Sahpra open to clinical trials for the use of Ivermectin to treat Covid-19

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Saphra said it would continue to evaluate any emerging peer reviewed publications or data on the drug as treatment for Covid-19. Picture: iStock/Gallo Images
Saphra said it would continue to evaluate any emerging peer reviewed publications or data on the drug as treatment for Covid-19. Picture: iStock/Gallo Images

NEWS


As controversy swirls around the use of a well-known anti-parasitic drug Ivermectin, commonly used in animals and to treat scabies and head lice in humans, against the Covid-19 coronavirus, the SA Health Products Authority (Sahpra) which had previously taken a hard line against the drug, now says it would welcome and expedite applications for its clinical trials.

Further, the local regulatory authority has said it’s also open to considering enabling access to improved formulations of the drug for human use through a Section 21 authorisation of the Medicines and Related Substances Act – which allows Sahpra to authorise the sale of an unregistered medicine for a certain purpose for a specified period.

“There are currently no applications either for clinical trials or for the registration of Ivermectin for the treatment or as prophylaxis for Covid-19. However, Sahpra encourages and supports all well-designed, ethically approved, scientific studies designed to identify new or existing medicines that are used for the treatment or prophylaxis of Covid-19,” the authority said on Wednesday.

At least one political party, the National Freedom Party (NFP), as well as a collective of scientists and activists who call themselves the Ivermectin Interest Group, have called for the drug to be made available.

In terms of safety and efficacy, there is no evidence to support the use of Ivermectin and we do not have any clinical trial evidence to justify its use.
Saphra

The NFP has gone as far as threatening to take Health Minister Dr Zweli Mkhize to court to demand an urgent meeting with him for the country to begin testing it and using it.

Ivermectin has been gaining traction as a “wonder drug” as some medical experts reportedly have suggested that the drug inhibits viral loads and keeps those with early symptoms of the disease from progressing to the hyper-inflammatory phase.

Read | In-depth: The tangled web of medical device regulation in SA

Just last month, the Sahpra took a hard-line stance on the use of the drug for Covid-19 stating that any attempts by anyone to import the drug – which isn’t registered in the country for human use, only animal – would be unlawful.

“Ivermectin is not indicated or approved by Sahpra for use in humans. There is no confirmatory data on Ivermectin available as yet for its use in the management of Covid-19 infections. In terms of safety and efficacy, there is no evidence to support the use of Ivermectin and we do not have any clinical trial evidence to justify its use,” the regulator had stated on December 22.

But, on Wednesday the regulator said it would continue to evaluate any emerging peer reviewed publications or data on the drug as treatment for Covid-19.

Read: SA medical aids to fund Covid-19 vaccines for broader population

An Essential Medicines List Covid-19 sub-committee published a rapid review last month on the drug stating that the overall quality of the randomised control trials involving Ivermectin were extremely low and the drug was not superior to the placebo in terms of viral load reduction or clinical progression.


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