BPOM Critical Findings When Inspecting Unair's COVID-19 Cure Trials

TEMPO.CO, Jakarta - The Food and Drug Monitoring Agency (BPOM) head Penny Lukito disclosed the results of the inspection to the clinical trial of drug combinations to cure COVID-19 developed by Airlangga University (Unair).

“We found several gaps classified into critical, major, minor,” said Penny in a press conference, Wednesday, August 19.

Penny explained that critical findings from the audit carried out on July 28, would bring impacts on the validity of the clinical trials process and the result obtained.

The first finding was related to randomization. According to Penny, the trial subjects did not represent diverse groups based on the protocol, for example, stratifying patients by geographic and their severity level.

Moreover, the drug combination was given to patients without symptoms, while the protocols noted that asymptomatic carriers did not need to consume medicine.

“We must target [the trials] on people developing light, medium, and severe symptoms. Representation of each group must be involved,” the BPOM head stressed.

Penny went on that the research conducted by Unair in cooperation with the State Intelligence Agency (BIN) and the Military (TNI) had not yet shown significant results compared to standard therapy. Thus, the efficacy of the claimed drug needed to be addressed further.

Besides, given the powerful drug combinations claimed by Unair as COVID-19 cure, Penny highlighted the importance of the dosage examined during the research. “It is associated with the side effect and resistance to antivirals,” she said.

Read: COVID-19 Research Consortium: No Cure Available To Date

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