A randomized, controlled trial is the gold standard of clinical research. But pulling one together for Covid-19 is complicated by the realities of working in hospital systems overwhelmed by the sheer size of the outbreak. One of the biggest issues is ensuring the same standard of care in every place where the drug is being tested.
Two trials will test the efficacy of remdesivir, an experimental antiviral produced by American drugmaker Gilead. It works by blocking the enzyme that many viruses use to replicate inside human cells. It has not yet been approved for any use, but it does appear to be safe, according to the results of a 2018 clinical trial of Ebola patients in the Democratic Republic of the Congo. Though this will be its first test against coronaviruses in humans, scientists in China recently reported that remdesivir proved effective at preventing SARS-CoV-2 ( the virus that causes Covid-19 ) from infecting primate cells.
In addition to remdesivir, researchers have begun dosing patients in another trial, testing antiviral drugs lopinavir and ritonavir, which have been approved for HIV and come in generic formulations. These drugs also impede viruses by blocking an enzyme they use to replicate inside human cells. Soon, trials are expected to begin to test the effectiveness of oseltamivir and arbidol, influenza drugs already approved in China, which flight the flu by preventing its ability to shed copies of itself from the surface of host cells. The trial registry also includes a number of more unconventional—and perhaps dubious—approaches, including hormones, injections of stem cells, and even vitamin C infusions. And unfortunately, in an outbreak, the one thing there’s sure to be no shortage of are patients desperate to try anything.
China has launched a few trials that test chloroquine, a malaria drug that killed off the new coronavirus (recently named SARS-CoV-2) in cell culture. And researchers are studying whether steroids diminish inflammation in people with severe COVID-19, or cause harm.
Another study — a 300-person controlled trial — will test serum from COVID-19 survivors. The bare-bones strategy, based on the idea that the antibodies one person steadily builds up to fight a virus can rapidly help someone freshly infected to fight it off, has had modest success when used to treat other viruses in decades past.
Two stem-cell trials are also listed in China’s registry. In one, a team at the First Affiliated Hospital of Zhejiang University will infuse 28 people with stem cells derived from menstrual blood, and compare results with those from people who did not receive the infusions. To date, there is minimal evidence indicating that stem cells clear coronavirus infections.
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