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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2020
CompletedFirst Submitted
Initial submission to the registry
April 26, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2020
CompletedMay 4, 2020
May 1, 2020
3 months
April 26, 2020
May 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Group I- Ivermectin
EXPERIMENTALFirst 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 INTERVENTIONThe second group with 25 confirmed cases of COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects within age group between 18 to 75 years
- With either sex, male or female
- Confirmed case of COVID-19 at Max Hospitals.
You may not qualify if:
- Patients who are critically sick
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)
New Delhi, National Capital Territory of Delhi, 110017, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandeep Budhiraja, MRCP, FACP
Max Healthcare
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2020
First Posted
May 4, 2020
Study Start
April 25, 2020
Primary Completion
July 25, 2020
Study Completion
July 25, 2020
Last Updated
May 4, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share