Professional Documents
Culture Documents
underway to find an effective treatment for Covid-19, has halted testing malaria drug
hydroxychloroquine, after data showed that the drug does not result in the reduction of
mortality of hospitalised COVID-19 patients, when compared with standard of care.
Addressing the WHO briefing in Geneva, Dr Ana Maria Henao Restrepo, who heads the
research and development blueprint, said that the decision was taken to stop the
hydroxychloroquine arm of the Solidarity Trial based on the evidence from a study published
by a trial conducted in the United Kingdom, and the preliminary data from the Solidarity
trial, including the French discovery trial data.
The trial’s Executive Group and principal investigators made the decision based on evidence
from the Solidarity trial, UK’s Recovery trial, and a Cochrane review of other evidence on
hydroxychloroquine, the WHO official said.
Significantly, in May, WHO had temporarily had stopped that hydroxychloroquine arm
of its Solidarity trial. Wednesday’s WHO decision also comes just two days after the US
Food and Drug Administration on Monday revoked its emergency use authorization for the
drugs hydroxychloroquine and chloroquine for treatment of Covid-19.
“We took three actions. First, was to conduct a systematic review of the evidence. Second,
was that we looked at the safety of hydroxychloroquine, among the patients who were treated
in the Solidarity trial and Discovery trial in France. Third, we promised that we will look into
evidence though our data safety monitoring committee. After completing these steps, we had
communication with our executive group that is formed by our representatives of seven
member states, who are participating in the trial,” Dr Restrepo said.
“And today, we finalised, after we called all the investigators in the trial. On the basis of the
evidence that is available to investigators, secretariat and the executive group – a decision
was made to stop the randomisation with the hydroxychloroquine trial on the basis of two
pieces of information. First, the data that was published by UK trial, and second, the data that
was available to us from the solidarity trial,” Dr Restrepo said.