THE PHILIPPINES has agreed to be part of the Covid-19 Solidarity Trial launched by the World Health Organization and its partners.
This was also confirmed by Undersecretary Rowena Cristina Guevara, of the Department of Science and Technology (DOST). “The LOA indicates the support and participation of the Philippines in the trials, to determine the most effective Covid-19 vaccines suitable for the Filipinos, and the effective number of doses,” she said, referring to the letter of agreement the government signed with WHO.
Guevara said the study also aims to determine which among the Covid-19 vaccines could provide the longest protection, and which could be easily administered and manufactured in the country.
The clinical trials would start once all the legal documents are signed, according to Guevara, saying, at present the Philippines is preparing the hospital sites and the target communities in selected cities in the National Capital Region where the trials will be conducted.
Guevara said qualified participants would undergo the initial screening of a local vaccine team or a doctor assigned at the trial site, following the WHO protocol. With regard to the study on using mixed brands of Covid-19 vaccines, she said the country has started the preparations.
She said some 3,000 individuals are being eyed to participate in this study. “To ensure the consistency and uniformity in the trials, we will only include those who are not yet inoculated with Covid-19 vaccines,” she said.
The cities of Manila, Pasig, Antipolo, Marikina, Makati, Pasay, Muntinlupa, Cebu, and Davao are being proposed for the mix and match study, according to Guevara.
“Clinical trials have a Phase 2 and 3, just like the solidarity vaccine trial, and other privately-funded trials. These vaccines could not yet be used in the national vaccination program because these have yet to pass the Phase 3 satisfactory results,” she said. “When the vaccine passes the Phase, this can be included in the country's options for deployment in vaccination programs. The clinical trials will not affect the global scarcity in vaccine supply.”
Guevara noted that clinical trials are being conducted to assess the safety and efficacy, and immunogenicity of the vaccines. “The positive outcome of these studies will be based on data and evidence needed for registration and approval of vaccines for commercialization,” she said.
Solidarity is an international clinical trial to help find an effective treatment for the deadly respiratory disease and it is one of the largest international randomized trials for Covid-19 treatments, enrolling almost 12 000 patients in 500 hospital sites in over 30 countries.
The Solidarity Trial is evaluating the effect of drugs on 3 important outcomes in Covid-19 patients - mortality, need for assisted ventilation and duration of hospital stay.
The Solidarity Trial compares treatment options against standard of care to assess their relative effectiveness against Covid-19. By enrolling patients in multiple countries, the Solidarity Trial aims to evaluate whether any of the drugs improve survival or reduce the need for ventilation or duration of hospital stay. Other drugs may be added based on emerging evidence.
In general, until there is sufficient evidence, WHO cautions against physicians and medical associations recommending or administering unproven treatments to patients with Covid-19 or people self-medicating with them.
The Solidarity Trial published interim results on October 15, 2020 and it found that all 4 treatments evaluated (remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon) had little or no effect on overall mortality, initiation of ventilation and duration of hospital stay in hospitalized patients. The Solidarity Trial is considering evaluating other treatments, to continue the search for effective Covid-19 therapeutics.
So far, only corticosteroids have been proven effective against severe and critical Covid-19. Previously, on July 4, 2020, WHO had accepted the recommendation from the Solidarity Trial’s International Steering Committee to discontinue the trial’s hydroxychloroquine and lopinavir/ritonavir arms.
The International Steering Committee formulated the recommendation in light of the evidence for hydroxychloroquine vs standard-of-care and for lopinavir/ritonavir vs standard-of-care from the Solidarity Trial interim results, and from a review of the evidence from all trials presented at the July 1-2 WHO Summit on Covid-19 research and innovation. These interim trial results showed that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized Covid-19 patients when compared to standard of care.
Solidarity Trial investigators interrupted the trials with immediate effect. For each of the drugs, the interim results did not provide solid evidence of increased mortality. There were, however, some associated safety signals in the clinical laboratory findings of the add-on Discovery trial, a participant in the Solidarity Trial. These will also be reported in the peer-reviewed publication.
This decision applies only to the conduct of the Solidarity Trial in hospitalized patients and does not affect the possible evaluation in other studies of hydroxychloroquine or lopinavir/ritonavir in non-hospitalized patients or as pre- or post-exposure prophylaxis for Covid-19. (Maria Cristina Arayata, Mindanao Examiner)
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