Trial of potential Covid-19 treatment begins in SA
Scientists will determine if the anti-diarrhoea drug nitazoxanide improves outcomes in high-risk patients
Scientists at Cape Town’s Groote Schuur Hospital have begun enrolling volunteers in a phase 3 trial investigating the potential of the drug nitazoxanide to treat Covid-19.
It is one of several drugs scientists hope to repurpose for treating patients infected with Sars-Cov-2, the virus that causes Covid-19.
Nitazoxanide was discovered in the 1980s and is no longer under patent. It is licensed in many countries for treating diarrhoea caused by parasitic infections, but is not sold in SA.
“The two major unanswered questions in the Covid-19 field are can we find an effective antiviral that improves outcomes, and what is the timing of giving such a treatment,” said principal investigator Keertan Dheda, head of pulmonology at Groote Schuur Hospital and the University of Cape Town. The trial will determine whether Covid-19 patients who receive nitazoxanide are less likely to progress to severe illness.
“This is the only nitazoxanide trial globally in ambulatory patients that is being performed in a resource-poor setting and that will be able to evaluate efficacy in HIV-infected persons,” he said.
SA has the world’s highest HIV burden, with more than 7.7-million people living with the disease, and a well-established Covid-19 epidemic. While the rate of new Covid-19 infections appears to have slowed, SA is still recording large numbers of cases and has strong clinical trial research infrastructure, making it an ideal place to study the disease.
The randomised controlled trial aims to enrol 900 adult volunteers at four sites in SA who have recently been diagnosed with Covid-19, are not in hospital, and are at higher risk of severe illness, including people with HIV. Half the participants will receive nitazoxanide and half will receive a placebo, but neither they nor the scientists will know who has received which treatment until the trial is completed. The participants will have to test positive with a Covid-19 PCR test, and will receive treatment within five days of symptom onset. There are two trial sites in Gauteng — at the Aurum Institute and the Perinatal HIV Research Unit at Wits University — and at the University of KwaZulu-Natal.
Nitazoxanide has already been investigated for treating several other viral diseases, including hepatitis B and hepatitis C, and has been shown to shorten the duration of influenza when given early in the disease, said Dheda.
The R25m trial is co-funded by the SA Medical Research Council (MRC) and Xylomed Pharmaceuticals. The MRC is putting R15m into the study, which has been approved by the SA Health Products Regulatory Authority, said the MRC’s executive manager for strategic research initiatives Niresh Bhagwandin.
Dheda said the trial results were expected in the next three to four months, and Xylomed had agreed to make the drug available in SA if it was successful.
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