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What We Know About Potential Treatments for COVID-19

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Unread 03.23.20, 08:40 PM
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What We Know About Potential Treatments for COVID-19

On 03.23.20 09:30 AM posted by Kevin Pham

The rapid spread of the coronavirus has completely upendeddaily life for all Americans and shows no sign of letting up.

Harsh orders from numerous state governors require Americansto stay home except for essential activities in an effort to halt, or at leastslow, new cases of COVID-19, the disease caused by the new coronavirus.

These indefinite shelter-in-place orders leave manyAmericans wondering if relief will ever come.

We have seen several glimmers of hope, however, particularlyin the realm of pharmaceuticals, although these treatments are far from certainand will take time to become available.

The first of these is a vaccineagainst COVID-19, which is in phase one trials. Considering that COVID-19first reached America in mid-January and the vaccine is in trials by mid-March,this approval process has been moving at breakneck speed.

Even so, this vaccine is expected to take at least one yearbefore it can pass all three phases and be used by the general population.

Another promising development is a new drug called remdesivir,developed by Gilead Sciences. It is currently in phasetwo clinical trials in Nebraska that began late in February, and two phasethree trials in Asia that began early in March.

This is only the beginning, though, and the first studyenrollee has not yet completed the test protocol in the phase two trial; thephase three trials only have begun to recruit participants. The phase two trialwill involve close to 400 enrollees, and the phase three trials together willinvolve close to 1,000 enrollees.

These processes may take anywhere from several months toseveral years. Given the importance of finding a cure for COVID-19, the effortprobably will be accelerated as much as possible. But there is a limit to howfast these trials may proceed.

These trials are intended to show the efficacy of the drugand therefore require a large number of participants, half of whom will receiveeither a placebo (phase two study) or receive the standard of care (phase threestudies) rather than remdesivir.

These measures will ensure that any improvement due to thedrug is not a fluke.

Drug trials must pass through three phases before they canbe marketed. In phase one, healthy volunteers are given the drug to monitor foradverse reactions. If a drug is unsafe for a healthy individual, it could causeimmense harm in a sick individual for whom the drug was intended in the firstplace.

Drugs that pass phase one trials are shown to be relativelysafe and undergo phase two trials to show efficacy against the illness they areintended to treat. Phase three trials introduce many more participants and are intendedto show whether the drug is more efficacious than existing treatments.

A fourth phase occurs after a drug is available to thepublic and includes postmarket surveillance for adverse effects.

The process is long and time consuming because it needs tobe. Especially for a disease such as COVID-19, a drug must be safe, it mustwork, and it must work better than what doctors already are doing. If not forthose three attributes, the new drug only would hurt the patients it wasintended to help.

The good news is that hydroxychloroquine and azithromycinhave gotten through these trials for other diseases, so they are available fordoctors to prescribe.

There are no drugs that are approved to treat COVID-19, but drugsapproved for other diseases may be prescribed for off-label use.

So why haven’t doctors around the world begun ordering thesedrugs for all COVID-19 patients?

The first reason is that there is a shortageof the drug.

Plaquenil, the brand name of hydroxychloroquine, commonly isused to treat rheumatoid arthritis and lupus. As soon as news broke that itmight be effective for treating COVID-19, medical demand for the drug quicklydepleted pharmacy supplies, depriving patients of their needed medication.

In response, manufacturersare ramping up production to meet the potential need if hydroxychloroquineproves effective against COVID-19.

Also, as is true of all drugs, hydroxychloroquine is notbenign; it can cause a heart condition that increases the chance of a deadlyarrhythmia.

Another reason is that the evidence, though promising, isminimal.

The buzz that these drugs have generated is due in largepart to a Frenchstudy that showed that patients treated with the combination ofhydroxychloroquine and azithromycin recovered faster and more completelycompared to patients who were not treated with these drugs.

This sounds promising, but the study involved only 36patients, of whom 20 were given these drugs and 16 acted as a control group whodid not receive the drugs. By comparison, this study population is about one-tenththe size of the Gilead phase two study population, which will include 400participants.

Furthermore, the French study excluded patients who werelater admitted to the intensive care unit, so it says nothing about whetherthese drugs will help with severe illness. In fact, it may suggest that thedrugs were unable to prevent disease progression in those patients.

One of the truly promising aspects of this study is that itmeasured viral loads and found that patients who completed the test protocolwith the hydroxychloroquine and azithromycin combination were virologicallycured—that is, they had no detectable viral RNA. This is important because aperson infected with COVID-19 still may be sheddingviruses up to 37 days after developing the disease.

At Day Six of the study, 100% of the patients treated withthe combination of hydroxychloroquine and azithromycin had undetectable viralloads, compared to 12.5% of patients in the control group.

One patient who was treated only with hydroxychloroquinestill had detectable viral loads on Day Six; she was given azithromycin on Day Nine,which cleared her infection. However, a different patient initially treatedwith the combination tested positive again on Day Eight.

Clearly, the study leaves many questions to answer and islacking in rigor, at least compared to a three-phase drug approval process, butit does show promise. Enough promise that New York state will begin a largetrial Tuesday.

For now, hydroxychloroquine with azithromycin; remdesivir; anda vaccine are all pharmaceutical therapies in the works for the fight againstCOVID-19.

Although none of these is guaranteed to work, each representsa small ray of hope, a reason for cautious and guarded optimism, for a returnto normal life.

The post What We Know About Potential Treatments for COVID-19 appeared first on The Daily Signal.

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