The four treatments tested against Covid-19 are ineffective according to the solidarity trial conducted by the World Health Organization (WHO).
Coronavirus
To deal with the Covid-19 pandemic, we needed quick answers. Answers that we did not have. From then on, the scientific community got to work. Some meds were approved under the argument of urgency. It was not an acceptable position whether from a scientific or ethical point of view. In fact, this may have made it difficult to recruit patients for some clinical trials. Serious scientists did not rush to conclusions. They kept their heads over their shoulders as it takes time to know if a new disease is being treated properly.
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Today we know that the four antiviral drugs repurposed to fight Covid-19 are ineffective. They offer no additional benefit compared to placebo plus standard care. It’s a disappointment, but at least now we know and as a result, we can start looking for something else and put this behind us.
A large Trial
The drugs investigated were Remdesivir, Lopinavir, interferon Beta-1A, and hydroxychloroquine. This was a randomized, Phase 3 trial, where the medications were compared with a placebo plus standard therapy. This was conducted simultaneously in up to 405 hospitals worldwide on more than 11,200 patients. The study is currently in the pre-publication phase. To ensure the reliability of the results, we must wait for publication, which is already planned in the New England Journal of Medicine.
Remdesivir was administered intravenously for 9 days at a dose of 100 mg per day, except on the first day when a dose load of 200 mg was injected. Hydroxychloroquine was administered orally as 1,240 mg on the first day and then 620 mg per day for 10 days.
In the study patients were given 400 mg of Lopinavir, per day for 14 days with 50 mg of ritonavir, to counteract the harmful effects of Lopinavir on the liver.
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Interferon Beta-1A was administered subcutaneously in a dose of 132 micrograms for 6 days (3 administrations of 44 micrograms each). The criteria used to evaluate the efficacy of the treatments were mortality after 28 days, the need for ventilation, and the length of hospital stay.
Disappointing but reliable results
The authors’ conclusion is undeniable: “The most important parameters of mortality, ventilation needs, and length of hospital stay were not significantly reduced by any of the drugs in the study”. With such a large sample size, these seem to be the most robust results available to date. In fact, the larger the sample size, the more likely it is to detect smaller but potentially life-saving effects at the population level.
Now, global medical research will be able to open a new chapter on these four treatments. It will focus on other therapeutic approaches until a vaccine is developed. The few doctors who are advocates for hydroxychloroquine and who continue to prescribe it as a treatment for COVID-19 are now doing so against the scientific evidence at our disposal.
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References
Remdesivir and interferon fall flat in WHO’s megastudy of COVID-19 treatments
Trial of Treatments for COVID-19 in Hospitalized Adults (DisCoVeRy)
FEEDBACK:
In fact these results are far from reliable. The 4 large RCT’s on HCQ, RECOVERY in England, NIH’s ORCHID in the U.S., DisCoVeRy in France, and SOLIDARITY by WHO, were supposed to finally settle the question of HCQ’s effectiveness. However, the RECOVERY trial was found to have presented the data in such a way that it obscured the fact that HCQ was just as effective as the much-lauded dexamethasone for ventilated patients, despite being labeled as “no-benefit”. Now we find that the DisCoVeRy trial terminated the study early as of “no benefit”, when the data showed a 17% benefit of HCQ over the controls. And in WHO’s SOLIDARITY trial it was revealed that some “controls” (so-called) received HCQ so “adjustments” had to be made to the data.
After the “Lancetgate” episode you would think the data would be released as soon as possible after these studies ended. But instead, months after the conclusions of the ORCHID, DisCoVeRy, and SOLIDARITY trials, the data still has not been released for pubic view and public review. The logical conclusion to draw is there are serious flaws with the studies that affect the validity of the conclusion of HCQ having “no benefit”. At this point, it should be demanded of these RCT’s that they release their data to the public, even if in preprint form. And not just the “adjusted” data, but the raw data.