COVID-19: DRUGS AND TREATMENTS
While there are no available treatments for any human coronavirus (it may be a common coronavirus spreading cold or the SARS-CoV-2 virus), some existing antiviral medications, such as those used for Ebola and malaria, are used to treat Covid-19 and they show some efficacy against the novel coronavirus (nCoV). These work by disabling the viruses by interfering with their attempts to replicate in host cells. Another class of drugs used are the ‘protease inhibitors that alert the immune system to viruses. They may be useful against coronaviruses.
In the months following the outbreak of the novel coronavirus, the World Health Organization (WHO) planned a global research and innovation meeting on the coronavirus on February 11-12 in Geneva. Scientists from all over the world were to attend and clinical trials of promising candidates were being planned. This was even as a randomised controlled clinical trial was underway in China to test the anti-HIV drugs’ efficacy, according to a study published on January 24 in The Lancet.
With the spread of Covid-19 from being a regional crisis to a global threat, countries have been in a hurry to use the existing drugs for thwarting the pandemic. A number of drugs were investigated for their value in treating COVID-19. To produce drugs to work against the disease, drugmakers have either taken a cue from older antivirals or tried to tap tried-and-true technologies. The attempt is also to examine futuristic approaches to human medicine.
The treatment protocol established in China and followed by physicians in Thailand showed that a combination of lopinavir and ritonavir, along with flu medication oseltamivir, maybe working on patients. According to reports, a flu drug from Japan may be effective in treating patients, while other institutions are experimenting with the blood pressure drug, losartan to see if it could prevent the virus from infecting patients in the first place.
The COVID-19 drugs being tried and tested fall into 2 general categories:
- antivirals aimed at limiting the spread of the coronavirus inside the bodies of infected people, and
- immune system medications that limit the damage the body does to itself while fighting off the coronavirus.
Some attempts to produce drugs and treatments to treat coronavirus infection have been specifically in news. These are discussed below.
EIDD-2801: Oral Medicine to Hinder the Novel Coronavirus
In April 2020, scientists announced that an oral medicine, a drug called EIDD-2801, was able to hinder the coronavirus behind COVID-19 as it attempted to replicate itself in human lung cells in test tubes. It also hampered closely-related coronaviruses from reproducing in mice for several days and improved the functioning of their lung, according to an article in the journal Science Translational Medicine.
EIDD-2801 interferes with a key mechanism that allows the SARS-CoV-2 virus to reproduce in high numbers and cause infections. Human trials, however, are yet to be done. If effective in people, the drug would be significant, as oral medication is always easier to administer and can be given to a larger number of people than, say, intravenous injections.
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The study was done by a team at Emory University, the University of North Carolina at Chapel Hill and Vanderbilt University Medical Center in Nashville, USA. Ridgeback Biotherapeutics, the company that has licensed the drug, said it would begin 10 patient trials of the antiviral pill.
About EIDD-2801The findings indicate that EIDD-2801 is possibly even more successful in disrupting coronavirus replication than the experimental medicine remdesivir by Gilead Sciences. Remdesivir was effective in shutting down the replication of the coronaviruses that caused the original SARS and MERS epidemics. It has received attention because it entered clinical trials against SARS-CoV-2 in March 2020.
EIDD-2801 inhibits the coronavirus’ self-copying operations in a manner that is different from remdesivir. While remdesivir brings that replication process to a full stop, EIDD-2801 introduces mutations—mistakes—into the virus’s RNA as it makes copies so that the viral RNA becomes so damaged that it cannot infect cells.
Many Use An important feature of EIDD-2801 is that it is able to work against a host of RNA viruses. Thus, it could serve as a multipurpose antiviral, just as some antibiotics can work against various bacteria. In preclinical studies, researchers have found that EIDD-2801 was effective against many strains of influenza, viruses for respiratory syncytial virus and viruses for chikungunya, Venezuelan equine encephalitis and Eastern equine encephalitis. These are microbes that affect people in different parts of the world.
The compound may be initially beneficial as a prophylaxis [that] health care workers can take to prevent an infection. Another potential use of EIDD-2801 might be to protect uninfected nursing home residents and workers if an outbreak occurs inside a facility.
An aim is to use the drug as an oral pill that can be taken twice a day by patients at home early in the course of the Covid-19 disease to prevent it from progressing to hospitalisation, mechanical ventilation or death.
Development EIDD-2801 was first produced by Emory Institute for Drug Development. In 2018, George Painter, a professor of chemistry and executive director of the institute, and the labs he leads identified EIDD-2801’s activity during a search for a universal influenza medicine. In October 2019, the Emory program got $15.9 million from the National Institute of Allergy and Infectious Diseases to perform human tests of the drug against the flu virus that was likely to be circulating later in the year. When SARS-CoV-2 emerged, Painter’s group immediately shifted focus.
Anti-malaria-Antibiotic Drug Combo Shows Promise
A specific combination of existing drugs including the anti-malaria drug hydroxychloroquine and the antibiotic azithromycin may be successful against the novel coronavirus, according to a study donein France, the results of which were published in the International Journal of Antimicrobial Agents.
A group of 30 COVID-19 patients, split into 3 groups (10 patients received just the anti-malaria drug, another ten received both hydroxychloroquine in combination with the antibiotic, and the remaining 10 formed the control group and did not receive any treatment) were administered the combo drug on a trial basis.
Though the anti-malaria medication proved to significantly reduce the duration of the infection in the patients who received it, the combination of both drugs produced unexpected results. By the fifth day of treatment, all of the patients who had been administered the drug combo tested negative for the active virus.
The drawback of the test was that it was very small in scale. A much larger test would give a more accurate idea of how effective these treatment options are.
Chinese Institutes File Patent For US Drug
In January 2020, researchers from top Chinese institutes including the Wuhan Institute of Virology (WIV) and the Chinese Academy of Military Sciences applied to patent a US-made drug they found to be effective in pre-clinical tests in treating the novel coronavirus (nCoV).
According to the WIV, the drugs, remdesivir and the generic chloroquine, could inhibit or check the coronavirus. WIV is the only institute in China to have a bio-safety level 4 laboratory, a lab which is equipped to deal with the deadliest pathogens in the world including Ebola and the coronavirus family.
China says it is capable of manufacturing chloroquine and now wants to start using remdesivir to treat Coronavirus patients.
The manufacturer of remdevisir, Gilead, was shipping enough doses to China to treat 500 patients initially. The drugwas expected to go into clinical trials in China immediately in patients with moderate and severe symptoms of the virus.With the support of the ministry of science and technology, the national health commission and the state food and drug administration, the antiviral drug remdesivir had completed the registration and approval of clinical trials. The first group of severe pneumonia patients infected with the new coronavirus were to be given the drug on February 6.
India: ICMR For Restricted Use Of Two Anti-HIV Drugs
In February 2020, the Indian Council of Medical Research (ICMR) stated that an expert committee had been constituted by it for deliberating on the new treatment protocol for dealing with the novel coronavirus (nCoV). The standard treatment protocol for dealing with coronavirus infections would comprise a cocktail of antiretrovirals used to treat HIV/AIDS, similar to protocols being followed in China.
ICMR obtained permission for “restricted use in public health emergency” of 2 second-line HIV medications for use against the novel coronavirus (nCoV). They were to be used only in “vulnerable” cases, as they had side-effects. Senior citizens, children, those with existing conditions such as diabetes and heart disease are among those considered vulnerable. They had not yet been administered as of then.
An in-principle approval was taken from the DCGI for these drugs to be used for coronavirus in case it turned virulent after 3 persons were diagnosed with the infection in Kerala (they were studying in Wuhan).
CiplaNSE and Aurobindo are the main suppliers of these antiretrovirals in India. Indian generic companies, which are among the largest manufacturers of antiretrovirals, however, said that they were prepared to supply to the government if the need arose.
Some 70 per cent of HIV-positive people in India are on first-line drugs. The combination of Lopinavir and Ritonavir, the 2 second-line HIV medications, has now been approved for emergency medical use to treat COVID-19 only if the nCoV situation in India turned into a public health emergency. Guidelines have been framed for their use.
A total 534 suspected cases had been tested by early February in India, and 3 were confirmed with the virus. Of the tested samples, 160 were from quarantine centres set up for individuals evacuated from Wuhan. In addition to the National Institute of Virology, Pune, 11 virus and research diagnostic laboratories (VRDLs) are performing tests for the coronavirus.
Where treatment is concerned, 2 of 3nCoV patients in the country have shown signs of lower viral load with traditional treatment, according to sources in the Health Ministry. Although people continue to test positive for the virus, the lowering of the viral load seems to suggest that in healthy young individuals, the virus may not need aggressive medication. So while it is extremely infectious, nCoV 2019 is not exactly a deadly virus; it has a fatality rate of only 3 per cent, according to officials.
Hong Kong-based expert virologist Malik Peirishad earlier stated that coronavirus is less severe, although it is much more difficult to control. He said that in the absence of specific anti-viral medication or vaccine, “good hospital management can dramatically improve clinical outcomes and survival”. Malik Peiris, who played a key role in identifying the SARS virus in 2003, has said that anti-viral medication used during SARS and MERS-coronavirus outbreaks had included anti-HIV medication. He said that the drug worked in test tubes, however, it was not clear whether it was actually beneficial in real patients. So randomised clinical trials were required.
Specific Drugs/Treatments in News
* Intravenous Drug, Remdesivir and Anti-malarials
The efficacy of the 2 drugs, remdesivir and chloroquine, in the control of 2019-nCoV (novel Coronavirus) infection in vitro was first reported by researchers from the Wuhan Institute of Virology and the Chinese Academy of Military Sciences in a paper published in the medical journal Cell Research.
Remdesivir has been recently recognised as a promising antiviral drug against a wide array of RNA viruses (including SARS/MERS-CoV5) infection in cultured cells, mice and nonhuman primate (NHP) models. It has been under clinical development for the treatment of Ebola virus infection. (The drug, interestingly, failed in a study conducted on Ebola virus.) Remdesivir drug by Gilead Sciences for treatment, at the stage of Phase 3, has been in five clinical trials around the world. Administered intravenously, in China, about 1,000 Covid-19 patients were recruited to determine whether multiple doses of remdesivir could reverse the infection, by reducing fever and helping patients recover within two weeks.
The drug attacks the genetic code of the COVID-19 coronavirus, hampering its ability to replicate, according to a review of potential coronavirus therapies published in the journal Pharmacotherapy.Early studies in small groups have shown benefit in patients, but doctors are still waiting on results from larger clinical trials to verify those findings.
Chloroquine is a cheap and a safe drug that has been used for more than 70 years and, therefore, it is potentially clinically applicable against the 2019-nCoV, according to the paper. However, anti-malarials, Chloroquine and hydroxychloroquine, touted as one of the great hopes for COVID-19 treatment, have failed in several major studies. Clinical trials are ongoing for the two drugs, but researchers aren’t holding out much hope. They have also resulted in a controversy as a US study focusing on its use in US veterans hospitals found that 28 per cent of patients treated with hydroxychloroquine died versus 11 per centof those who didn’t get the drug. Even as it’s very unclear whether it has been beneficial, there have been more reports of toxicity from its use.
Many of the drugs proposed to treat COVID-19 are already approved for other conditions and can be put into immediate off-label use. But that’s not the case with the IV drug called remdesivir, originally developed to treat Ebola and MERS (Middle East respiratory syndrome). Remdesivir is not an approved drug, so the only way to get it is if one conducts a clinical trial or through a compassionate use programme.
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*Some Antivirals
A combination of antiviral drugs is being tested by the Chinese drugmaker Ascletis Pharma to treat coronavirus infection. The treatment is at stage 1. The antivirals include one approved for HIV and another approved for hepatitis C.In a successful attempt, the company enrolled 11 patients with coronavirus-caused pneumonia and administered a mix of the drugs, danoprevir and ritonavir. All the patients were finally discharged, according to Ascletis.
Lopinavir, ritonavir and nelfinavir are drugs which were all developed as ways to interfere with the viral replication of HIV; in the case of MERS and SARS (the other human coronaviruses before COVID-19), there was some interest in lopinavir/ritonavir.
Early randomised trials out of China have not shown any particular benefit, and some institutions may have stopped using them but the World Health Organization and others are still including one or more of these drugs in ongoing COVID-19 clinical trials.
Ribavirin, the broad-spectrum antiviral drug, earlier used to treat hepatitis, is being tried as a COVID-19 therapy. Though the drug inhibits viral replication by interfering with genetic synthesis, it comes with many side effects. Ribavirin’s inhaled formulation, for example, can be toxic to fetuses and is not indicated either for pregnant women or their male partners. The drug can cause anaemia and low blood levels of calcium and magnesium and has the potential to interact dangerously with immune suppression therapies.
Interferon-alpha is one of the older antiviral agents, examined as a means of treating hepatitis and some cancers. It is based on a protein the body makes to direct immune response. But it’s given as a medication to administer a dosage beyond what the body makes. However, there has been little laboratory evidence that interferon-alpha is effective in treating other coronaviruses, either SARS or MERS. Interferon-alpha generally isn’t used to treat chronic infections like hepatitis because it can cause depression and flu-like symptoms. However, it could perhaps be applied to short-lived infections like COVID-19. Studies are being conducted to assess whether interferon-alpha used in combination with ribavirin could help treat COVID-19 patients.
*Nitazoxanide
The drug Nitazoxanideahs have been approved by the U.S. Food and Drug Administration to treat diarrhoea caused by Giardia parasites, and it has been found to also act against cryptosporidium parasites and some bacteria. The medication could potentially inhibit the expression of proteins found on the surface of the COVID-19 coronavirus that allow the virus to invade human cells. Studies conducted in the laboratory with animals have shown that the drug can reduce infections of MERS and other coronaviruses even as this was contradicted by a study published late-2019 in the journal Clinical Infectious Diseases that found that the drug did not improve the condition of coronavirus patients.
*Arbidol, Favipiravir and Baloxavir
Arbidol, Favipiravir and Baloxavir, approved to treat flu in other nations, are being studied as emerging potential therapies for COVID-19.
Favipiravir is being tested in a clinical trial in the United States while other countries are testing the other drugs for their potential in fighting the new coronavirus.
The drugs all work by blocking either the virus’ ability to replicate or to enter human cells.
*Immune-system Modulating Drugs: Tocilizumab and Baricitinib
These immune system-modulating drugs were originally developed to treat rheumatoid arthritis and other inflammatory diseases. Researchers say that they could help COVID-19 patients because the coronavirus appears to trigger an overactive immune response in some people, doing a lot of damage to organs and increasing the risk of death. The drugs block one of the alarm bells of the immune system and try to keep the immune response under control.
Clinical trials for tocilizumab and baricitinib are either underway or in preparation, experts said.
* Kevzara, Anti-Inflammatory Drug
The known anti-inflammatory drug, Kevzara, may help with the symptoms of Covid-19. Sanofi and Regeneron are companies that have started a clinical trial to test its efficacy.
Many of the drugs mentioned above could work for treating COVID-19 patients though often the actual effects are not encouraging. One needs to know that the history of medicine is filled with instances of things that looked good in test tubes or in animals but didn’t work well in humans.
*Antibody Treatments
Antibody treatments are being developed for coronavirus infections.
An attempt by Eli Lilly in partnership with AbCellera company, at the preclinical stage, uses a blood sample from a coronavirus survivor. AbCellera identified more than 500 antibodies that might protect against the virus. The next step is to identify those antibodies that are most potent. The goal is to have a treatment ready for human trials by mid-2020.
Isolating antibodies from those who have survived SARS, a viral relative of the novel coronavirus, is being considered as a way of treating the infection. San Francisco-based Vir Biotechnology, a company focused on infectious disease, has teamed up with Chinese pharma contractor WuXi Biologics, to produce a treatment that was at the pre-clinical stage in March 2020. It is also working with Alnylam Pharmaceuticals to work on treatments that might halt viral replication by interfering with RNA signalling.
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Takeda of Japan is working on a treatment that involves drawing blood from coronavirus survivors, harvesting the plasma, and then isolating the protective antibodies that kept those patients alive. This idea has been there in research: blood transfusions have been used to combat viral outbreaks since at least the Spanish Flu pandemic of 1918. But the pharma giant Takeda’s attempt, though at the preclinical stage, could be faster in development than other therapeutic approaches. It says that the therapy in line could be available to patients in a year or a year-and-a-half.
Regeneron Pharmaceuticals has been working on crafting human antibodies out of genetically engineered mice. The $50 billion business company is now tapping that technology to treat Covid-19. It said that it has immunised its proprietary antibody-generating mice with a harmless analog of the novel coronavirus. The two most potent antibodies would be selected. The attempt is in the preclinical stage. During the Ebola outbreak of 2015, the company came up with a combination of antibodies to treat Ebola patients that roughly doubled survival rates for treated patients.
Homeopathy And Ayurveda To Prevent Coronavirus?
In January 2020, the AYUSH ministry issued a statement recommending that the homoeopathic medicine Arsenicum album 30 could be taken as a “prophylactic (preventive) medicine against possible coronavirus infections”. It said, “The Group of Experts inter-alia has recommended that homoeopathy medicine Arsenicum album 30 could be taken as prophylactic medicine against possible coronavirus infections… It has recommended one dose daily in empty stomach for three days. The dose should be repeated after one month by following the same schedule in case coronavirus infections prevail in the community.”
The ministry first issued an advisory asking people to use homoeopathy to prevent coronavirus infection. After the announcement, it began facing huge flak for issuing the ‘unscientific’ advisory. So the ministry came up with a rejoinder saying that the advisory was a “preventive measure and not claiming to be treatment advice for the coronavirus infection”.
The advisory was issued following the 64th meeting of the scientific advisory board of the Central Council for Research in Homoeopathy (CCRH) under the ministry a day before to discuss ways and means for the prevention of the nCoV infection through homoeopathy.
The AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa and Homoeopathy) ministry also issued a list of Ayurvedic concoctions for prevention of the virus.
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The prescription for Ayurvedic concoction states: “Drink ShadangPaniya (Musta, Parpat, Usheer, Chandan, Udeechya and Nagar) processed water (10 gm powder boiled in 1-litre water, until it reduces to half). Store it in a bottle and drink it when thirsty. Agastya Harityaki 5 gm, twice a day with warm water, SamshamaniVati 500 mg twice a day, Trikatu (Pippali, Marich and Shunthi) powder 5 gm and Tulasi 3-5 leaves (boiled in 1-litre water, until it reduces to ½ litre and keeps it in a bottle) keep taking it in sips as and when required. PratimarsaNasya: Instill two drops of Anutaila/Sesame oil in each nostril daily in the morning.”
The health ministry did not comment on the advisory. It said that as the advisory had been issued by the Ayush ministry, any clarification should be sought from them. Health experts also declined to comment on the advisory on the ground that their information on Ayurveda, homeopathy and Unani was limited.
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