Efficacy of Ivermectin in COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-15

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19

NCT04429711

COVID-19

UNKNOWN NA

New Antiviral Drugs for Treatment of COVID-19

NCT04392427

COVID Drug Effect

UNKNOWN PHASE3

Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms

NCT04407507

COVID-19

COMPLETED PHASE2

Ivermectin Treatment Efficacy in Covid-19 High Risk Patients

NCT04920942

COVID-19

COMPLETED PHASE3

Ivermectin In Treatment of COVID 19 Patients

NCT04425707

Covid19

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ivermectin arm

Participants will be administered Ivermectin with standard chloroquine regimen

Group Type ACTIVE_COMPARATOR

Ivermectin 6 MG Oral Tablet (2 tablets)

Intervention Type DRUG

12 mg single dose of Ivermectin will be given to intervention arm

Control arm

This arm will only receive chloroquine as per existing policy of hospital

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ivermectin 6 MG Oral Tablet (2 tablets)

12 mg single dose of Ivermectin will be given to intervention arm

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No