Treatments for COVID-19

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Harvard Health Publishing – Harvard Medical School

What helps, what doesn’t, and what’s in the pipeline.

Most people who become ill with COVID-19 will be able to recover at home. Some of the same things you do to feel better if you have the flu — getting enough rest, staying well hydrated, and taking medications to relieve fever and aches and pains — also help with COVID-19.

Beyond that, the FDA has also authorized treatments that may be used for people who have been hospitalized with COVID-19 and other medications to curb the progression of COVID-19 in people who are not hospitalized but who are at risk for developing severe illness. Scientists continue working hard to develop other effective treatments.

I have tested positive for COVID-19 but am experiencing only mild symptoms. What will help me to recover at home?

Let your doctor know that you have COVID-19. Some people who are at increased risk for severe COVID-19 illness may be candidates for oral antiviral treatment or intravenous monoclonal antibody therapy, both of which can reduce the risk of hospitalization and death.

If you’ve been told to recover at home, these measures can help reduce symptoms:

  • While you don’t need to stay in bed, you should get plenty of rest.
  • Stay well hydrated.
  • To reduce fever and ease aches and pains, take acetaminophen or ibuprofen. Be sure to follow directions. If you are taking any combination cold or flu medicine, keep track of all the ingredients and the doses. For acetaminophen, the total daily dose from all products should not exceed 3,000 milligrams.

Is it safe to take ibuprofen to treat symptoms of COVID-19?

Early in the pandemic, there were some concerns that NSAIDs such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve) might not be safe for people with COVID-19. However, the CDC now recommends taking medications, such as ibuprofen or acetaminophen, to relieve fever if you have COVID-19. And the WHO has stated that there is no evidence that ibuprofen has any negative effects for people with COVID-19.

What therapies can help people who are at increased risk of severe COVID-19 to avoid hospitalization?

There are currently two FDA-authorized monoclonal antibody treatments that may be used to treat non-hospitalized adults and children over age 12 with mild to moderate symptoms who have recently tested positive for COVID-19, and who are at risk for developing severe COVID-19 or being hospitalized for it. These therapies must be given intravenously (by IV) soon after developing symptoms.

The monoclonal antibody treatments that have FDA authorization are: sotrovimab, made by GlaxoSmithKline, and bebtelovimab, made by Eli Lilly. Both appear to be effective against the Omicron variant; in laboratory tests, bebtelovimab was also effective against the BA.2 omicron subvariant.

In addition, the FDA has authorized the oral antiviral medications Paxlovid and molnupiravir, which have been shown to lower the risk of hospitalization and death in people who are at increased risk of severe COVID-19 illness.

Is there an antiviral pill that can reduce my risk of being hospitalized if I get COVID-19?

The FDA has authorized two antiviral pills for the treatment of COVID-19.

Paxlovid

On December 22, 2021, the FDA authorized an oral antiviral pill, called Paxlovid, for the treatment of mild-to-moderate COVID-19 in people ages 12 and older who are at increased risk for severe illness. The treatment is available by prescription only, after a positive COVID-19 test and within five days of symptom onset. The FDA’s authorization was based on study results released by Pfizer, the drug’s manufacturer, showing that Paxlovid significantly reduces the risk of COVID-related hospitalization and death compared to a placebo.

The phase 2/3 study, known as EPIC-HR, was randomized, double-blind, and placebo controlled. Study participants had symptomatic, confirmed, early COVID-19, were at increased risk for severe illness due to age or an underlying medical condition, and were not hospitalized. The 2,246 study participants took either a placebo or Paxlovid treatment (three tablets twice a day for five days), beginning treatment within five days of symptom onset.

By 28 days after treatment, those who had taken Paxlovid within five days of the start of symptoms had an 88% reduced risk of COVID-related hospitalization or death compared to placebo. Side effects of Paxlovid and placebo were comparable, and generally mild. They included impaired sense of taste, diarrhea, high blood pressure, and muscle aches.

Paxlovid is a protease inhibitor antiviral therapy made up of a medicine called nirmatrelvir and the HIV drug ritonavir. Nirmatrelvir was developed by Pfizer; it interferes with the ability of the coronavirus to replicate. Ritonavir slows the breakdown of nirmatrelvir, which translates to higher blood levels of nirmatrelvir and greater antiviral action for longer periods of time.

Laboratory study results, also announced in a Pfizer press release, suggest that Paxlovid is effective against the Omicron variant.

Paxlovid is not authorized to prevent infection, to prevent illness after exposure (prior to diagnosis), or to treat someone hospitalized with severe COVID-19. Antiviral medication is also not a substitute for getting vaccinated. The COVID vaccine, including boosters, remains more important than ever. We need layers of defense against this viral threat.

Molnupiravir

On December 23, 2021, the FDA authorized molnupiravir, an oral antiviral treatment manufactured by Merck, for the treatment of mild to moderate COVID-19 in people ages 18 years and older who are at increased risk for severe illness. The treatment is available by prescription only, after a positive COVID-19 test and within five days of symptom onset. However, the FDA indicated that use of molnupiravir should be limited to situations in which other COVID-19 treatments “are not accessible or clinically appropriate.”

In November, Merck released study results showing that compared to placebo, molnupiravir reduced the risk of hospitalization and death by 30% in people with mild or moderate COVID-19 who were at high risk for severe COVID.

The study results were based on data from 1,433 study participants from the US and around the world. To be eligible for the randomized, placebo-controlled, double-blind study, the participants had to have been diagnosed with mild to moderate COVID-19, have started experiencing symptoms no more than five days prior to their enrollment in the study, and have at least one risk factor that put them at increased risk for a poor outcome from COVID-19. None of the participants were hospitalized at the time they entered the study. About half of the study participants took the antiviral drug molnupiravir: four capsules, twice a day, for five days, by mouth. The remaining study participants took a placebo.

Patients taking molnupiravir were 30% less likely to be hospitalized or die from COVID-19 than those taking a placebo. Over the 29-day study period, 48 out of 709 (6.8%) of participants who took molnupiravir were hospitalized, and one person in this group died. In the placebo group, 68 out of 699 (9.7%) of participants were hospitalized, including nine participants in this group who died. The antiviral drug was effective against several COVID variants, including the Delta variant. Scientists are looking into the effectiveness of molnupiravir against the Omicron variant.

Side effects of molnupiravir include diarrhea, nausea, and dizziness. The drug is not recommended for use during pregnancy.

Molnupiravir was developed by Merck and Ridgeback Biotherapeutics. It works by interfering with the COVID virus’s ability to replicate.

Is the antidepressant drug fluvoxamine effective for treating COVID-19?

A large study published in Lancet Global Health in October 2021 found that the antidepressant fluvoxamine (Luvox), which may be taken by mouth at home, significantly reduces the risk of hospitalization in some COVID-19 patients at serious risk for severe illness.

The Lancet study enrolled nearly 1,500 adults in Brazil. Most study participants were unvaccinated, had symptomatic, early, confirmed COVID-19, and were at increased risk of serious illness due to underlying health problems. About half took a placebo while the other half were told to take one 100-mg fluvoxamine pill, twice a day, for 10 days.

The fluvoxamine group was significantly less likely than the placebo group (11% versus 16%) to need hospitalization or an extended emergency room stay. The randomized, placebo-controlled trial was conducted by an international team of researchers, and it confirmed preliminary findings published last year in JAMA.

Common side effects of fluvoxamine include headaches, nausea, diarrhea, dizziness, and sexual side effects. In the Lancet trial, tens of participants assigned to fluvoxamine stopped taking the drug because of side effects. In addition, because the study participants took the drug (or placebo) at home, they did not all take the medication as prescribed. But in this case, medication adherence made a difference: those who took fluvoxamine as directed on more than 80% of possible days were significantly less likely to die than those in the placebo group. But there was no significant difference between the number of people who died in the placebo group compared to the full fluvoxamine group, which included a wide range of adherence.

Fluvoxamine is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It was approved by the FDA in 1994 and is used to treat obsessive-compulsive disorder (OCD) and anxiety. Fluvoxamine appears to work against COVID by reducing inflammation, which is a hallmark of severe COVID infection. The drug may also have antiviral properties. Because it is already on the market, doctors can prescribe it off-label for COVID patients they deem appropriate.

Additional, high-quality research will hopefully reproduce the Lancet study findings and answer remaining questions. For example, will fluvoxamine help symptomatic COVID patients who are vaccinated, or those who do not have risk factors for severe illness? And, will people who already take daily fluvoxamine to treat mental health issues also gain some protection against COVID-19?

What are monoclonal antibodies? Can they help treat COVID-19?

Monoclonal antibodies are manmade versions of the antibodies that our bodies naturally make to fight invaders, such as the SARS-CoV-2 virus. There are currently two monoclonal antibody treatments that have been granted emergency use authorization (EUA) by the FDA to treat COVID-19.

The FDA-authorized monoclonal antibody treatments are sotrovimab, made by GlaxoSmithKline, and bebtelovimab, made by Eli Lilly. Both may be used to treat non-hospitalized adults and children over age 12 with mild to moderate symptoms who have recently tested positive for COVID-19, and who are at risk for developing severe COVID-19 or being hospitalized for it. EUA for bebtelovimab, which was authorized more recently in February 2022, states that the treatment should be given when “alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.” The therapies must be given intravenously (by IV) soon after developing symptoms.

Both sotrovimab and bebtelovimab appear to be effective against the Omicron variant, which was responsible for more than 99% of COVID-19 cases in the US in mid-February. In laboratory tests, bebtelovimab was also effective against the BA.2 omicron subvariant.

As of February 2022, the number of patients who would benefit from monoclonal antibody treatment far exceeds the supply and the infrastructure to deliver this therapy. Once oral antiviral medications are more available, there will be more treatment options for high-risk patients.

A different monoclonal antibody treatment may help to save lives in a specific subgroup of hospitalized COVID-19 patients. Some COVID patients get sicker because of an overreaction of the body’s immune response (a cytokine storm) to the viral infection. When this happens, the body overproduces interleukin-6 (IL-6) — a protein involved in inflammation — in lung cells. For these very ill hospitalized patients, the FDA has granted EUA for tocilizumab (Actemra), a monoclonal antibody that blocks the action of IL-6, and thereby dampens the exaggerated immune system response.

What is convalescent plasma? Does it help people with COVID-19?

When people recover from COVID-19, their blood contains antibodies that their bodies produced to fight the coronavirus and help them get well. Antibodies are found in plasma, a component of blood.

In August 2020, the FDA issued an emergency use authorization (EUA) for convalescent plasma in patients hospitalized with COVID-19. However, clinical evidence that this treatment is effective has been limited. As a result, the FDA narrowed its authorization in February 2021. Convalescent plasma is now authorized only for people who are immunocompromised, either because of a medical condition or because of a treatment that suppresses their immune system. The treatment may be given to hospitalized and non-hospitalized patients.

Who can donate plasma for COVID-19?

In order to donate plasma, a person must meet several criteria. They have to have tested positive for COVID-19, recovered, have no symptoms for 14 days, currently test negative for COVID-19, and have high enough antibody levels in their plasma. A donor and patient must also have compatible blood types. Once plasma is donated, it is screened for other infectious diseases, such as HIV.

Each donor produces enough plasma to treat one to three patients. Donating plasma should not weaken the donor’s immune system, nor make the donor more susceptible to getting reinfected with the virus.