Efficacy of Ivermectin in COVID-19
1 other identifier
interventional
100
1 country
1
Brief Summary
It is a randomized controlled trial to assess the efficacy of Ivermectin in COVID-19. Patient recruited will be assigned to two groups one group will be given ivermectin with standard chloroquine regimen and the other group will be receiving chloroquine only. Out come will be recorded by documenting PCR reports at 48, 96 and 144 hours.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2020
CompletedFirst Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedMay 19, 2020
May 1, 2020
3 months
May 5, 2020
May 17, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Negative PCR
PCR will be done at 48, 96 and 144 hours
144 hours
Secondary Outcomes (1)
Need for mechanical ventilation
4 weeks
Study Arms (2)
Ivermectin arm
ACTIVE COMPARATORParticipants will be administered Ivermectin with standard chloroquine regimen
Control arm
NO INTERVENTIONThis arm will only receive chloroquine as per existing policy of hospital
Interventions
12 mg single dose of Ivermectin will be given to intervention arm
Eligibility Criteria
You may qualify if:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 15 to 65 years
- In good general health with no or mild to moderate symptoms of Corona virus disease
- PCR positive for SARS-Cov-2.
- Ability to take oral medication and be willing to adhere to the drug intake regimen
You may not qualify if:
- Severe symptoms likely attributed to Cytokine Release Storm.
- Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Combined Military Hospital Lahore
Lahore, Punjab Province, Pakistan
Related Publications (2)
Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.
PMID: 32251768BACKGROUNDSimsek Yavuz S, Unal S. Antiviral treatment of COVID-19. Turk J Med Sci. 2020 Apr 21;50(SI-1):611-619. doi: 10.3906/sag-2004-145.
PMID: 32293834RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karamat Hu Bukhari, FCPS MED
Combined military hospital lahore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Medicine
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 19, 2020
Study Start
April 15, 2020
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
May 19, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share