drugset / Trial / NCT04407130

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

NCT04407130

RandomizedParallel-groupDouble-blindTreatment

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

Timeline

Start
2020-06-16
Primary completion
2020-10-30
Completion
2020-11-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxycycline Small molecule 100 mg
Comparator Ivermectin Small molecule 200 ug/kg

Indications

No indication recorded.