Bangladesh launches clinical trial of two-drug combination to treat COVID-19

According to the ICDDR'B, the study will include COVID-19 patients between 40-65 years of age with mild illness for less than seven days.
In this April 15, 2020, photograph, a health worker from an aid organization walks wearing a hazmat suit at the Kutupalong Rohingya refugee camp in Cox's Bazar, Bangladesh. (Photo | AP)
In this April 15, 2020, photograph, a health worker from an aid organization walks wearing a hazmat suit at the Kutupalong Rohingya refugee camp in Cox's Bazar, Bangladesh. (Photo | AP)

JUNE: Bangladesh on Wednesday launched the clinical trial of combination of anti-parasitic and antibiotic vaccines to treat COVID-19 after getting positive results in patients administered with the mix of two drugs.

Bangladesh-based International Centre for Diarrhoeal Disease Research (ICCDR'B) said the trial would be conducted on 72 infected patients in four hospitals treating COVID-19 in Dhaka, while “the study has commenced in Kurmitola General Hospital and Mugda Medical College and Hospital and discussions with others are underway."

“Today, ICCDR 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.

A Bangladeshi doctors' team led by senior medicine specialist Professor Tarek Alam prescribed the combination as it initially cured within days all the 60 COVID-19 patients who were administered with the drugs.

According to the ICDDR'B, the study will include COVID-19 patients between 40-65 years of age with mild illness for less than seven days.

One group of 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 physicians will have the knowledge about who is receiving which treatment.

According to a statement by the ICDDR'B, a panel of international and local experts were involved with this clinical trial which will be concluded in next two months.

The ICDDR's announcement came hours after the country's healthcare authorities said experts concerned were asked to quicken examinations on the efficacy of a two-drug combination and studies on it were underway in line with medical protocols.

Nearly 100,000 people have tested positive for COVID-19 in Bangladesh, while approximately 1,305 patients have died, 43 of them in the last 24 hours.

The centre said their study, being supported by Bangladesh's leading drug maker 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 per cent 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 called the proposed clinical trial “well designed” and first such randomised 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 is previously shown to have “broad-spectrum anti-viral activity in vitro”.

Director General of Directorate General of Health Services (DGHS) Abul Kalam Azad earlier said that once a technical study team of his office gave a go ahead, 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).

“These are low-cost drugs, Bangladesh will be proud, if the combination is proven effective against the coronavirus,” said Health Ministry's additional secretary Habibur Rahman Rahman.

Head of medicine of private Bangladesh Medical College Hospital (BMCH) 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.

Doctors at different facilities said they were unofficially using the matching, observing their effectiveness.

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