What makes the SAIVE study so good?
Professor Colleen Aldous is a research professor at the School of Clinical Medicine at the University of Kwazulu-Natal in South Africa. She recently described the SAIVE trial of prophylactic ivermectin for covid-19 as the “best quality RCT we have yet seen published on ivermectin”. IMI spoke to her to find out more.
Professor Aldous has frequently advocated the use of ivermectin for the treatment and prophylaxis of SARS-CoV-2 infection (covid-19) and has worked closely with front-line physicians in this field. The SAIVE trial evaluated the effectiveness of ivermectin for prevention of covid-19. She identifies several important features of SAIVE:
- There are 200 participants in each arm of the study
- The study is randomised, double-blind and placebo-controlled
- The medication in the placebo arm was matched to that in the intervention arm (which does not always happen)
- The study included only non-vaccinated participants – it was conducted in Bulgaria which has a low vaccination rate
- The participants had been exposed to a person with PCR-confirmed SARS-CoV-2 infection
In fact, “they took a lot of trouble to make sure that …… the participants had been exposed to the virus”, says Professor Aldous. Crucially, the company (Medincell) also established an independent US-based Data Monitoring Committee to oversee the trial. “For those people who are cynical about a company doing their own trial because there’s a conflict of interest ….. I think that the conflict of interest has been addressed with that”, she says.
The dosing of ivermectin – 200 micrograms per kilogram on the first day and 100 micrograms per kilogram for the next 27 days – was designed to emulate the slow-release injectable product that Medincell is developing. The medication was started after a participant had been exposed to a sick person. They were then monitored to see how many participants developed laboratory -confirmed SARS-CoV-2 infection.
The results showed that there was a 72 per cent reduction in infections in participants who received ivermectin. Professor Aldous notes that the results have only been published in a press-release so far and there has, as yet, been no academic publication of the trial. Therefore, many questions remain. She would like to know “at what date after they started taking the regimen did they start showing symptoms; when were they PCR-positive; if they were symptomatic, how long were they symptomatic”. Also, she is curious to find out what happened to the single participant who did not complete the placebo arm. “I’d like to know if they just went and got treatment because they weren’t feeling well”, she says. “There are lots of questions that will be answered when this paper comes out and I’m really looking forward to that”, she adds.