Max Ivermectin- COVID 19 Study Versus Standard of Care Treatment for COVID 19 Cases. A Pilot Study
NCT ID: NCT04373824
Last Updated: 2020-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-04-25
2020-07-25
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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
Ivermectin
Ivermectin 200 to 400 mcg per kg body weight
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.
No interventions assigned to this group
Interventions
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Ivermectin
Ivermectin 200 to 400 mcg per kg body weight
Eligibility Criteria
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Inclusion Criteria
2. With either sex, male or female
3. Confirmed case of COVID-19 at Max Hospitals.
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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Max Healthcare Insititute Limited
OTHER
Responsible Party
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Principal Investigators
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Sandeep Budhiraja, MRCP, FACP
Role: PRINCIPAL_INVESTIGATOR
Max Healthcare
Locations
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Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MHC-COVID-19- INV- ACT-BHR
Identifier Type: -
Identifier Source: org_study_id
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