“To study the effectiveness of Ivermectin with standard of care treatmentversus standard of care treatment for COVID 19 cases. A Pilot Study

Not yet recruiting

• Conditions: Other specified viral diseases,

• Registration Number: CTRI/2020/04/024858
• Lead Sponsor: Max Super Speciality Hospital A Unit of Devki Devi Foundation

Brief Summary

Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The diseasecauses respiratory illness (like the flu) with symptoms such as a cough, fever, and in moresevere 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 previouslyshown 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 studyrationale 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 19then 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 tovoluntarily participate into the study by signing and dating the informed consent form beforestarting any trial related treatment. 50 cases of COVID-19 will be enrolled into the trial. The trialshall be divided into two groups. First group with 25 confirmed cases of COVID 19 shall betreated with Ivermectin 200 to 400mcg per kg body weight on day 1 and day 2 along withstandard treatment of the hospital protocol. The second group with 25 confirmed cases ofCOVID 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 asper below schedule.



ï‚· Test for virus at 1, 3 & 5 days from beginning of trial drug started for the patient in thehospital

ï‚· Clinical profile of the patient every day of hospitalization

ï‚· Investigation of pulmonary function and O2 saturation every day of hospitalization

ï‚· The day a patient is put on ventilator and the day when removed

ï‚· The day a patient develops acute respiratory distress syndrome and the day whenrelieved



All the above data shall be collected on paper case record form for interim and final analysisfrom 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 ofenrollment and providing the study drug on daily basis upto eradication of virus or completion ofthe trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-25
• Last Update Posted: 2020-04-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

Patients who are critically sick.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study aims to confirm the antivirus effectiveness of Ivermectin on coronavirus i.e COVID 19	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
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 Measures

Name	Time	Method
Safety of the drug vs standard care of treatment will be checked	Treatment will be provided until the eradication of virus or completion of

Trial Locations

Locations (1)

Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation); 🇮🇳 Delhi, DELHI, India

Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)

🇮🇳Delhi, DELHI, India

Dr Sandeep Budhiraja

Principal investigator

9810262954

sbudhiraja@maxhealthcare.com