Max Ivermectin- COVID 19 Study Versus Standard of Care Treatment for COVID 19 Cases. A Pilot Study

To Study the Effectiveness of Ivermectin With Standard of Care Treatment Versus Standard of Care Treatment for COVID 19 Cases. A Pilot Study

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 reported 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 about 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.

Study Overview

• Status: Unknown
• Conditions: COVID
• Intervention / Treatment: Drug: Ivermectin

Detailed Description

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 400 mcg 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.

1. Test for virus at 1, 3 & 5 days from beginning of trial drug started for the patient in the hospital
2. Clinical profile of the patient every day of hospitalization
3. Investigation of pulmonary function and oxygen saturation every day of hospitalization
4. The day a patient is put on ventilator and the day when removed
5. 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 enrollment, 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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110017
      • Recruiting
      • Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• Patients who are critically sick

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I- Ivermectin; 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	Drug: Ivermectin; Ivermectin 200 to 400 mcg per kg body weight
No Intervention: Group II- standard treatment; The second group with 25 confirmed cases of COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of Ivermectin on eradication of virus.	Test for virus at 1, 3 & 5 days from beginning of trial drug started for the patient in the hospital	3 months

Collaborators and Investigators

• Sponsor: Max Healthcare Insititute Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2020
• Primary Completion (Anticipated): July 25, 2020
• Study Completion (Anticipated): July 25, 2020

Study Registration Dates

• First Submitted: April 26, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: MHC-COVID-19- INV- ACT-BHR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No