Friday, September 03, 2021

Much-touted Bangladesh study of masks is a snark

Multiple accounts have popped up (e.g. here) saying that the study vindicates mask-wearing. It does not. Just two quotes from the study abstract tell the tale:

"Neither participants nor field staff were blinded to intervention assignment"

"The proportion of individuals with COVID-like symptoms was 7.62% (N=13,273) in the intervention arm and 8.62% (N=13,893) in the control arm"

For a start, the study was of people with "COVID-like symptoms", not actual disease and there was NO data on deaths. So there is a lot of room for slippage there. How often were the "symptoms" actually indicative of COVID infection?

Secondly, the figures for mask-wearers and non-mask-wearers differed only slightly (7.62% vs 8.62%) -- to a degree readily explainable by the fact that the study was not blinded. The experimenters knew who the wearers and non-wearers were and it is routine that such a circumstance gives results favourable to the hypothesis.

Not blinding the study was a huge breach of scientific protocol and renders the results of zero authority.


1st Patient Begins Pfizer’s Oral COVID-19 Drug Trial

The first patient in a clinical trial analyzing Pfizer’s oral COVID-19 drug has received the first dose of the medication, the company announced on Sept. 1.

The study is analyzing a protease inhibitor known as PF-07321332. The drug is meant to combat COVID-19 in patients who experience symptoms from the disease, but don’t require hospital care.

The randomized, double-blind trial will enroll about 1,140 participants, approximately half of whom will receive a placebo. The participants will receive the drug or the placebo every 12 hours orally for five days.

People who are given the drug will also receive ritonavir.

“If successful, we believe this therapy could help reduce severity of illness among a broad population of patients,” Rod MacKenzie, Pfizer’s chief development officer, said in a statement.

The company has already begun a separate trial that’s testing a different protease inhibitor, this one administered via IV.

Inhibitors are a type of medication that stops viruses from replicating.

Antiviral pills against COVID-19 have yet to be developed. The IV-administered remdesivir, produced by Gilead Sciences, was approved by U.S. drug regulators in 2020.

Other companies are also attempting to produce the medicines, including Merck and Roche.

Merck has already begun a late-stage trial analyzing its pill candidate, dubbed molnupiravir. Interim results from a phase two trial for Roche’s pill, AT-527, have shown promising results, Roche and its partner Atea Pharmaceuticals stated in July.

Pfizer said that if its trial shows PF-07321332 is safe and effective, it could ask regulators for authorization in the fourth quarter of 2021.


The developer of ivermectin is performing late-stage trials on a drug that could actually prevent COVID-19

Merck & Co partnered with Ridgeback Biotherapeutics to develop molnupiravir.

Enrollment for late-stage trials for their drug have already started.

The companies hope the drug could prevent COVID-19 infection in patients, but have yet to share further detail of how exactly it will be used.

Merck is also the developer of ivermectin, an anti-parasite drug that has gained infamy due to false claims that it could combat the virus - which is the real use for molnupiravir.

Molnupiravir could fill the role that many are currently incorrectly using ivermectin for.

A study by the University of North Carolina at Chapel Hill found that the drug could prevent replication of viral cells of COVID-19 and other similar viruses.

The drug, which can be taken via a pill, is now entering late stage trials in the United States as Merck plans to eventually seek FDA approval.

Over 1,300 volunteers aged 18 or older will be recruited for the study and live in a house with someone who has a symptomatic case of the COVID-19.

Merck also plans to use the drug in some lower income countries in the meanwhile, attempting to acquire emergency authorization.

The company has partnered with Indian generic drug manufacturers to produce and sell versions of molnupiravir in the country, pending approval from local regulators.

Merck hopes the drug could help alleviate these countries COVID-19 situations while they await a larger supply of the vaccine. '

Only around 36 percent of Indians have received at least one shot of the virus, and less than 11 percent are fully vaccinated.




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