Efficacy and Safety of Ivermectin and Doxycycline in Combination or IVE Alone in Patients With COVID-19 Infection.

NCT ID: NCT04407130

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-16
• Study Completion Date: 2020-11-20

Brief Summary

Burden:

Initial outbreak of corona virus disease 2019 (COVID-19) was reported from Wuhan, China in early December 2019.Presently known to be caused by a novel beta-corona virus, named as Severe acute respiratory syndrome corona virus 2 ( SARS-CoV-2).

World Health Organization (WHO) declared a pandemic on March.

The clinical characteristics of COVID-19 include respiratory symptoms, fever, cough, dyspnoea and pneumonia

Infected individuals exhibit:

1. Mostly mild illness (80% +) recover without any treatment (~80%)

2. Moderate illness that needs hospitalization and recovers after standard

3. supportive treatment (~14%)

4. Critical illness (~5%) needs ICU support

5. Death (1-2% )

COVID-19 has now spread >210 countries and territories globally. SARS-CoV-2 is a respiratory virus which spreads primarily through droplets generalized when an infected person coughs or sneezes or through droplets of saliva or discharge from the nose.

Symptomatic management remains the mainstay of treatment strategy. Mortality appears to be more common in older individuals and those with co-morbidities, such as chronic lung disease, cardiovascular disease and diabetes. Young people with no comorbidities also appear to be at risk for critical illness including multi-organ failure and death. Seen more in Bangladesh between 21-40 yrs of age.

Knowledge Gap:

There is no specific treatment against this new virus that WHO has officially declared until now.There are many pharmacologic therapies that are being used or considered for treatment of COVID-19. National Guidelines on Clinical Management of Corona virus Disease 2019 (Covid-19): V 5.0 date 9th April 2020) CDC, DGHS, GoB

Thus an RCT is urgently needed in Bangladesh: Based on recent literatures on Rx studies in COVID-19 patients from other countries as well as its availability & affordability of those repurposed medicines

Detailed Description

Objectives:

General Objective:

The aim of the study is to evaluate efficacy and safety of ivermectin in combination with doxycycline or ivermectin alone for the treatment of hospitalized SARS-CoV-2 infected adult Bangladeshi COVID-19 +ve patients and to compare with placebo; where all three arms will receive the standard care of treatment of COVID-19 infected patients in the hospital. By successful demonstration of the safety and efficacy of these repurposed medicines, it may have the potential to play an important role in the treatment of COVID-19+ve patients.

Specific Objective:

1. Duration of the virological clearance rate

2. Days required for remission of fever and cough

Secondary Objective:

• Patients requiring oxygen
• Patients failing to maintain SpO2 >88 despite oxygenation
• Number of days on oxygen support
• Chest X-ray improvement
• Duration of hospitalization
• All cause mortality

Conditions

COVID-19 Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tab Ivermectin +Cap Doxycycline

200 mcg/kg (12 mg tablet) ivermectin (IVERA) single dose and 200 mg stat doxycycline day-1 followed by 100mg doxycycline 12hrly for 4 day (i.e. day2-day5)

+ Placebo one tablet D2-5

Group Type: ACTIVE_COMPARATOR

Ivermectin + Doxycycline + Placebo

Intervention Type: DRUG

Arm I: 200 mcg/kg (12 mg tablet) ivermectin (IVERA) single dose and 200 mg stat doxycycline day-1 followed by 100mg doxycycline 12hrly for 4 day (i.e. day2-day5)

Placebo one tablet D2-5

Tab Ivermectin

Ivermectin - 200 mcg/kg (12 mg tablet) once per day D1-D5

+ Placebo two tablets D1 followed by Placebo one tablet D2-5

Group Type: ACTIVE_COMPARATOR

Ivermectin + Placebo

Intervention Type: DRUG

Arm II: Ivermectin - 200 mcg/kg (12 mg tablet) once per day D1-D5 + Placebo two tablets D1 followed by Placebo one tablet D2-5

Placebo

Drug: Placebo

3 Placebo tablets D1 followed by 2 tablets D2-5

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Arm III: 3 Placebo tablets D1 followed by 2 tablets D2-5

Interventions

Ivermectin + Doxycycline + Placebo

Arm I: 200 mcg/kg (12 mg tablet) ivermectin (IVERA) single dose and 200 mg stat doxycycline day-1 followed by 100mg doxycycline 12hrly for 4 day (i.e. day2-day5)

Placebo one tablet D2-5

Intervention Type: DRUG

Ivermectin + Placebo

Arm II: Ivermectin - 200 mcg/kg (12 mg tablet) once per day D1-D5 + Placebo two tablets D1 followed by Placebo one tablet D2-5

Intervention Type: DRUG

Placebo

Arm III: 3 Placebo tablets D1 followed by 2 tablets D2-5

Intervention Type: DRUG

Other Intervention Names

Tab IVERA +Cap Doxycycline; Tab IVERA; Tab Placebo

Eligibility Criteria

Inclusion Criteria

• Bangladeshi aged 18-65 years admitted to any of the aforementioned study sites (hospitals)
• Either sex
• At the enrollment having at least one of the following symptoms: Temp 37.5 C or above, Cough, Sore throat
• SpO2 >94%
• Duration of illness ≤ 7 days
• No oxygen support on enrollment
• Capable of swallowing oral medication
• PCR positive for SARS-CoV2 virus
• The participant properly informed about the study and agreed to sign the informed consent form (ICF)

Exclusion Criteria

• Allergy to ivermectin or doxycycline; or other contraindications to any of the study medications
• History of chronic heart disease (IHD, heart failure, documented cardiomyopathy etc)
• History of chronic liver disease (SGPT value more than 3 times of normal value)
• History of chronic kidney disease (S. Creatinine for male >1.3 mg/dL or >115 µmol/L and for female >1.2 mg/dL or >106.1 µmol/L)
• Pregnant or lactating women
• Participated in any other clinical trial within last 4 weeks
• H/o received Ivermectin/Doxycycline within last 7 days

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wasif Ali Khan, MBBS, MHS

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Locations

Icddr,B

Dhaka, , Bangladesh

Countries

Bangladesh

Other Identifiers

PR-20039

Identifier Type: -

Identifier Source: org_study_id