The World Health Organization is launching a multinational clinical trial in which four existing drugs will be used to treat patients with covid-19. The project currently includes 10 countries and will potentially involve thousands of patients currently battling the coronavirus-caused disease.
Vaccines to inoculate humans against covid-19 may not arrive for a year or more, but treatments to save lives and shorten the length of illness are another story. Like vaccines, antiviral medications can take years to develop, but the medical community already has an assortment of promising or licensed drugs that might prove their worth in the battle against SARS-CoV-2, the virus that causes covid-19.
To find out which of these drugs might work best, the World Health Organization (WHO) has launched a multinational clinical study called the Solidarity Trial. Countries currently signed up include Canada, France, Argentina, Bahrain, Thailand, Iran, Norway, South Africa, Spain and Switzerland, according to a WHO statement. Science magazine reports that the trial could involve thousands of patients and potentially dozens of countries as the outbreak continues to spread.
The need for effective antiviral treatments is dire. As of March 23, over 354,000 people have been infected by SARS-CoV-2 and 15,436 have died, according to statistics gathered by Johns Hopkins University.
“Multiple small trials with different methodologies may not give us the clear, strong evidence we need about which treatments help to save lives,” said Tedros Adhanom Ghebreyesus, the general-director of the WHO, at a press conference held last week, reports Global News. “WHO and its partners are therefore organizing a study in many countries in which some of these untested treatments are compared with each other.”
For the Solidarity Trial, physicians will target four different drugs and/or combinations: (1) remdesivir, (2) the combination of lopinavir and ritonavir, (3) lopinavir and ritonavir combined with interferon beta, (4) and chloroquine and hydroxychloroquine, reports STAT. These drugs and combinations will be used in the field in patients currently diagnosed with covid-19. The outcomes in those patients will then be compared to the outcomes of patients who received the standard model of care for the disease in each locale.
These drugs might sound familiar, as they’re already used to treat other communicable diseases. Remdesivir inhibits an enzyme used by viruses for self-replication, and it’s used to treat diseases caused by the Ebola and Marburg viruses. Recently, remdesivir emerged as a candidate drug to treat coronaviruses, including SARS, MERS, and SARS-CoV-2. The combination of lopinavir and ritonavir is used to treat HIV, and the addition of interferon beta to this mix adds a potent immune system messenger to the compound, which acts to disable viruses. Chloroquine and hydroxychloroquine used both to prevent and treat malaria, which is transmitted by mosquitoes.
The Solidarity Trial seek to determine if any of these drugs can slow SARS-CoV-2 within the human body and possibly even eliminate it. Ultimately, physicians need something to reduce death rates and the number of patients being admitted to intensive care units (ICUs). These drugs could possibly be used proactively to protect frontline healthcare workers from covid-19, reports Science magazine.
By design, the testing protocols for the Solidarity Trial are exceptionally simple; this trial will have to be done under tremendous pressures, as frontline physicians work to treat covid-19 patients in the field and as hospitals become increasingly inundated with new cases.
As Science magazine reports, consenting eligible patients will be added to a centralized WHO website. Physicians will input data about the patient, including pre-existing health conditions. Physicians will also list the drugs available to them at their hospital or healthcare facility. Based on this, the system will randomly assign the patient to one of the four different drug therapy or the local standard of care model (which will serve as the control). Physicians will continue to enter data into the system over the course of the treatment.
Bioethicist Arthur Caplan from New York University Langone Medical Center told Science magazine that he likes this design, saying, “No one wants to tax the frontline caregiver who’s overwhelmed and taking risks anyway.”
It could take a few weeks to a few months to analyze these results, but that’s still a vast improvement over designing new drugs from scratch.
Importantly, lopinavir-ritonavir “did not show promise for treatment of hospitalized COVID-19 patients with pneumonia in a recent clinical trial in China,” according to the U.S. Centers for Disease Control and Prevention. That said, the “fact the WHO is sponsoring the trial suggests that efforts in China to test these drugs may not have come up with enough data to indicate whether any were of use to prevent patients from developing severe disease or save those with severe disease from death,” according to STAT.
The United States is currently not part of the Solidarity Trial. Several European countries recently announced a clinical trial called Discovery, which will look at the same drugs and drug combinations as the Solidarity Trial.
Indeed, the war against covid-19 has only just begun. With great steadfastness and patience, we’ll hopefully find new ways to combat this menace and turn the tide.