DOST to start clinical trial on ivermectin by end of May

Marje Pelayo   •   May 4, 2021   •   95

MANILA, Philippines — Following order from President Rodrigo Duterte, the Department of Science and Technology (DOST) will launch a clinical trial on anti-parasitic drug ivermectin to determine its effectiveness in treating coronavirus disease (COVID-19).

According to DOST- Philippine Council for Health, Research and Development Executive Director Dr. Jaime Montoya, the clinical trial is likely to begin in the last week of May or first week of June this year.

Montoya said the research team has already discussed the procedures of the trial and where it will be conducted as well as the members that will be involved.

The plan will be submitted to the Department of Science and Technology (DOST) and the Food and Drug Administration (FDA) for issuance of permit.

The trial will use ivermectin in tablet form which can be sourced from local manufacturers or possibly abroad wherever it is available.

The duration and the results of the trial will depend on the condition of volunteer patients with mild and moderate symptoms of COVID-19 and those quarantined in facilities managed by the Philippine Red Cross (PRC) in Metro Manila.

 

Clinical trials on ivermectin to start in June – DOST

Marje Pelayo   •   May 6, 2021

MANILA, Philippines – Department of Science and Technology (DOST) Secretary Fortunato dela Peña said that preparations are underway for the anticipated clinical trials on the use of ivermectin as a treatment for COVID-19.

In his report to President Rodrigo Duterte on Wednesday (May 5), the official said the trials will be spearheaded by pulmonary doctor Dr. Aileen Wang of the University of the Philippines – Philippine General Hospital (UP-PGH) and will be implemented for eight months from June 2021 to January 2022.

He said the Department of Health (DOH) has allotted a total of P22 million for the trial of ivermectin.

It will be conducted on 1,200 volunteer adults, 18 years old and above, who are asymptomatic or non-severe COVID patients.

The team is awaiting ethics approval this month before proceeding with the trial.

“Ang ginagawa ay ethics approval para sa kanilang gagawin at recruitment ng staff na mag-a-administer ng clinical trials,” Dela Peña said.

They are currently coordinating with the Philippine Red Cross for the utilization of its facilities.

Other agents also under clinical trial are as follows:

* Randomized control clinical trial on the efficacy and safety of Tawa Tawa for adjunctive treatment of mild to moderate COVID-19 patients (11 months);

* Randomized, placebo-controlled trial on the safety and efficacy of Lagundi in patients with mild COVID and without comorbidities (10 months);

* Clinical trial on the safety and efficacy of virgin coconut oil (VCO) as adjunctive therapy for hospitalized COVID patients (12 months);

* Beneficial effects of VCO among suspect and probable cases of COVID-19 (14 months, extension included);

* Melatonin as adjuvant treatment for COVID-19 in patients requiring hospitalization (9 months) ;

* Convalescent Plasma as adjunctive therapy for hospitalized COVID-19 patients. (12 months).

Dela Peña noted that the duration of clinical trials for ivermectin is almost similar in period as other agents. The progress of each study still depends on the number of patients who want to volunteer for the trial.

“Kapag dumadami ang pasyenteng magbo-volunteer, mas mapapabilis ang pagtatapos ng mga trials,” the official assured.

BOC-NAIA intercepts 20,000 tablets of ivermectin, other regulated drugs

Maris Federez   •   May 6, 2021

MANILA, Philippines — The Bureau of Customs Port of NAIA (BOC-NAIA) has intercepted undeclared ivermectin and other regulated drugs declared as food supplements and multi-vitamins and multi-mineral capsules.

In a press release dated May 6, the BOC said the shipment was imported by Finstad Inc. from New Delhi, India.

The said drugs including the undeclared 20,000 capsules of ivermectin were reportedly concealed in the inner portion of the subject shipment along with other declared regulated items, it added.

The BOC said that it coordinated with the Food and Drug Administration (FDA) regarding the shipment.

In her reply to a BOC query, FDA Director Jesusa Joyce N. Cirunay of the Center for Drug Regulation and Research said, “At present, the drug is under compassionate use in Specialized Institutions authorized by FDA through the issuance of Compassionate Special permit (CSP).”

Furthermore, Director Cirunay added, “In case ivermectin has been granted authorization, a valid License to Operate (LTO) as Drug Importer and Emergency Use Authorization (EUA) or Certificate of Product Registration (CPR) shall be presented.”

The BOC-NAIA team said that in conformance with the directive of Customs Commissioner Rey Leonardo B. Guerrero, it remains committed to expediting the processing and release of Covid-19 vaccines, drugs, and other medical supplies.

Moreover, it assured that it will also be vigilant and will further strengthen border security and protection efforts to curb all smuggling attempts to import unregistered, undeclared goods and/or misdeclared goods without the necessary clearance and permits from FDA.

FDA: 6 hospitals have secured special permit for ivermectin use vs COVID-19

Robie de Guzman   •   May 5, 2021

MANILA, Philippines — Another hospital has secured a compassionate special permit (CSP) for the use of ivermectin to treat patients with coronavirus disease (COVID-19), the Food and Drug Administration (FDA) said Wednesday.

FDA director-general Eric Domingo said there are now six hospitals within and outside Metro Manila that have been allowed limited use of the anti-parasitic drug on COVID-19 patients.

“That means the doctors in the hospitals can prescribe it [ivermectin],” he said in an online forum.

Domingo declined to identify these hospitals with CSP since the FDA doesn’t want to “violate the privacy of the patients.”

“Of course, the hospitals can freely identify themselves. We’re not stopping them,” he added.

The FDA earlier said that a compassionate special permit only allows experimental or unregistered drugs for limited off-label use but this is not an agency’s endorsement of its safety and efficacy.

Only the hospital that has secured a permit for ivermectin’s compassionate use for humans will be allowed to import the drug through a licensed importer.

Doctors who will prescribe the drug to treat COVID-19 patients are required to report to the FDA on a monthly basis. They will also be held liable for possible side effects.

The FDA also reiterated that a compassionate use permit is different from a certificate of product registration for the drug, which allows manufacturers to commercially sell the anti-parasitic drug for human use.

Domingo likewise stressed that the drug is still an investigational product and is not yet approved as COVID-19 treatment in the country.

The clinical trial for ivermectin as possible COVID-19 treatment is expected to start in May or June.

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