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Recruitment of PH ivermectin trial participants to start Oct. 15 and due to finish in February 2022


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(File photo)

 

MANILA – Department of Science and Technology (DOST) Secretary Fortunato de la Peña on Monday said recruitment of participants for the clinical trials on the use of ivermectin in the Philippines will start on Oct. 15.

De la Pena made this clarification after he erroneously indicated in his presentation during President Rodrigo Duterte’s prerecorded Talk to the People aired on Saturday that the recruitment will begin on Sept. 15.

"I told the President we can finish by February. We hope to get initial analysis by December 2021. We hope the project could be finished by February 2022," he said in a Viber message to the Philippine News Agency (PNA).

The memorandum of agreement between the DOST and the University of the Philippines (UP) Manila was signed last Aug. 17.


"There were revisions in methodology, still to be approved by the technical committee and the research ethics committee," he added.

He said the World Health Organization did not endorse ivermectin for Covid-19 use, but only for clinical trial purposes.

 

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Ivermectin is the seventh treatment to be investigated in the trial, and is currently being evaluated alongside antiviral drug favipiravir. Representative image

“The Philippine ivermectin clinical trials are justified because of varying results in different countries," de la Peña said.

Philippine clinical trials are internationally peer-reviewed and are aligned with the International Clinical Trial Consortium for ivermectin.

In a separate message to PNA, Philippine Council for Health Research and Development (PCHRD) executive director Jaime Montoya said the country will pursue the ivermectin clinical trial as this will provide local data with regard to the safety and efficacy of ivermectin.

"(It is also) to respond to the WHO's call to conduct quality clinical trials, because of the insufficiency of good evidence for use or non-use of ivermectin," Montoya said.

Earlier, Montoya said it would be good for the country to document the local experiences, how the participants would respond, and if there would be adverse effects.

Meanwhile, de la Peña said the Department of Health (DOH) requested and funded the ivermectin clinical trials, and it will be the DOH that will decide what actions to take when the study results are out.

"Clinical trials take some time. The (ivermectin clinical trial) is actually shorter than other projects because of simultaneous recruitment and short duration of treatment," he said.

The country eyes to include 1,464 participants, a combination of symptomatic and asymptomatic patients, according to de la Peña. (PNA)

 

Notes: The current evidence on the use of ivermectin to treat COVID-19 patients is inconclusive. Until more data is available, WHO recommends that the drug only be used within clinical trials.

 

This recommendation, which applies to patients with COVID-19 of any disease severity, is now part of WHO’s guidelines on COVID-19 treatments.

 

Ivermectin is a broad spectrum anti-parasitic agent, included in WHO essential medicines list for several parasitic diseases. It is used in the treatment of onchocerciasis (river blindness), strongyloidiasis and other diseases caused by soil transmitted helminthiasis. It is also used to treat scabies.

 

A guideline development group was convened in response to the increased international attention on ivermectin as a potential treatment for COVID-19. This group is an independent, international panel of experts, which includes clinical care experts in multiple specialties and also include an ethicist and patient-partners.

 

The group reviewed pooled data from 16 randomized controlled trials (total enrolled 2407), including both inpatients and outpatients with COVID-19. They determined that the evidence on whether ivermectin reduces mortality, need for mechanical ventilation, need for hospital admission and time to clinical improvement in COVID-19 patients is of “very low certainty,” due to the small sizes and methodological limitations of available trial data, including small number of events. 

 

The panel however did not look at the use of ivermectin to prevent COVID-19, which is outside of scope of the current guidelines.

 

 

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