.

At present, there are no specific treatments for COVID-19. Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post infection with SARSCoV-2 able to affect about 5000-fold reduction in viral RNA at 48 h. Ivermectin is a CDSCO approved drug.

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