Late last week, the first human clinical trial of an investigational vaccine began. Researchers at NIH’s National Institute of Allergy and Infectious Diseases (NIAID), in conjunction with individuals at Moderna, Inc., a biotech company out of Cambridge, Ma, developed this potential vaccine. Under the Phase I study, safety and efficacy of this vaccine will be tested in 45 healthy adults. If the vaccine passes this initial trial, larger clinical trials will be conducted to further confirm its efficacy and safety.
At that point, if all indicators point to a safe and effective vaccine, then large-scale production of the virus will occur. Production of vaccines in the quantity necessary to immunize all US citizens will take 12-18 months.
Refer to the NIH website for additional information about the development of this vaccine.
OFF-LABEL USE OF ANTIMALARIAL DRUG HYDROXYCHLOROQUINE
Chloroquine is an antimalarial drug. As the qualification suggests, the medication is intended to prevent or reduce the symptoms of malaria in children and adults. As it has been found to reduce rheumatoid arthritis symptoms and to aid those who suffer from lupus, scleroderma sarcoidosis and other immunological diseases, clinicians prescribe chloroquine to individuals suffering from this condition as well. Hydroxychloroquine is a drug also derived from quinine, which is also used to treat malaria and other immunological diseases. As effective as chloroquine, hydroxychloroquine produces fewer side effects.
“Off-label” use means that a drug is being utilized to treat a condition for which it was not approved by the FDA, and thus has little research to support safe use or efficacy beyond anecdotal evidence (e.g., word-of-mouth reports of how the drug positively impacted patients). Using chloroquine or hydroxychloroquine to treat is considered an off-label use because neither drug was approved by the FDA to treat viruses. However, anecdotal evidence from clinicians indicates that using chloroquine or hydroxychloroquine in conjunction with the antibiotic azithromycin has assisted in the recovery of those with COVID-19. Specifically, this drug combination appears to reduce symptoms and improve recovery time.
So, why would an antimalarial drug work here? Scientists postulate that chloroquine drugs could change the acidity at the surface of a cell. By altering the surface, COVID-19 would be prevented from infecting the cell.
To test the efficacy of hydroxychloroquine in patients with COVID-19, a group of physicians in France conducted a study with 20 subjects. Separated into three groups – those receiving hydroxychloroquine, those receiving hydroxychloroquine and the antibiotic azithromycin, and a control group who did not receive any medication) - over a two week period, the clinicians administering the study tracked each patient’s “viral load,” or how much of the virus remained in the nasal passageway of the subject. By Day 5 of the study, the viral load of patients that received hydroxychloroquine gradually dropped from Day 1. Those who received hydroxychloroquine in combination with the antibiotic azithromycin displayed a marked reduction in viral load by Day 5. As expected, the control group’s viral load remained high throughout the study.
Noting that this was a small group study, the clinicians involved in the research clarify in their paper that these results are preliminary. However, due to the nature of this pandemic, they published their results “given the urgent need for an effective drug” against COVID-19.
To understand more about the manner in which the study was conducted, a copy of the study can be found here:
Anecdotal evidence suggests that this combination of drugs is shortening the duration of symptoms. Investigations into the use of hydroxychloroquine to treat patients with mild-to moderate symptoms are underway by the FDA and the World Health Organization.
UPDATE: on March 28, 2020, the FDA approved off-label use of chloroquine and hydroxychloroquine to treat COVID-19. Because the request made the by the U.S. Department of Health and Human Services met the requirements to issue an Emergency Use Authorization (EUA), and in-vitro and anecdotal evidence suggest that these drug reduce the symptoms of COVID-19, Dr. Denise Hinton, Chief Scientists at the FDA, issued an EUA permitting immediate use of these drugs to treat COVID-19.
OTHER TREATMENTS BEING EXPLORED/UTILIZED
Remdesivir is an antiviral developed by Gilead Sciences. Testing in vitro (test tube) and in vivo (using animal subjects) provided evidence that Remdesivir effectively reduced viral activity of the following pathogens: MERS, SARS (two other coronaviruses), Ebola and Marburg virus. Because of the efficacy noted in vitro and in vivo, the National Institute for Allergy and Infectious Diseases (NIAID) is conducting a clinical trial for Remdesivir. Also, the manufacturer of Remdesivir, Gilead Sciences, just began two Phase III trials of this drug in Asia.
Regeneron Pharmaceuticals, in conjunction with Sanofi, began a clinical trial of sarilubam, an antibody to a specific receptor in the body known to play a key role in driving the inflammatory immune response. Aiming to learn if the drug can modify the inflammatory response triggered by COVID-19, the study is being conducted in New York medical centers.
Also being investigated is the use of antibody-rich blood products taken from people who have recovered from the virus.
More information about the above treatments can be found at the websites/articles linked here.