Effectiveness of Ivermectin in SARS-CoV-2/COVID-19 Patients

NCT04739410 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: IRB#FMH-07-2020-IRB-766-M
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The first case of Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were diagnosed in Wuhan, China in 2019. In the first half of 2020 this disease has already converted into a global pandemic. Objectives: To assess the efficacy of Ivermectin in mild cases of COVID-19 patients on the basis of predefined assessment criteria. Study Settings: Fatima Memorial Hospital, Lahore Study Design: Open label randomized control trial. Duration of Study: From 1st May, 2020 to 30th June, 2020.Patients \& Methods: Sample size and technique: Sample size was 50 patients; 25 patients were kept in control group and 25 patients were kept in experimental group

Conditions

Covid19

Keywords

Corona virus; SARS-COv-2; Ivermectin; pandemic; antiviral

Outcome Measures

Primary Outcomes (2)

• Resolution of symptoms

  Will look for resolution of Fever, Fatigue, myalgias, cough and we had an questionaire for that as well and followed up on their chest x rays for progression of the disease

  7 days

• Progression of the disease

  did the disease progress from mild to moderate severity, like follow up chest x ray showed more infiltrates or their oxygen saturations in % dropped from their baseline and baseline symptoms persisted and got worse

  14 days

Study Arms (2)

Ivermectin

EXPERIMENTAL

Ivermectin Prescribing protocol: Participants were prescribed Ivermectin 12mg stat per oral and then 12 mg per oral after 12 hours and 12mg per oral after 24 hours and we looked at the response at day 7 on follow up in terms of improvement of symptoms like (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue. and any side effects of the drugs were noted as well.

Drug: Ivermectin

SOC standard of care

PLACEBO COMPARATOR

These participants were given standard of care without Ivermectin standard of care only symptomatic treatment

Drug: Ivermectin

Interventions

Ivermectin DRUG

Ivermectin Prescribing protocol: Participants were prescribed Ivermectin 12 mg per oral stat and then 12 mg per oral after 12 hours and 12 mg per oral after 24 hours and we looked at the response at day 7 on follow up in terms of improvement of symptoms like (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue.Any side effects of the drugs were noted as well

Also known as: Experimental

Ivermectin; SOC standard of care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients diagnosed with COVID-19 infection with positive reverse transcriptase RT-PCR test, who were willing to participate in this study
• Patients having age of 18-75 years
• Patients of both genders male and female
• Patients who had mild symptoms of Corona virus disease and RT- PCR positive for SARS-Cov-2
• Ability to take oral medication and were willing to adhere to the drug intake regimen

You may not qualify if:

• Known severe allergic reactions to Ivermectin
• Pregnancy or breastfeeding
• Severe symptoms likely attributed to Cytokine Release Storm
• Malignant diseases
• Chronic kidney disease
• Cirrhosis liver with Child class B or C

Sponsors & Collaborators

• FMH College of Medicine and Dentistry: lead

Study Sites (1)

Aijaz Zeeshan Khan Chachar

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Aijaz Zeeshan Khan Chachar, MBBS,FCPS

  FMH College of Medicine & Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician (Senior Registrar)

Model Details: Response of the patients after Ivermectin prescription and response of the patients without Ivermectin prescription was recorded. Response was recorded on the basis of clinical parameters (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue. Any side effects noted after prescription of Ivermectin was recorded.

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 4, 2021
• Study Start: May 1, 2020
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: as soon as i will have time to respond

Locations

PA (1)