DOH, DOST, and PCHRD terminate conduct of Ivermectin clinical trial for COVID-19

Upon the recommendation of the Department of Health (DOH), the Department of Science and Technology – Philippine Council for Health Research and Development (DOST-PCHRD) terminated the conduct of Ivermectin clinical trials for COVID-19, which aims to evaluate the efficacy and safety of using Ivermectin in addition to standard of care among asymptomatic and non-severe COVID-19 patients. 

After several discussions, the DOST-PCHRD Governing Council (GC) composed of representatives from the DOST, Department of Health (DOH), UP Manila, National Nutrition Council (NNC), and the private sector arrived at the decision during the GC meeting held on May 11, 2022.

Secretary Fortunato T. de la Peña stated in a live broadcast of the DOST Report that among the bases for the decision were the issuance of recommendations from various international and local organizations against the use of Ivermectin for patients with COVID-19, lack of clinical trial benefits of Ivermectin based on recent studies, and the availability of effective therapeutics for the early phases of COVID-19.

Recommendations from international and local organizations

In its updated guidelines last 29 April 2022, the COVID-19 Treatment Panel of the United States National Institutes of Health (US-NIH) cited the results of several international studies on Ivermectin to reinforce its stance against the use of the drug for COVID-19, except within the context of clinical trials. Studies cited in the report include the TOGETHER trial in Brazil and the IVERCOR-COVID19 trial in Argentina. The recommendation is parallel with the statement of the World Health Organization (WHO).  

The Philippine Society for Microbiology and Infectious Diseases, Inc. (PSMID) in December 2021 also maintains in its updated Philippine COVID-19 Living Clinical Practice Guidelines on Ivermectin that there is low certainty of evidence in using Ivermectin for COVID-19. The PSMID recommends “against the use of ivermectin for the treatment of patients with COVID-19 of any severity”.

Lack of clinical trial benefits

The decision to terminate the local trial is supported by evidence obtained from recently-concluded international studies. 

Among these recent studies include the TOGETHER trial that covered a total of 3,515 participants in Brazil. In its paper published on 30 March 2022, the trial showed that the use of ivermectin “did not result in a lower incidence of medical admission to a hospital due to progression of COVID-19 or of prolonged emergency department observation among outpatients with an early diagnosis of COVID-19.”

A systematic review published this year by the Oxford University Press for the Infectious Diseases Society of America also concluded that using Ivermectin does “not reduce all-cause mortality, length of hospital stay (LOS) or viral clearance.

 

Availability of effective therapeutics for the early phases of COVID-19

In a statement released on 22 April 2022, the World Health Organization (WHO) made a strong recommendation for nirmatrelvir and ritonavir, sold under the name Paxlovid, for mild and moderate COVID-19 patients at highest risk of hospital admission.

The WHO also strongly recommended Pfizer’s oral antiviral drug (a combination of nirmatrelvir and ritonavir tablets) for patients with non-severe COVID-19 at highest risk of developing severe disease and hospitalization, such as unvaccinated, older, or immunosuppressed patients. Following the publication of new data from a clinical trial looking at the outcome of admission to hospital, WHO has also updated its recommendation on remdesivir, suggesting its use in mild or moderate COVID-19 patients who are at high risk of hospitalization.

Based on the living guideline (version 10) of WHO on COVID-19 therapeutics, the Guideline Development Group stated that several treatment alternatives are now available for patients with non-severe COVID-19 at highest risk of hospitalization. 

In the Philippines, the DOST-supported study on Lagundi showed that the standard dose of Lagundi syrup (600mg administered three times a day for 10 days) and high dose of Lagundi tablet (three times a day for 10 days) are both safe and effective treatment against COVID-19. Meanwhile, results of the community trials on virgin coconut oil (VCO) for COVID-19 showed that VCO can be used as adjunct or supplementary supplement for suspect and probable COVID-19 cases.

“In the first half of 2021, we still had very limited evidence on the safety and efficacy of drugs and therapeutics for COVID-19, including Ivermectin. The recently published studies and recommendations from international research organizations guided our Governing Council in making a well-informed decision on the termination of the trial,” says PCHRD Executive Director Jaime C. Montoya.

 

 

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