Efficacy of Ivermectin in COVID-19

Efficacy of Ivermectin in COVID-19 : A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: COVID
• Intervention / Treatment: Drug: Ivermectin 6 MG Oral Tablet (2 tablets)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asma Asghar, FCPS MED; Phone Number: 00923225141033; Email: Asghar.asma79@gmail.com
• Study Contact Backup: Name: Najma Parveen, FCPS med; Phone Number: 00 92 322 5335786

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Recruiting
      • Combined Military Hospital Lahore
      • Contact: Najma Parveen, FCPS MED; Phone Number: 00923225335786; Email: Najma.med@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 63 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative PCR	PCR will be done at 48, 96 and 144 hours	144 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for mechanical ventilation	All patients will be assessed for requirement of mechanical ventilation in both the groups	4 weeks

Collaborators and Investigators

• Sponsor: Combined Military Hospital, Pakistan
• Investigators: Study Director: Karamat Hu Bukhari, FCPS MED, Combined Military Hospital Lahore

Publications and helpful links

General Publications

• 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.
• Simsek 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 17, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 17, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: IVE-COV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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