Use of Ivermectin: Hope held out, caution called for

Physicians at a Dhaka hospital claimed they have observed "cumulative efficacy" of ivermectin in Covid-19 patients while using the drug in combination with doxycycline.

They said although they were yet to be certain about the exact efficacy of the drug combination, they would seek permission from Bangladesh Medical and Research Council (BMRC) for a clinical trial to know further about its effectiveness.

The BMRC has recently permitted International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) to run a clinical trial of the drug combination, according to an official.

Experts, however, cautioned the drugs should not be used based on only such "observation". The suggested conducting a dose-response study using a clinical trial.

Introduced in 1987, ivermectin is a medication used to treat many types of parasite infestations which include head lice, scabies, river blindness, strongyloidiasis, trichuriasis, ascariasis, and lymphatic filariasis.

A research article published at www.sciencedirect.com on April 3 described the effect of the FDA-approved ivermectin on SARS-CoV-2 in a laboratory setting done by a group of researchers in Monash University, Australia.

The Monash team found ivermectin in vitro [performed outside of a living organism] had an inhibitory action on the novel coronavirus, reducing the load of viral RNA by 5,000 times in 48 hours. The ivermectin dose used in this study was 5 μM.

Based on this study, Prof Tareq Alam, head of the medicine department at Bangladesh Medical College and Hospital (BMCH), in mid-April administered ivermectin and doxycycline to one of his senior female colleagues with comorbidities for ten days. She was asymptomatic, but she tested positive for Covid-19.

The patient tested negative for the virus in seven days.

Later, the same medications were administered to 60 other Covid-19 patients -- mostly staffers of BMCH.

Four of them tested negative in the second test on the fourth day of taking the drug combination. The average duration for recovery of the patients was 11 days.

Of the 60 patients, three had fever of more than 103 degrees Fahrenheit for seven days with severe cough and lung infiltrates, three others had severe loose motion and one had uncontrolled diabetes.

Besides, 30 had mild symptoms of malaise, sore throat, and body ache, and the rest were asymptomatic.

Indian newspaper The Hindustan Times also ran a story on the effectiveness of ivermectin, quoting Prof Tareq and his co-researcher Prof Rubaiul Murshed.

"Within 72 hours of administering these drugs, majority of the patients' condition started improving," said Tareq, also a member of a health research organisation "Shomman Foundation".

Tareq said they had to depend on the Institute of Epidemiology, Disease Control and Research for testing. "For this reason, we could not test the samples from all the patients within four days. I think the majority of the patients would have tested negative within four days if they were tested on time."

He, however, cautioned that ivermectin should not be administered to pregnant or breastfeeding women, children under five or weighing below 15 kg, and patients with liver diseases.

On April 22, physicians at the Central Police Hospital (CPH) in the capital's Rajarbagh also started administering the drug combination to the police personnel who were showing Covid-19-like symptoms.

At the CPH, ivermectin was given to around 2,500 patients, mostly aged between 30 and 56, till yesterday.

"Ivermectin is not a magic bullet, but we observed good results using it when the patients started showing the symptoms. We also used several other drugs, including doxycycline, favipiravir, and azithromycin in the treatment," Hasan Ul Haider, director of CHP, told The Daily Star.

Around 7,800 police personnel tested positive for novel coronavirus across the country till Friday. Of them, 20 have died.

"For patients with severe conditions, ivermectin has no effects. As it works reducing replication of the novel coronavirus in the patient's body at the early stage, our physicians gave the drug to those police personnel who start showing symptoms even if they were not tested. The recovery time of the patients in our hospital is 10 days on average," Hasan Ul Haider said.

Asked when the patients showed signs of improvement, he said almost 85 percent patients showed mild symptoms and they recovered within 10-12 days.

He said the recovery rate was 2.5 times higher among the CPH patients than those in general hospitals which was 21.13 percent yesterday.

Physicians at CPH and Prof Tareq are now sharing their experiences on the use of ivermectin.

Prof Rubaiul, also an honorary chief consultant at CPH, said their experiences encouraged them to go for a clinical trial. "We will soon submit a proposal to Bangladesh Medical and Research Council in this regard."

Speaking to this newspaper, BMRC Director Dr Mahmood-uz-jahan said, "They have contacted us in this regard. We are thinking of permitting them for a clinical trial."

He, however, cautioned that no drug should be recommended for treating a Covid-19 patient without a scientific study of it and also without a doctor's prescription.

Prof Dr Md Sayedur Rahman, chairman of pharmacology department at Bangabandhu Sheikh Mujib Medical University (BSMMU), echoed the views of Mahmood-uz-jahan.

"If they find any efficacy of the drug combination, then it can be tested in clinical trials. Otherwise, people will get a wrong message," said Sayedur, also a member of National Research Ethics Committee at BMRC.

ICDDR,B STUDY

An icddr,b official said they [icddr,b] have a plan to run the efficacy trial.

He, however, refused to give details on the trial.

Physicians said if the clinical trials were successful, it would pave the way for using the combination of drugs on a larger scale.

However, multiple trials should be conducted in different countries successfully before the drug combination get official approval of the governments across the world, they added.

Although there is a discussion on the efficacy of ivermectin, the FDA of the US, is yet to authorise emergency use for this WHO-listed essential drug to prevent or treat coronavirus or COVID-19.

No therapy to date has been shown to improve survival for patients infected with novel coronavirus. Hundreds of clinical studies are underway across the world to find effective drugs to treat Coid-19 patients.

The World Health Organization and its partners have launched a "solidarity trial" to compare four treatment options against standard of care, to assess their relative effectiveness against Covid-19.Until there is sufficient evidence, WHO cautioned against physicians and medical associations recommending or administering these unproven treatments to patients with Covid-19 or people self-medicating with them.