Efficacy of Ivermectin in COVID-19

Not Applicable

• Conditions: COVID
• Interventions: Drug: Ivermectin 6 MG Oral Tablet (2 tablets)

• Registration Number: NCT04392713
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2020-04-15
• Status Verified: 2020-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-17
• Last Update Submitted: 2020-05-17
• Study First Posted: 2020-05-19
• Last Update Posted: 2020-05-19
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivermectin arm	Ivermectin 6 MG Oral Tablet (2 tablets)	Participants will be administered Ivermectin with standard chloroquine regimen

Primary Outcome Measures

Name	Time	Method
Negative PCR	144 hours	PCR will be done at 48, 96 and 144 hours

Secondary Outcome Measures

Name	Time	Method
Need for mechanical ventilation	4 weeks	All patients will be assessed for requirement of mechanical ventilation in both the groups

Trial Locations

Locations (1)

Combined Military Hospital Lahore; 🇵🇰 Lahore, Punjab, Pakistan