A Phase 2 interventional study of Ivermectin + Doxycycline + Placebo and Ivermectin + Placebo in COVID-19 Patients, sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. Completed at 1 site in Bangladesh. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh · Phase 2, Interventional, and Treatment
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:
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
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:
Secondary Objective:
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 72 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →International Centre for Diarrhoeal Disease Research, Bangladesh is the lead sponsor of 197 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: Ivermectin + Doxycycline + Placebo
Ivermectin - 200 mcg/kg (12 mg tablet) once per day D1-D5 + Placebo two tablets D1 followed by Placebo one tablet D2-5
Drug: Ivermectin + Placebo
Drug: Placebo 3 Placebo tablets D1 followed by 2 tablets D2-5
Drug: 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
Also known as: Tab IVERA +Cap Doxycycline
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
Also known as: Tab IVERA
Arm III: 3 Placebo tablets D1 followed by 2 tablets D2-5
Also known as: Tab Placebo
Virological clearance
• Presence of virus will be negative on Day 7 detected by RT PCR
Time frame: within 7 days after enrollment
Remission of fever
• Body temperature will be \< 37.5 C by day 7 detected by Infrared thermometer
Time frame: within 7 days after enrollment
Remission of cough
• Remission of cough: No signs of cough showing respiratory rate within 12-20/ min, on day7
Time frame: within 7 days after enrollment
Patients requiring oxygen
Detected SPO2 level \<94% on Day 7or before by pulse oxymeter
Time frame: within 7 days after enrollment
Patients failing to maintain SpO2 >93% despite oxygenation
Patients who fail to maintain pulse oxymeter detected SpO2 level\>93% despite O2 supplementation of 2-6 L/min, on Day 7 or before
Time frame: within 7 days after enrollment
Number of days on oxygen support
Any number of days on oxygen support on Day 7 or before recorded in CRF
Time frame: within 7 days after enrollment
Duration of hospitalization
Hospital stay ≥7days to ≤14 days as per CRF records
Time frame: within 14 days after enrollment
All causes of mortality
Death any time during 14 days of study period from any cause recorded in CRF and Hospital death certificate
Time frame: within 14 days after enrollment
Plan to share: No
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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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International Centre for Diarrhoeal Disease Research, Bangladesh