- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04407130
Efficacy and Safety of Ivermectin and Doxycycline in Combination or IVE Alone in Patients With COVID-19 Infection.
Ivermectin and Doxycycline in Combination or Ivermectin Alone for the Treatment of Adult Bangladeshi Patients Hospitalized for COVID-19: a Randomised, Double-blind, Placebo-controlled Trial.
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:
- Mostly mild illness (80% +) recover without any treatment (~80%)
- Moderate illness that needs hospitalization and recovers after standard
- supportive treatment (~14%)
- Critical illness (~5%) needs ICU support
- 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
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Duration of the virological clearance rate
- 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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh, 1000
- Icddr,b
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criterion:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 |
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
Other Names:
|
Active Comparator: 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 |
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
Other Names:
|
Placebo Comparator: Placebo
Drug: Placebo 3 Placebo tablets D1 followed by 2 tablets D2-5 |
Arm III: 3 Placebo tablets D1 followed by 2 tablets D2-5
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Virological clearance
Time Frame: within 7 days after enrollment
|
• Presence of virus will be negative on Day 7 detected by RT PCR
|
within 7 days after enrollment
|
Remission of fever
Time Frame: within 7 days after enrollment
|
• Body temperature will be < 37.5 C by day 7 detected by Infrared thermometer
|
within 7 days after enrollment
|
Remission of cough
Time Frame: within 7 days after enrollment
|
• Remission of cough: No signs of cough showing respiratory rate within 12-20/ min, on day7
|
within 7 days after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients requiring oxygen
Time Frame: within 7 days after enrollment
|
Detected SPO2 level <94% on Day 7or before by pulse oxymeter
|
within 7 days after enrollment
|
Patients failing to maintain SpO2 >93% despite oxygenation
Time Frame: within 7 days after enrollment
|
Patients who fail to maintain pulse oxymeter detected SpO2 level>93% despite O2 supplementation of 2-6 L/min, on Day 7 or before
|
within 7 days after enrollment
|
Number of days on oxygen support
Time Frame: within 7 days after enrollment
|
Any number of days on oxygen support on Day 7 or before recorded in CRF
|
within 7 days after enrollment
|
Duration of hospitalization
Time Frame: within 14 days after enrollment
|
Hospital stay ≥7days to ≤14 days as per CRF records
|
within 14 days after enrollment
|
All causes of mortality
Time Frame: within 14 days after enrollment
|
Death any time during 14 days of study period from any cause recorded in CRF and Hospital death certificate
|
within 14 days after enrollment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Wasif Ali Khan, MBBS, MHS, International Centre for Diarrhoeal Disease Research, Bangladesh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Anti-Infective Agents
- Anti-Bacterial Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Doxycycline
- Ivermectin
Other Study ID Numbers
- PR-20039
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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