In a study, linked here, a Brazilian institute says that hydroxychloroquine associated with azithromycin is associated with reduced hospitalization rate when given quickly to people showing symptoms of Covid-19.
How serious and trustworthy is that study?
The Food and Drug Administration is warning against the use of two drugs President Donald Trump has repeatedly touted as a possible "game changer" in the fight against the coronavirus.
The Drug Safety Communication published Friday said the agency cautions against the use of hydroxychloroquine or chloroquine for COVID-19 treatment outside of hospitals or clinical trials due to the risk of heart rhythm problems.
"Hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19," the FDA warned. Both can cause abnormal heart rhythms and a dangerously rapid heart rate, the statement said.
The FDA explicitly warned consumers not buy the drugs from online pharmacies without a prescription from a health care professional. "Consumers should not take any form of chloroquine that has not been prescribed for them by a healthcare professional," the agency stated on its website.
A clinical trial in Brazil testing a high dose of chloroquine to treat hospitalized COVID-19 patients was halted after a spike in deaths among patients who received the drug.
The Brazilian trial, published on Friday in the Journal of the American Medical Association Network Open, added to a pile of confusing evidence around using the antimalarial pills chloroquine and hydroxychloroquine for coronavirus patients.
There's no high-quality evidence showing the medicines help patients with COVID-19, the disease caused by the coronavirus. The US Food and Drug Administration said Friday these drugs should be used only in clinical trials or at hospital because of safety risks to patients. The National Institutes of Health has advised caution in prescribing them.
New York Gov. Andrew Cuomo said Thursday night that a review of medical records by researchers at the State University of New York at Albany showed that the drug "didn't really have much of an effect on the recovery rate."
That conclusion came from a preliminary look at an observational study of about 600 people. Data from the study hasn't been published or reviewed by outside scientists, but Cuomo provided the information at a CNN town hall broadcast. Cuomo's office didn't immediately respond to requests for comment.
David Holtgrave, the dean of the Albany university's School of Public Health and lead researcher on this study, said he hoped to complete the analyses next week and would release detailed results in a peer-reviewed manner as quickly as possible.
The peer-reviewed version of the Pagliaro et al. preprint mentioned by the OP is here and appears to have been published in September 2020.
This meta-analysis (Cochrane review, published February 2021) doesn't include the Pagliaro et al. study but the authors (Singh et al., lead author is from the University of Liverpool) says the following on the need for hospitalisation specifically:
Evidence for prevention of hospital admission in outpatients with COVID‐19 is very uncertain. However, given the lack of benefit in hospitalized patients, and limited available evidence suggesting little or no effect on clearance of the virus from the respiratory tract, benefit from treatment of outpatients appears unlikely.
Their more general headline conclusions are (and they refer to mechanical ventilation, so not entirely unrelated to OP's question):
HCQ for people infected with COVID‐19 has little or no effect on the risk of death and probably no effect on progression to mechanical ventilation. Adverse events are tripled compared to placebo, but very few serious adverse events were found. No further trials of hydroxychloroquine or chloroquine for treatment should be carried out.
These results make it less likely that the drug is effective in protecting people from infection, although this is not excluded entirely.
In terms of implications for research, they say:
No further trials in hospital inpatients are justified.
The evidence is less certain for ambulatory treatment of people with mild COVID‐19, and for prevention of COVID‐19 in people with, or at risk of, exposure to SARS‐CoV‐2.
Edit re. azithromycin (as per OP) Singh et al. say that "[a] higher risk of adverse events was reported in the HCQ‐and‐azithromycin arm" of the study they considered, and..
Compared with usual care in one study in 444 people, hydroxychloroquine given with azithromycin (an antibiotic) made no difference to:
· how many people died;
· how many needed mechanical ventilation; or
· time spent in hospital.
