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

• Sponsor: Max Healthcare Insititute Limited (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04373824
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID	Drug: Ivermectin	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: 25 subjects in each Arm25 subjects in each Arm
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: To Study the Effectiveness of Ivermectin With Standard of Care Treatment Versus Standard of Care Treatment for COVID 19 Cases. A Pilot Study
• Actual Study Start Date: Apr 25, 2020
• Anticipated Primary Completion Date: Jul 25, 2020
• Anticipated Study Completion Date: Jul 25, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. effect of Ivermectin on eradication of virus. [3 months]

   Test for virus at 1, 3 & 5 days from beginning of trial drug started for the patient in the hospital

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)	New Delhi	Delhi	India	110017

Sponsors and Collaborators

• Max Healthcare Insititute Limited

Investigators

• Principal Investigator: Sandeep Budhiraja, MRCP, FACP, Max Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Max Healthcare Insititute Limited
• ClinicalTrials.gov Identifier: NCT04373824
• Other Study ID Numbers: MHC-COVID-19- INV- ACT-BHR
• First Posted: May 4, 2020
• Last Update Posted: May 4, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: COVID-19; Ivermectin

Study Results

No Results Posted as of May 4, 2020