Deborah SeahDecember 17, 2021
Tag: COVID-19 , Molnupiravir , Dexamethasone
At the point of writing the COVID-19 pandemic is nearing its two-year run with more than four million deaths and a total of 219 million cases worldwide. Scientists across the world are still scrambling to better understand this virus that struck the world in the beginning of the year 2020. Vaccination against COVID-19 has been the focus of many governments since the approval and manufacture of new COVID-19 vaccines in early 2021. Treatments however are still being worked on and developed to finetune the right cocktail of medications to treat patients with COVID-19. Given the range of symptoms, the patient’s age, as well as underlying health condition, COVID-19 patients can experience different severities of symptoms. Most COVID-19 patients with mild symptoms are able to recover at home without having to be admitted to the hospital. For such patients it is usually recommended for them to be quarantined for 14 days depending on the measures set by the government. To help ease the symptoms of COVID-19 patients should try to get enough rest, stay well hydrated, and take medications to relieve fever, aches, and pains as prescribed by a medical doctor.
Based on the World Health Organization (WHO) close to 80% of COVID-19 patients usually recover from the disease without the need for hospital treatment. Unfortunately for the remaining 20% it is a different story. Out of those with COVID-19 15% become seriously ill and would require respiratory support from oxygen tanks. The remaining 5% who are critically ill will need intensive care. Those who are of higher risk of severe disease require more advanced respiratory support such as ventilation. Currently treatment of COVID-19 has been to counter the symptoms or to help reduce the severity of the symptoms. But there is light at the end of the tunnel as the research and development of a COVID-19 treatment is underway and some promising results from various trials have shown that a treatment is not far behind. The following will discuss the treatments that have been studied to curb the progression of COVID-19 in people. And if you want to know more about COVID-19 and other pharma information, Pharmasource would be your best choice.
Early October 2021, MSD also known as Merck in the United States (U.S.) and Canada together with Ridgeback Biotherapeutics announced promising interim results from its Phase 3 trial for molnupiravir, an investigational oral antiviral medicine. From the analysis it was found that administering molnupiravir to patients significantly reduced the risk of hospitalization or death.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global efforts to fight the pandemic and will add to MSD’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most. Consistent with MSD’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible,” said Robert M. Davis, chief executive officer and president, MSD.
After the release of the interim analysis of the Phase 3 trial, MSD announced on October 11, 2021 that it has submitted an application for Emergency Use Authorization (EUS) to the U.S. Food and Drug Administration (FDA) for molnupiravir for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. Agreements have also been drawn between countries such as Singapore and the U.S. for the supply of molnupiravir if it is authorized or approved for use.
Traditionally used to treat a wide range of conditions due to its anti-inflammatory and immuno-suppressant effects, dexamethasone is a corticosteroid that was found to benefit critically ill COVID-19 patients. Dexamethasone was tested in the United Kingdom’s national clinical trial called RECOVERY. Results from the trial demonstrated a lower mortality among the patients who were administered dexamethasone.
According to the WHO, COVID-19 patients who need oxygen ventilators showed reduced mortality by about one third after treatment with dexamethasone. For patients who only require oxygen support the mortality was reduced by one fifth. Based on the WHO recommendations such corticosteroids should be given orally or intravenously for the treatment of patients with severe and critical COVID-19. On top of that, for patients with less severe COVID-19 WHO recommends against the use of dexamethasone or other corticosteroids for treatment.
Remdesivir is a nucleotide analog invented by Gilead Sciences, Inc. It has broad-spectrum antiviral activity in both in vitro and in vivo demonstrated in animal models against multiple emerging viral pathogens.
On November 20, 2020 the WHO issued a conditional recommendation for the use of remdesivir in hospitalized patients with COVID-19, regardless of disease severity. This was announced as a result of data reviewed by a panel of professionals from the WHO Solidarity Trial as well as three other randomized controlled trials consisting of data from over 7000 patients.
Remdesivir has been approved or authorized for temporary use as a COVID-19 treatment in almost 50 countries worldwide. There are also multiple ongoing international Phase 3 clinical trials to evaluate the safety and efficacy of Remdesivir for the treatment of COVID-19, in different patient populations, formulations, as well as combinations with other therapies.
Tocilizumab is an intravenous anti-inflammatory monoclonal antibody used to treat rheumatoid arthritis. It is manufactured by Swiss drugmaker, Roche.
FDA issued an emergency use authorization (EUA) for Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients 2 years of age and older with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is not authorized for use in outpatients with COVID-19.
In clinical trials of hospitalized patients with COVID-19, tocilizumab in addition to routine care, which included corticosteroids, was shown to reduce the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalized. The risk of patients being placed on ventilators through 28 days of follow-up was also decreased.
Convalescent plasma is blood plasma from a person who has recovered from an infection. It contains antibodies against the infection such as SARS-CoV-2 and may help a patient with COVID-19 recover faster. It is sometimes used to complement initial treatments with steroids and antiviral medications.
Despite some evidence of its effectiveness in treating patients with COVID-19, studies have shown that it does not reduce the risk of intubation or death in hospitalized patients with COVID-19.
https://www.who.int/news-room/q-a-detail/coronavirus-disease-covid-19
https://www.msd.com/news/msd-and-ridgebacks-investigational-oral-antiviral-molnupiravir-reduced-the-risk-of-hospitalization-or-death-by-approximately-50-percent-compared-to-placebo-for-patients-with-mild-or-moderate/
https://www.msd.com/news/msd-and-ridgeback-announce-submission-of-emergency-use-authorization-application-to-the-u-s-fda-for-molnupiravir-an-investigational-oral-antiviral-medicine-for-the-treatment-of-mild-to-moderate-covid/
https://www.channelnewsasia.com/singapore/covid-19-treatment-antiviral-drug-pill-molnupiravir-msd-merck-2224961
https://www.who.int/news-room/q-a-detail/coronavirus-disease-covid-19-dexamethasone
https://www.nejm.org/doi/full/10.1056/nejmoa2021436
https://www.gilead.com/purpose/advancing-global-health/covid-19/about-veklury
https://www.uptodate.com/contents/tocilizumab-drug-information?source=see_link
https://www.nature.com/articles/s41591-021-01488-2
Deborah Seah, Science Writer
Deborah Seah is a contributing writer for a column on PharmaSources.com, Discovering Biotechnology. The column explores innovative technologies in the world of biotech and evaluates its impact on our future. She is also an editor for a monthly science and technology magazine, Asia-Pacific Biotech News.
Prior to her career in writing she worked as a research associate at a plant genetics laboratory of a multinational agriculture company. Following that she also had experience in a medical diagnostics start-up as a medical technologist.
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