BPOM Asks Unair To Revise Clinical Trials For Combined Medicines For COVID-19

Head of the Food and Drug Administration (BPOM) Penny K. Lukito, center (photo: Diah Ayu Wardani / VOI)

JAKARTA - Head of the Food and Drug Supervisory Agency (BPOM) Penny K. Lukito, asked Airlangga University (Unair) to revise the clinical trial process for drug combinations that are predicted to be able to treat COVID-19 patients.

This is because BPOM received critical findings from the inspection process as of July 28, prior to issuing a drug distribution permit, which was formulated by Unair and sponsored by the Indonesian Army and the State Intelligence Agency (BIN).

"We found several findings that were critical (critical), especially their impact on the validity of the clinical trial process and also the validity of the results to be obtained," said Penny in a press conference at the BPOM Building, Central Jakarta, Wednesday, August 19.

Penny said, the critical findings from the results of this drug inspection, among others, still did not show a randomized representation of the population of people undergoing clinical trials of the drug.

Then, there are also positive confirmed cases without symptoms who are also given medication. "In fact, the protocol for people without symptoms does not need to be given drugs," said Penny.

In addition, BPOM found that the results of using these drugs did not show any significant differences in the patient's condition.

Furthermore, Penny said that Unair had not responded to a request for improvement in clinical trials based on the results of an inspection of a drug that was claimed to be 90 percent capable of treating COVID-19.

"We have not received this response as of today. So, I do not know what the contents of what was said earlier. Later it will be our material for further processing," said 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.