SOLIDARITY Global Megatrial for Coronavirus (COVID-19) Treatments: What the World Health Organization (WHO) Is Studying – and Not Studying by Jane M. Orient, M.D.
According to an article in Science, the UN’s World Health Organization (WHO) has launched a “global megatrial of the four most promising coronavirus treatments” called SOLIDARITY. It will not be the gold-standard randomized double-blind control trial (RCT) because doctors and patients will know what treatment was received. But patients will be randomly assigned to one of the study drugs that are available at the facility or to “the local standard of care for COVID-19.”
Physicians will record:
- The day the patient left the hospital or died.
- The duration of the hospital stay.
- Whether the patient required oxygen or ventilation.
While not an elaborate design, it could provide useful data. Note that it took several months to design the only RCT conducted during the Ebola outbreak, and the outbreak was over before the RCT could be completed.
Remdesivir was developed to combat Ebola but proved ineffective. It shows antiviral activity against other viruses. It must be given intravenously. Ritonavir/lopinavir (Kaletra®) was approved in 2000 to treat human immunodeficiency virus (HIV). A third arm of the study combines this with interferon-beta. At first, the trial was not going to include chloroquine or hydroxychloroquine, long used for malaria and some autoimmune diseases, but these were added because of widespread interest. They are inexpensive drugs that are given orally and are thus practical for early use in patients who are not very ill – when they are more likely to be effective.
This trial does not include intravenous vitamin C, azithromycin (which some physicians combine with hydroxychloroquine) or the other drugs that have been suggested. Local standard of care may also have important variations.
Electronic Health Records
Requirements for electronic health records (EHRs) were justified by the promise to show “what works” and “what doesn’t.” They could be a powerful research tool if they contain the needed data. Questions they could answer include:
- How important are vitamin D, vitamin C, vitamin A, zinc, selenium or other suggested entities?
- How about determining blood levels?
- Are lipid levels important? (Some have suggested a short course of a statin drug.)
- Do certain antihypertensives (e.g. angiotensin converting enzyme or ACE inhibitors or angiotensin receptor blockers or ARBs) increase or decrease risk of a bad outcome?
- Does ibuprofen increase or decrease risk?
- Do flu shots help or hurt?
A good medical history would contain use of drugs – prescribed, over-the-counter or illicit, all supplements and an immunization history. The EHR presumably charts the hospital course and all interventions. Are our existing powerful statistical tools being used to analyze this wealth of data? If not, why not?
Very few patients are taken to the “altar of truth” these days, yet when performed, autopsies still reveal many diagnoses missed by our advanced technology. We need to preserve body fluid specimens and tissue from lung, liver, kidney, brain and other organs to help answer questions we haven’t thought of yet.
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