icddr,b has started a randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of anti-parasitic medicine Ivermectin in combination with antibiotic doxycycline or Ivermectin alone.
It will be conducted on hospitalised adults diagnosed with coronavirus disease 2019 (COVID-19), icddr,b said on Wednesday.
Ivermectin is a drug for parasitic infections which has been in use since 1980 and approved by the Food and Drug Administration, USA.
It has previously shown to have broad-spectrum anti-viral activity in vitro. The study will enrol 72 patients from four COVID-19 treating hospitals in Dhaka.
Initially, the study has commenced with Kurmitola General Hospital and Mugda Medical College and Hospital and discussions with others underway.
The rate of spread of COVID-19 and its associated morbidity and mortality has been unprecedented.More than 8.2 million people worldwide have contracted the coronavirus and about 445,000 died in less than five months.
In Bangladesh, more than 90,000 people have tested positive while approximately 1,250 have died. When contracted, the virus causes respiratory illness that range from mild (coughing, fever) to severe (pneumonia, trouble breathing).
The worst cases can be fatal, especially in older adults and people with underlying health conditions.
The study aims to understand the virological clearance rate and days required for remission of fever and cough by using Ivermectin with or without doxycycline.
It will also try to understand the changes in oxygen requirement, reasons for patients failing to maintain oxygen saturation (SpO2) above 88% despite oxygenation, changes in number of days on oxygen support and hospitalisation, and causes of mortality.
Dr Wasif Ali Khan, Senior Physician Scientist of Enteric and Respiratory Diseases at icddr,b, and the principal investigator of the study said “Because of the rapid replication of this virus we need to find effective antiviral drugs against SARS-CoV-2 virus. Unfortunately, we do not have any such drugs for COVID-19 on the shelf and it may take decades to develop new ones. Therefore, we have to explore drugs that are already on the market, that are well studied, have a low side effect profile and can save lives.”
Professor John D Clemens, Executive Director at icddr,b has expressed his gratitude to Beximco Pharmaceuticals Ltd. for supporting this study.A panel of international and local experts are involved with this clinical trial.
The study will recruit participants aged between 40-65 years who have tested positive for COVID-19 with mild illness and have been suffering for less than seven days.
Patients with allergies to study medicines, suffering from underlying heart, kidney and liver problems, and pregnant or lactating women will be excluded from the study.
One group of the participants will receive a single dose Ivermectin along with five doses of doxycycline, while another group will receive Ivermectin alone once a day for five days while the third group will receive a placebo for five days.
The test medicine and placebo will be packaged identically and neither the participants nor the study physicians will have the knowledge about who is receiving which particular treatment.
Ivermectin has recently gained huge attention as a potential treatment for the new coronavirus, and a number of clinical trials are underway to see its efficacy in COVID-19.
While Ivermectin is very affordable drug and considered safe for most people, it can cause side effects including skin rash, nausea, vomiting, diarrhoea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, confusion), and sudden drop in blood pressure in a small percentage of people.
Thus, patients will undergo extensive follow-ups through physical, clinical examination, as well as laboratory checks. Follow-up is also scheduled six weeks after discharge from the hospital. All participants in the study will continue to receive clinical care as indicated for their condition.
The study is funded by Beximco Pharmaceuticals Ltd and is scheduled to end in two months.