BODY The Food and Drug Administration (Badan POM) gave approval for Covifor drugs containing Remdesivir to be used for Covid-19 patients. However, the drug must first undergo clinical trials this October.
As explained by the Country Manager of PT Amarox Pharma Global, Sandeep Sur, the Covifor medicine itself has actually gone through strict clinical trials, but the regulations given by the POM to conduct clinical trials again in Indonesia must be followed.
“The clinical trial will be conducted this October and will involve 25 Covid-19 patients with severe conditions. The duration of the study is three months,” he explained in a written statement received by Okezone, Saturday (3/10/2020).
Previously, the Persahabata Hospital Lung Specialist Dr. Erlina Burhan, SpP (K), explained that the 25 Covid-19 patients were taken from his place of practice.
However, Dr. Erlina explained, there are several characteristics of Covid-19 patients who cannot participate in the Covifor administration trial. They are Covid-19 patients who have a history of allergies, kidney and liver disorders.
“Furthermore, patients who are currently participating in other drug research cannot participate in the Covifor trial,” added Dr. Erlina. These requirements, said Dr. Erlina, are in accordance with the protocol published in the hospital ethics committee.
Not just any patient is selected, they must meet the following criteria;
1. The patient’s age is over 18 years.
2.Covid-19 has been confirmed.
3. The patient is in a critical situation, with a marked oxygen saturation below 94 percent.
4. The patient is undergoing treatment using a ventilator.
5. Family and patient consent to the trial by signing a consent to be given the drug.
At the start of the injection, the patient will be given a dose of 100 mg. After that, the dose will be increased gradually to 250 mg. The technique of giving is by injection.
(Mar)
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