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What are dual treatments and are there any available for COVID-19 right now?

This article was published on
July 3, 2020

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"Combination treatments" are the use of two or more drugs to treat a single disease. Currently, there are no combination treatments (also known as dual treatments) that are officially approved for use to treat COVID-19. However, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, announced on June 23, 2020 while testifying before a House committee on the U.S. response to the COVID-19 pandemic that Remdesivir is being used in combination with anti-inflammatory drug baricitinib. An NIH clinical trial has been underway since May to test the efficacy of the combined treatment, with results not yet released. Only three standalone drugs have officially received emergency use authorization (EUA) from the Federal Drug Administration (FDA) in the US; these include the anti-viral remdesivir (which the WHO has issued a warning for but which still has an EUA in the US), anti-malaria drugs chloroquine and hydroxychloroquine (which the FDA later issued a warning for), and a drug used to sedate patients that are on a ventilator. (These EUAs do not constitute a formal approval of the drug, but rather a possibility given to American doctors to use chloroquine and hydroxychloroquine in the treatment of COVID-19 if the doctor has no other options and after discussing with the patients the risks involved.) In terms of approval of combination treatments, on November 19, 2020, the FDA issued an EUA for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). One example of a combination therapy being tested is the dual use of drugs lopinavir and ritonavir, which are in use to treat (not cure) HIV. The combination of these two drugs is known under the brand name Kaletra. Studies are still relatively inconclusive, but most have shown Kaletra to be ineffective for improving COVID-19 outcomes. One study, however, found that when taken with two other drugs — ribavirin and interferon beta-1b — the virus took less time to clear from the patient's body. There are a number of limitations from this trial that warrant further testing. Other studies testing combination therapy have focused on pairs with remdesivir. One study, which led to the combination treatment approved through an EUA by the FDA mentioned above, tested the impacts of remdesivir and anti-inflammatory drug known as baricitinib on time to recovery in hospitalized patients and found a significant reduction. Another tested the combination of remdesivir with the drug leronlimab, an antiviral that has also has shown to have some anti-inflammatory benefits. Studies are also exploring more holistic and less pharmacological approaches as complementary COVID-19 treatment — that is, a potential additional treatment used in combination with other COVID-19 treatments. For instance, some researchers are exploring Traditional Chinese Medicine as a complementary therapy to combat COVID‐19 in conjunction with other therapies being used such as antiviral medications and antibiotics. Virgin coconut oil (VCO) is also being studied in the Philippines and other countries as a potential supplementary treatment for COVID-19 such as antiviral medications and antibiotics. These studies assessing combination treatments will get us closer to understanding if certain combination therapies might be effective for treating COVID-19.

"Combination treatments" are the use of two or more drugs to treat a single disease. Currently, there are no combination treatments (also known as dual treatments) that are officially approved for use to treat COVID-19. However, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, announced on June 23, 2020 while testifying before a House committee on the U.S. response to the COVID-19 pandemic that Remdesivir is being used in combination with anti-inflammatory drug baricitinib. An NIH clinical trial has been underway since May to test the efficacy of the combined treatment, with results not yet released. Only three standalone drugs have officially received emergency use authorization (EUA) from the Federal Drug Administration (FDA) in the US; these include the anti-viral remdesivir (which the WHO has issued a warning for but which still has an EUA in the US), anti-malaria drugs chloroquine and hydroxychloroquine (which the FDA later issued a warning for), and a drug used to sedate patients that are on a ventilator. (These EUAs do not constitute a formal approval of the drug, but rather a possibility given to American doctors to use chloroquine and hydroxychloroquine in the treatment of COVID-19 if the doctor has no other options and after discussing with the patients the risks involved.) In terms of approval of combination treatments, on November 19, 2020, the FDA issued an EUA for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). One example of a combination therapy being tested is the dual use of drugs lopinavir and ritonavir, which are in use to treat (not cure) HIV. The combination of these two drugs is known under the brand name Kaletra. Studies are still relatively inconclusive, but most have shown Kaletra to be ineffective for improving COVID-19 outcomes. One study, however, found that when taken with two other drugs — ribavirin and interferon beta-1b — the virus took less time to clear from the patient's body. There are a number of limitations from this trial that warrant further testing. Other studies testing combination therapy have focused on pairs with remdesivir. One study, which led to the combination treatment approved through an EUA by the FDA mentioned above, tested the impacts of remdesivir and anti-inflammatory drug known as baricitinib on time to recovery in hospitalized patients and found a significant reduction. Another tested the combination of remdesivir with the drug leronlimab, an antiviral that has also has shown to have some anti-inflammatory benefits. Studies are also exploring more holistic and less pharmacological approaches as complementary COVID-19 treatment — that is, a potential additional treatment used in combination with other COVID-19 treatments. For instance, some researchers are exploring Traditional Chinese Medicine as a complementary therapy to combat COVID‐19 in conjunction with other therapies being used such as antiviral medications and antibiotics. Virgin coconut oil (VCO) is also being studied in the Philippines and other countries as a potential supplementary treatment for COVID-19 such as antiviral medications and antibiotics. These studies assessing combination treatments will get us closer to understanding if certain combination therapies might be effective for treating COVID-19.

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"Combination treatments" are the use of two or more drugs to treat a single disease. Currently, there are no combination treatments (also known as dual treatments) that are officially approved for use to treat COVID-19. However, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, announced on June 23, 2020 while testifying before a House committee on the U.S. response to the COVID-19 pandemic that Remdesivir is being used in combination with anti-inflammatory drug baricitinib. An NIH clinical trial has been underway since May to test the efficacy of the combined treatment, with results not yet released.

Only three standalone drugs have officially received emergency use authorization (EUA) from the Federal Drug Administration (FDA) in the US; these include the anti-viral remdesivir (which the WHO has issued a warning for but which still has an EUA in the US), anti-malaria drugs chloroquine and hydroxychloroquine (which the FDA later issued a warning for), and a drug used to sedate patients that are on a ventilator. (These EUAs do not constitute a formal approval of the drug, but rather a possibility given to American doctors to use chloroquine and hydroxychloroquine in the treatment of COVID-19 if the doctor has no other options and after discussing with the patients the risks involved.)

In terms of approval of combination treatments, on November 19, 2020, the FDA issued an EUA for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

One example of a combination therapy being tested is the dual use of drugs lopinavir and ritonavir, which are in use to treat (not cure) HIV. The combination of these two drugs is known under the brand name Kaletra. Studies are still relatively inconclusive, but most have shown Kaletra to be ineffective for improving COVID-19 outcomes. One study, however, found that when taken with two other drugs — ribavirin and interferon beta-1b — the virus took less time to clear from the patient's body. There are a number of limitations from this trial that warrant further testing.

Other studies testing combination therapy have focused on pairs with remdesivir. One study, which led to the combination treatment approved through an EUA by the FDA mentioned above, tested the impacts of remdesivir and anti-inflammatory drug known as baricitinib on time to recovery in hospitalized patients and found a significant reduction. Another tested the combination of remdesivir with the drug leronlimab, an antiviral that has also has shown to have some anti-inflammatory benefits.

Studies are also exploring more holistic and less pharmacological approaches as complementary COVID-19 treatment — that is, a potential additional treatment used in combination with other COVID-19 treatments. For instance, some researchers are exploring Traditional Chinese Medicine as a complementary therapy to combat COVID‐19 in conjunction with other therapies being used such as antiviral medications and antibiotics. Virgin coconut oil (VCO) is also being studied in the Philippines and other countries as a potential supplementary treatment for COVID-19 such as antiviral medications and antibiotics.

These studies assessing combination treatments will get us closer to understanding if certain combination therapies might be effective for treating COVID-19.

Context and background

Given the current absence of a COVID-19 treatment, and the lack of a widely approved or distributed vaccine, researchers are urgently looking for treatments for the disease. To this end, there is a wide range of both existing drugs (i.e. approved and regulated for different health conditions) and potential new ones being tested globally. These tests are being conducted in laboratories and animal clinical studies, and once proven effective they are moved onto human clinical trials. In addition to studies on singular drugs, researchers are testing what are known as combination therapies, in which two or more drugs are taken to treat a single disease. The rationale for combination therapy is that different drugs work through different mechanisms, and grouping more than one together can increase the treatment's efficacy, reduce treatment duration, and reduce the likelihood of drug resistance.

Resources

  1. Combination Therapy (Science Direct)
  2. Combination Therapy for COVID-19, Rajesh T. Gandhi, MD reviewing Hung IFN et al. Lancet 2020 May 8 (NEJM)
  3. Here’s Exactly Where We Are with Vaccines and Treatments for COVID-19 (Healthline)

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