Remdesivir clinical trial being reviewed by PHA board

NASSAU, BAHAMAS — The Bahamas is still awaiting the first order of the drug Remdesivir to arrive in-country, in order to begin clinical trials with positive coronavirus (COVID-19) cases.

In a recent interview with Eyewitness News, National HIV/AIDS and Infectious Disease Programme Director Dr Nikkiah Forbes explained that before the trial can proceed, a study profile/proposal has to be approved by the institutional review board at the Public Hospitals Authority and an ethics board.

She noted that the study profile will detail how the trial will be conducted and how people will be recruited.

She assured that the trial will be based on ethical parameters, the patient’s right to participate, and will keep with the best quality standards.

“So the next step after there is a protocol for proposal and it’s been discussed with potential researchers is that the protocol has to be reviewed by an ethics board or an institutional review board in-country,” Forbes said.

“That has been put to the institutional review board at the PHA and an ethics board associated with COVID-19 in The Bahamas preceded that and the trial cannot participate without full ethical approval.”

“…But even after that for anyone to participate, people have to give their full informed consent to participate and agree to participate.”

Forbes could not indicate exactly how much of the product had been ordered in the first instance for the trail.

“We extrapolated for a number of patients based upon the current trends we were seeing,” she said.

“When we do administer it, it will be in keeping with the strict protocols in the WHO solidarity trial.”

In May, the US National Institute of Allergy and Infectious Diseases (NIAID) revealed that hospitalized patients with advanced COVID-19 and lung involvement who received Remdesivir recovered faster than similar patients who received a placebo.

The preliminary data analysis was based on a randomized, controlled trial involving 1063 patients, which began on February 21.

The trial showed that patients on the drug, made by Gilead Sciences Inc., had a 31 percent faster time to recovery than those on a placebo.

Remdesivir has become the first drug to show a clear-cut effect in treating the respiratory illness.

Gilead Sciences, Inc. has also announced topline results from the open-label, Phase 3 SIMPLE trial evaluating five-day and ten-day dosing durations of the investigational antiviral Remdesivir in hospitalized patients with severe manifestations of COVID-19.

The study demonstrated that patients receiving a 10-day treatment course of Remdesivir achieved similar improvement in clinical status compared with those taking a five-day treatment course.

In May, Gilead Sciences secured emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for Remdesivir to treat COVID-19 infection.

The authorization allows broader access to the drug for treating hospitalized patients with severe symptoms across the U.S.

The company has also signed non-exclusive licensing agreements with at least five generic manufacturers to expand access to the experimental antiviral drug.

The licensees include Mylan, Cipla, Hetero Labs and Jubilant Life Sciences in India, as well as Ferozsons Laboratories in Pakistan, which will be able to manufacture and distribute Remdesivir in 127 countries.

The drug will be made available in low, lower-middle, upper-middle, and high-income countries, including India, Pakistan, Afghanistan, North Korea and South Africa.

The licensees are able to set their own prices for the generic version they manufacture.