Clinical Trials & Research News

Key Prescription Drugs Being Used to Treat COVID-19 Patients

The pharmaceutical industry is focused on developing COVID-19 treatments as the pandemic worsens. Here are the leading prescription drugs being tested as potential cures.

COVID-19 Treatments

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By Samantha McGrail

- As the number of confirmed COVID-19 cases continues to grow, pharmaceutical companies are boosting their efforts to combat the virus. There are currently over 245,000 cases of coronavirus in the US, a number that continues growing exponentially every day.

The Lancet Infectious Diseases estimated that about 0.66 percent of individuals infected with the virus will die. While this number is lower than earlier estimates, it becomes a major challenge when there are currently no approved COVID-19 drug or vaccine treatments. 

The efforts from various pharmaceutical companies to develop a potential COVID-19 drug are extremely important as the pandemic continues to worsen each day. 

FDA Authorizes the Use of Hydroxychloroquine and Chloroquine to Treat COVID-19 Patients

Earlier this week, FDA issued an Emergency Use Authorization (EUA) for the emergency use of oral formulations of chloroquine phosphate and hydroxychloroquine sulfate as COVID-19 treatments. 

READ MORE: Mylan, Pfizer Delay Major Pharmaceutical Merger Due to COVID-19

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Although the anti-malaria drugs are not approved by the FDA, limited clinical data uncovered that chloroquine phosphate and hydroxychloroquine sulfate are currently useful for treatment of hospitalized COVID-19 patients in several countries, the agency stated in a letter to the director of the Biomedical Advanced Research and Development Authority at HHS. 

“FDA is issuing this EUA to facilitate the availability of chloroquine phosphate and hydroxychloroquine sulfate during the COVID-19 pandemic to treat patients for whom a clinical trial is not available, or participation is not feasible,” the letter stated.

As part of the EUA, HHS accepted 30 million doses of hydroxychloroquine sulfate, donated by Sandoz, and chloroquine, donated by Bayer Pharmaceuticals, to distribute to hospitals across the country.  

The drugs are intended to slow the progression of COVID-19 in seriously ill patients and relieve the acute respiratory symptoms in infected patients.

READ MORE: Gilead Expands Access to Potential COVID-19 Treatment, Remdesivir

“President Trump is taking every possible step to protect Americans from the coronavirus and provide them with hope. Scientists in America and around the world have identified multiple potential therapeutics for COVID-19, including chloroquine and hydroxychloroquine,” HHS Secretary Alex Azar said in the HHS press release. 

“The President’s bold leadership and the hard work of FDA and HHS’s Assistant Secretary for Preparedness and Response have succeeded in securing this large donation of medicine. We’ll continue working around the clock to get American patients access to therapeutics that may help them battle COVID-19, while building the evidence to evaluate which options are effective.”

Hydroxychloroquine is one of the most commonly prescribed treatments for COVID-19 patients, according to a new poll from Sermo. The survey of over 6,200 physicians across the world found that the three most commonly prescribed COVID-19 treatments are analgesics, azithromycin, and hydroxychloroquine at 56 percent, 41 percent, and 33 percent, respectively.

Out of 15 options, physicians also chose hydroxychloroquine as the overall most effective therapy for COVID-19.

Former SARS, MERS Drug Could Treat COVID-19 Patients

READ MORE: FDA Accelerates Review of COVID-19 Diagnostic Tests

Antiviral Remdesivir was previously effective in treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), but experts believe it may also be effective against COVID-19.

The drug was originally developed by Gilead Sciences to treat Ebola back in 2013. It showed in vitro and in vivo activity in animal models against the viral pathogens in MERS and SARS, which are structurally similar to COVID-19. For this reason, researchers see remdesivir as a promising COVID-19 drug. 

Remdesivir was first used on a patient earlier this year on the seventh day of illness. The patient showed improvement the following day, and then his symptoms disappeared altogether. 

“What our study showed was that remdesivir essentially mimics one of the natural building blocks of RNA synthesis necessary for genome replication of the virus,” said Bruce Alyward, assistant director-general of the World Health Organization. 

The next step is to wait for clinical trial results, expected at the end of April. 

Most recently, after halting remdesivir production due to overwhelming demand, Gilead has decided to expand access to the drug for patients with the greatest need, according to an official letter from Daniel O’Day, Gilead chairman and CEO.

Expanding access ensures hospitals or physicians can apply for emergency use of remdesivir for severely ill patients. The move will also address the overwhelming number of application requests, O’Day stated. 

The approach will boost emergency access for more individuals. Initial clinical trial sites in the US are up and running as of this week, and it is expected that sites in additional countries will be activated soon.

Roche Launches Phase III Clinical Trial of Potential Drug for Patients with Severe COVID-19 Pneumonia

In mid-March, Roche announced that it was initiating a randomized Phase III clinical trial to uncover the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard care in hospitalized adult patients with COVID-19 pneumonia. 

Roche worked with FDA and BARDA to launch the first global study of Actemra/RoActemra in this setting. Nearly 300 patients are expected to be enrolled sometime this month.

The clinical trial goal is to find clinical status, mortality, mechanical ventilation, and intensive care unit (ICU) variables.

“We are initiating a clinical trial to study Actemra/RoActemra for the treatment of people hospitalized with COVID-19 pneumonia, so that we can better establish the potential role for Actemra/RoActemra in fighting this disease,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development. 

“In these unprecedented times, today’s announcement is an important example of how industry and regulators can collaborate quickly to address the COVID-19 pandemic, and we will share the results as soon as possible.”

AI Drug Discovery Platform IDs Potential COVID-19 Treatments

Most recently, Gero leveraged its artificial intelligence drug discovery platform to identify 18 potential treatments for COVID-19, six of which were already approved.

Some of the identified drugs have previously been approved in countries for human and veterinary use, while others have been effective against SARS-CoV and SARS CoV-2 viruses.

Niclosamide and Nitazoxanide have recently been deemed as potential COVID-19 treatment drugs. 

Niclosamide is an oral anthelmintic drug used to treat parasitic infections, while Nitazoxanide is a broad-spectrum aniparasitic and broad-spectrum antiviral prescription drug used in medicine for the treatment of various helminthic, protozoal, and viral infections. 

Afatinib, a prescription medicine used to treat metastatic non-small cell lung cancer (NSCLC, was also identified by the drug discovery platform. 

“The fact that this time the potential treatments were found among the existing drugs marks a significant improvement over previous efforts to use AI to predict molecules active against COVID-19. The discovery makes it possible to start clinical trials in a matter of weeks,” Gero stated in the announcement. 

Trump Administration Pressures FDA to Approve Avigan, a Potential COVID-19 Drug

Most recently, the Trump Administration is encouraging regulators to allow Avigan, a Japanese flu medicine drug, to be administered as a potential COVID-19 treatment. 

Japan’s Prime Minister Shinzo Abe recently endorsed Avigan, a Japanese flu medicine drug. But FDA did not approve the drug in the US and previously rejected it over concerns about possible side effects.

Officials are urging the US government to accept a donation of Avigan from Japan, but this would require FDA to grant an emergency-use authorization (EUA). 

Fujifilm also recently announced the initiation of a phase III clinical trial to evaluate the safety and efficiency of Avigan.

In early March, Fujifilm began production of Avigan, but now through cooperation with various partners, the company will enhance the production to respond to the vital needs of the US and other countries.

Fujifilm intends to distribute the supply of Avigan to countries in consultation and coordination with the Japanese government to combat COVID-19 and contribute to tackling the spread of this global pandemic at the earliest possible stage.