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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04373824
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Max Healthcare Insititute Limited

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 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 25 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 : April 25, 2020
Estimated Primary Completion Date : July 25, 2020
Estimated Study Completion Date : July 25, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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.



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373824


Contacts
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Contact: Sandeep Budhiraja, MRCP, FACP 9810262954 sbudhiraja@maxhealthcare.com
Contact: Ram Shankar Mishra, DNB, FRCP 9810193145 docmishra@yahoo.co.in

Locations
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India
Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation) Recruiting
New Delhi, Delhi, India, 110017
Contact: Rajesh Saxena, MBA    9818474003    rajesh.saxena@maxhealthcare.com   
Principal Investigator: Sandeep Budhiraja, MRCP, FACP         
Sub-Investigator: Ram Shankar Mishra, DNB, FRCP         
Sponsors and Collaborators
Max Healthcare Insititute Limited
Investigators
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Principal Investigator: Sandeep Budhiraja, MRCP, FACP Max Healthcare
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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    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Ivermectin
Antiparasitic Agents
Anti-Infective Agents