John H. Beigel, et al., for the ACTT-1 Study Group Members*
Remdesivir was given on compassionate grounds to 61 patients; 53 patients were available for evaluation, 22 in US, 22 in Europe or Canada, and 9 in Japan. At baseline, 30 patients were receiving mechanical ventilation and 4 were receiving ECM oxygen.
Conclusion: clinical improvement was observed in 36 of 53 patients (68%).
Remdesivir in adults with severe COVID-19: randomized, double-blind, placebo-controlled, multicenter trial (The Lancet, May 16, 2020)
Yeming Wang MD; Dingyu Zhang MD; Prof. Guanhua Du PhD; et al.
The study was conducted at ten hospitals in Hubei, China. Between Feb 6, 2020 and March 12, 2020, 237 patients were enrolled and randomly assigned; 158 to Remdesivir and 79 to placebo.
Conclusion: In this study, Remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies.
SOLIDARITY Trial (on going)
The WHO has announced that Thailand will join a multi-country study for potential treatments for COVID-19. In addition to Thailand, the Solidarity Trial includes participation of Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain and Switzerland.
The SOLIDARITY Trial was designed to test four different drugs or combinations – Remdesivir, combination of lopinavir + ritonavir, the two drugs + interferon beta, and chloroquine – and would compare their effectiveness to what is called standard of care – the regular support hospitals are giving to COVID19 patients now.
As of 19 June 2020, the trial arm evaluating hydroxychloroquine has been suspended. To date, three therapeutics are approved to treat COVID19; dexamethasone in UK; favilavir in China, Italy and Russia; and Remdesivir in US and Japan.
Medscape Report – updated June 22, 2020
Author: David J. Cennimo, MD, FAAP, FACP, AAHIVs [Italics are mine]
The antiviral drug Remdesivir gained emergency use authorization from USFDA on May 1, 2020, based on preliminary data showing a faster time to recovery of hospitalized patients with severe disease.
Numerous other antiviral agents, immunotherapies, and vaccines continue to be investigated and developed as potential therapies.
All infected patients should receive supportive care to help alleviate symptoms. Vital organ function should be supported in severe cases.
No vaccine is currently available for SARS-CoV-2. Avoidance is the principal method of deterrence.
Numerous collaborative efforts to discover and evaluate effectiveness of antivirals, immunotherapies, monoclonal antibodies, and vaccines have rapidly emerged. Searching for effective therapies for COVID-19 infection is a complex process, however.
How these potential COVID-19 treatments will translate to human use and efficacy is not easily or quickly understood.
The WHO has embarked on an ambitious global "megatrial" called SOLIDARITY in which confirmed cases of COVD-19 are randomized to standard care or one of four active treatment arms (remdesivir, chloroquine or hydroxychloroquine [since paused [146] ] lopinavir/ritonavir, or lopinavir/ritonavir plus interferon beta-1a). [147]
The urgent need for treatments during a pandemic can confound the interpretation of resulting outcomes of a therapy if data are not carefully collected and controlled. Andre Kalil, MD, MPH, writes of the detriment of drugs used as a single-group intervention without a concurrent control group that ultimately lead to no definitive conclusion of efficacy or safety.
Rome and Avorn write about unintended consequences of allowing widening access to experimental therapies. First, efficacy is unknown and may be negligible, but, without appropriate studies, physicians will not have evidence on which to base judgement. In addition, demand for unproven therapies can cause shortages of medications that are approved and indicated for other diseases, thereby leaving patients who rely on these drugs for chronic conditions without effective therapies.
It is difficult to carefully evaluate the onslaught of information that has emerged regarding potential COVID-19 therapies within a few months’ time in early 2020. A brief but detailed approach regarding how to evaluate resulting evidence of a study has been presented by F. Perry Wilson, MD, MSCE. By using the example of a case series of patients given hydroxychloroquine plus azithromycin, he provides clinicians with a quick review of critical analyses.
SUM UP
Whatever information is available till date is insufficient to make educated, evidence-based decisions. The currently employed therapies are still experimental and must be used with caution and under strict medical supervision. Creating Hype around one therapy after another is a serious disservice to public and must be discouraged and actively curbed.
Concluded.
https://www.nejm.org/doi/full/10.1056/NEJMoa2007764
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext
https://en.wikipedia.org/wiki/Remdesivir
https://www.who.int/thailand/news/detail/20-03-2020-thailand-joins-the-who-solidarity-trial-global-testing-of-effective-treatments-of-covid-19-across-8-countries-an-aggressive-effort-to-save-lives-from-the-pandemic#:~:text=The%20World%20Health%20Organization%20has,%2C%20Spain%20and%20Switzerland.
https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-therapeutics-tracker
https://emedicine.medscape.com/article/2500114-treatment#d1
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