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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I- Ivermectin | Experimental | 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 |
|
| Group II- standard treatment | No Intervention | The second group with 25 confirmed cases of COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivermectin | Drug | Ivermectin 200 to 400 mcg per kg body weight |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandeep Budhiraja, MRCP, FACP | Contact | 9810262954 | sbudhiraja@maxhealthcare.com | |
| Ram Shankar Mishra, DNB, FRCP | Contact | 9810193145 | docmishra@yahoo.co.in |
| Name | Affiliation | Role |
|---|---|---|
| Sandeep Budhiraja, MRCP, FACP | Max Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation) | Recruiting | New Delhi | National Capital Territory of Delhi | 110017 | India |
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| ID | Term |
|---|---|
| D007559 | Ivermectin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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25 subjects in each Arm
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