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Efficacy of Ivermectin in COVID-19

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: NCT04392713
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Asma Asghar, Combined Military Hospital, Pakistan

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.

Condition or disease Intervention/treatment Phase
COVID Drug: Ivermectin 6 MG Oral Tablet (2 tablets) Not Applicable

Detailed Description:

INTERVENTION It will be a randomized controlled trial which will be done on COVID-19 patients proven by PCR fulfilling the criteria (asymptomatic/mild to moderate severity). They will be divided into two groups after randomization. Group A will be administered Ivermectin single dose of 12grams along with Chloroquine as per existing hospital guidelines and group B will be given Chloroquine alone. Dose of Ivermectin to be repeated at 1 week if PCR stays negative. PCR will be done on alternate days (48, 96 and 144hours) and the duration at which the PCR becomes negative will be compared. Dose of drug subject to change in accordance with patient response or possible side effect.

ELIGIBILITY CRITERIA INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

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 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 EXCLUSION CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

Severe symptoms likely attributed to Cytokine Release Storm. Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Ivermectin in COVID-19 : A Randomized Controlled Trial
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arm Intervention/treatment
Active Comparator: Ivermectin arm
Participants will be administered Ivermectin with standard chloroquine regimen
Drug: Ivermectin 6 MG Oral Tablet (2 tablets)
12 mg single dose of Ivermectin will be given to intervention arm

No Intervention: Control arm
This arm will only receive chloroquine as per existing policy of hospital



Primary Outcome Measures :
  1. Negative PCR [ Time Frame: 144 hours ]
    PCR will be done at 48, 96 and 144 hours


Secondary Outcome Measures :
  1. Need for mechanical ventilation [ Time Frame: 4 weeks ]
    All patients will be assessed for requirement of mechanical ventilation in both the groups



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:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Severe symptoms likely attributed to Cytokine Release Storm.
  • Malignant diseases, diabetes mellitus, chronic kidney disease and cirrhosis liver with CPT class B or C.

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): NCT04392713


Contacts
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Contact: Asma Asghar, FCPS MED 00923225141033 Asghar.asma79@gmail.com
Contact: Najma Parveen, FCPS med 00 92 322 5335786

Locations
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Pakistan
Combined Military Hospital Lahore Recruiting
Lahore, Punjab, Pakistan
Contact: Najma Parveen, FCPS MED    00923225335786    Najma.med@gmail.com   
Sponsors and Collaborators
Combined Military Hospital, Pakistan
Investigators
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Study Director: Karamat Hu Bukhari, FCPS MED Combined Military Hospital Lahore
Publications of Results:
Other Publications:
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Responsible Party: Asma Asghar, Consultant Medicine, Combined Military Hospital, Pakistan
ClinicalTrials.gov Identifier: NCT04392713    
Other Study ID Numbers: IVE-COV
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 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