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COVID-19-DRUG-BANGLADESH-2nd LEAD
ICDDR’B begins two-drug combination’s clinical trial for COVID-19
(Recasts)
By Morshadur Rahman
DHAKA, June 17, 2020 (BSS) – Bangladesh-based global health research institute ICDDR’B today said it launched the clinical trial of a two-drug combination developed recently by a team led by a senior Bangladeshi doctor, claiming it worked very well in curing COVID-19 patients at a minimal cost.
“Today, 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,” the centre said in a statement.
It said the trial would be conducted enrolling 72 infected patients in four COVID-19 treating hospitals in Dhaka while “the study has commenced with Kurmitola General Hospital and Mugda Medical College and Hospital and discussions with others are underway”.
According to the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) statement a panel of international and local experts were involved with this clinical trial which will be concluded in next two months.
The ICDDR’B announcement came hours after the country’s healthcare authorities said experts concerned were asked to quicken examinations of efficacy of a two-drug combination studies on it were underway in line with medical protocols.
The centre said their study, being supported by ICDDR’B would run the study with supports of Beximco Pharmaceuticals Ltd., aimed 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,” the statement read.
Beximco Pharma Managing Director Nazmul Hassan MP in another statement called the proposed clinical trial “well designed” and first such randomized experiment in the country.
“Should the outcomes be positive from this trial, as well as other ongoing trials in different countries, Ivermectin can offer itself as a highly affordable and readily available solution for the COVID-19 pandemic,” he said.
US Food and Drug Administration (FDA) earlier approved ivermectin as a drug for parasitic infections while it has been in use since 1980 and according to ICDDR’B it previously shown to have “broad-spectrum anti-viral activity in vitro”.
Director General of Directorate General of Health Services (DGHS) Prof Abul Kalam Azad earlier today told BSS that once a technical study team of his office gave the green, light the combination drugs would be prescribed for “limited-scale application” among COVID-19 patients.
He said ahead of a massive-scale application or widened use to treat COVID-19 patients, the combination would have to exhaust clinical trials under the supervision of regulatory Bangladesh Medical Research Council (BMRC).
Health ministry’s additional secretary Habibur Rahman, meanwhile, said concerned officials and experts took the issue with a positive outlook and were extending all-out cooperation to the research team.
“These are low-cost drugs, Bangladesh will be proud, if the combination is proven effective against the coronavirus,” said Rahman, who also heads the health ministry’s media cell.
Head of medicine of private Bangladesh Medical College Hospital (BMCH) Professor Tarek Alam led the team in experimenting the combination which he said worked very well for mild and moderate cases of coronavirus.
He said the team now wanted to see the combination’s effectiveness on patients with severe coronavirus infections administering them with increased doses of medicines.
Alam said his team submitted a proposal incorporating treatment protocol on 60 patients to BMRC seeking the clinical trial, while three hospitals – Bangladesh Medical College Hospital, Central Police Hospital and Uttra Adhunic Hospital – were selected for carrying out the experiment.
“We will categorize doses of two-medicine combination as mild, moderate and severe during clinical trial,” Alam said.
The development in Bangladesh came a day after British researchers said they found the first drug – Dexamethasone – proven to cut COVID-19 deaths which could be of huge benefit of poorer countries with high infection rates because of its low cost.
It appears that when the low-cost Dexamethasone, a steroid group drug, worked on critical patients on ventilation or on extra-oxygen supplies, the combination of Ivermectin with doxycycline appeared highly effective in treating patients with less severe crronavirus infections.
“It (Dexamethasone) cut the risk of death by a third for patients on ventilators. For those on oxygen, it cut deaths by a fifth,” BBC reported concerned experts in UK while the Reuters news agency quoting England’s chief medical officer Chris called the development “the most important trial result for COVID-19 so far”.
“It will save lives around the world,” Whitty said while researchers familiar with the study said had the drug been used to treat patients in the UK from the start of the pandemic at least 5,000 lives could have been saved.
Alam’s team also believe a widespread use of the combination under doctors careful monitoring could largely contain death rates had it been applied from the beginning of the pandemic since their initial experiment found all the 60 patients recovered after using the two drugs within a week.
“(But) we have heard many people are taking these medicines without doctor’s prescription . . . it is a dangerous practice. I warn everyone not to take medicines without consulting doctors,” Alam said.
Dr Rubaiul Morshed, a member of Alam’s medical team said the two-drug combination was an inexpensive treatment which could be plied globally for coronavirus patients.
Doctors at different facilities said they were unofficially using the matching, observing their effectiveness.
Head of National Advisory Technical Committee on COVID-19 and president of regulatory Bangladesh Medical and Dental Council Prof Dr Mohammad Shahidullah said eventually it could appear as major medical advancement.
“A research team got good result for treatment of coronavirus patients through their observation but a randomised control trial (RCT) needs to be conducted for assessment of the effectiveness of the combination,” Shahidulah said earlier.
But doctors at the central police hospital said their findings in experimenting Ivermectin combination with doxycycline in a regulated method replicating Tarek Alam’s formula visibly lowered the mortality rate.
“Mortality rate is less than one percent in our hospital while the national fatality rate is 1.34 percent,” Central Police Hospital chief and police’s deputy inspector general Dr Hasan Ul Haider.
The ICDDR’B statement said the centre’s Senior Physician Scientist of Enteric and Respiratory Diseases Dr Wasif Ali Khan would oversee the two-drug combination study as its principal investigator.
Khan, meanwhile said since no drugs for COVID-19 was on the shelf right now, “we have to explore drugs that are already in the market, that are well studied, have a low side effect profile and can save lives”.
ICDDR’B executive director Professor John D Clemens welcomed Beximco Pharma’s support towards its 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,” he said.
According to the ICDDR’B, 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.
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.
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