The International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) has begun human trials of the much-talked-about anti-parasitic drug Ivermectin with a view to observing its efficacy in the treatment of patients infected with coronavirus as the drug has recently been at the centre of attention.
icddr,b on Wednesday said they had started a “randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy” of Ivermectin in combination with antibiotic doxycycline or Ivermectin alone.
It will be conducted on hospitalised adults diagnosed with coronavirus disease. The study is funded by Beximco Pharmaceuticals Ltd and is scheduled to end in two months.
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 enroll 72 patients from four COVID-19 treating hospitals in Dhaka.
Initially, the study will be conducted at Kurmitola General Hospital and Mugda Medical College and Hospital, and discussions with others are underway, icddr,b said.
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, icddr,b said.
Senior Physician Scientist of Enteric and Respiratory Diseases of icddr,b Dr Wasif Ali Khan is the principal investigator of the study. Besides, a panel of international and local experts is 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.
While Ivermectin is a 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.
Prof John D Clemens, Executive Director at icddr,b, expressed his gratitude to Beximco Pharma for supporting this study.
“I appreciate Beximco Pharma’s support towards our endeavour to know how safe and effective Ivermectin is in treating patients suffering from the novel coronavirus infection. It is extremely important to find an affordable and easy-to-use treatment option to fight against this pandemic in low- and middle-income countries like Bangladesh.”
Beximco Pharma Managing Director Nazmul Hassan MP was quoted as saying in a statement that they were also pleased to sponsor the first randomised, well designed clinical trial of Ivermectin in Bangladesh.
It is mentionable that 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 already died.