JAKARTA - Head of the Food and Drug Supervisory Agency (BPOM) Penny Lukito explained the factors or findings from the inspection that caused the clinical trial phase III of the COVID-19 drug at Universitas Airlangga (Unair) to be declared valid.
Penny said, these critical findings fall into two categories, namely major and minor, and will have an impact on the results of the validity of the clinical trials studied since July 28. As a result, this drug has not received a distribution permit from the BPOM.
First, the subject of the COVID-19 patient population who underwent a phase III clinical trial of the Unair herb medicine and sponsored by the Indonesian Army and the State Intelligence Agency (BIN) has not represented all Indonesian people.
"Of the patients as selected subjects, they still do not represent the diversity according to the existing protocol. This is associated with demographic variations, degrees of pain or severity. Starting from mild, moderate and severe degrees," said Penny in a press conference at the BPOM Building, Central Jakarta, Wednesday, August 19.
Subsequently, the BPOM found that clinical trial administrators of this drug also selected a population of clinical trial participants of people who were confirmed positive but without any symptoms.
"In fact, the protocol is that people without symptoms do not need to be given drugs. We have to lead to minor illnesses, moderate illnesses, and serious illnesses," said Penny.
In addition, Penny explained that the use of the Unair COVID-19 medicine did not show any significant changes. In fact, this drug is claimed to cure corona virus patients with a 90 percent cure rate.
"The results have not shown a very significant difference. In this research, it must show that something that has been intervened recently produced significant results. So, we need to follow up further," he said.
Therefore, BPOM asked Unair to revise the clinical trial process for the COVID-19 drug combination before BPOM issued a distribution permit, before finally being disseminated to the public.
"We have conveyed critical corrections and several other findings, so that we get a process and later it should be a valid result and we can give permission for emergency use authorization," explained Penny.
As is known, on July 3, Unair, TNI AD, and BIN conducted a phase 3 clinical trial for the use of the COVID-19 combination drug that they studied. Oang does not yet have that name claimed to be able to kill the corona virus up to 90 percent in 3 days.
The drug has three types of combination. First, Lopinavir / Ritonavir and Azithromycin. Second, Lopinavir / Ritonavir and Doxycycline. Third, Hydrochloroquine and Azithromyci.
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