These include:
Remdesivir
Remdesivirwas initially developed as a treatment againstEbola.
In contrast, the World Health Organization (WHO) found no clinical benefit in their Solidarity trial.
This study included nearly 11,300 hospitalized people with COVID-19 across 30 countries.
Geber86 / Getty Images
Study participants received one of four treatments: hydroxychloroquine, interferon, lopinavir-ritanovir, or remdesivir.
None of the treatments decreased the mortality rate over 28 days or the need to start ventilator therapy.
Since that time, WHO has formally advised against using the drug for hospitalized patients.
A three-day course of treatment is recommended in these cases.
Dexamethasone and Methylprednisolone
Dexamethasone and methylprednisolone are steroids that are often used to treat inflammation.
They come in both oral and IV formulations.
Steroids have shown benefits when used in combination with tocilizumab (see “Biologics” section below).
Steroids decreased mortality by 34%, but the mortality rate decreased by 56% when combined with tocilizumab.
In the study, 111 children with the syndrome were treated with IV immunoglobulin with or without methylprednisolone.
The investigational treatment includes two antibodies targeted against COVID-19.
People who received the cocktail (n=186) did not develop symptomatic infections, although 10 developed asymptomatic infections.
The placebo group (n=223), however, developed 8 symptomatic infections and 23 asymptomatic infections.
The treatment was 81% effective in decreasing symptomatic infections.
In July 2021, the FDA authorized the treatment for post-exposure prophylaxis.
By January 2022, the majority of COVID-19 cases in the U.S. were attributable to the omicron variant.
Unfortunately, REGEN-COV2 has not been as effective against this version of the virus.
Other Synthetic Antibodies
The following COVID-targeted antibodies are listed in order of their development and use.
A Phase 3 trial treated 769 COVID-19 patients with the monoclonal antibody combination or placebo.
Altogether, the bamlanivimab-etesevimab combination decreased the risk for hospitalization or death by 87%.
In a January 2021 press release, Eli Lilly reported the effectiveness of bamlanivimab as a preventive therapy.
Over eight weeks, those treated with bamlanivimab were 57% less likely to develop symptomatic COVID-19.
Four people died from their infection, but none of them were in the treatment group.
The treatment is intended for non-hospitalized patients with mild-to-moderate COVID-19 symptoms who do not require supplemental oxygen.
Unfortunately, combination therapy with bamlanivimab and etesevimab has not been as effective against this version of the virus.
Bamlanivimab and Virus Variants
Virus variants have had increasing resistance to bamlanivimab.
For this reason, the Department of Health and Human Services no longer distributes this treatment on its own.
It was authorized for combination treatment with etesevimab for a time.
Their Phase 3 trial included 583 people at high risk for hospitalization from COVID-19 infection.
Emergency use authorization was granted by the FDA on May 26, 2021.
BRII-196 and BRII-198
Brii Biosciences has developed a combination of monoclonal antibodies, BRII-196 and BRII-198.
Bebtelovimab
Eli Lilly has continued to develop monoclonal antibodies against COVID-19, specifically the Omicron variant.
Vaccines Against COVID-19
The best hope for managing COVID-19 long-term: vaccines.
The goal is to make antibodies against the virus without causing an infection.
Hopefully, your immune response will be so strong you won’t get sick at all.
The vaccine is administered in a two-dose series, three weeks apart.
Vaccination of nearly 600,00 people in Israel has shown results similar to those in the Pfizer clinical trials.
A U.K. case control study also looked at the effectiveness of vaccination in the real world.
After a second dose, effectiveness increased to 85% to 90%.
Their analysis included 463 residents in Connecticut nursing homes where there was an outbreak of COVID-19.
Children:
Myocarditis
TheCDC reportsa small increase in myocarditis cases with use of the mRNA vaccines.
The rates were higher for the Moderna vaccine than the Pfizer vaccine.
Still, the risk for myocarditis remains very low, and most people tend to recover quickly.
In July 2022,full approval was granted for ages 12 to 15.
The vaccine remains under an emergency use authorization for children and adolescents 6 months to 11 years old.
Everyone ages 6 years and older can choose to get the Pfizer or Moderna bivalent booster.
One dose was 93% effective against COVID-19 after 14 days.
Effectiveness increased to 100% two weeks after the second dose.
Four COVID-19 cases were detected in the placebo group.
Due to concerns for myocarditis, there was a delay in FDA approval.
Currently, there is an emergency use authorization in place for anyone 6 months and older.
Approval:The FDA granted the Moderna vaccineemergency use authorizationon December 18, 2020.
TheFDA granted full approvalfor the two-dose mRNA vaccine series in January 2022.
Now called Spikevax, the Moderna vaccine is approved for people 18 and older.
It is an adenovirus-vectored vaccine that attacks the spike protein expressed by SARS-CoV-2.
Their Phase 3 trial included more than 43,000 people, and there were 468 cases of symptomatic COVID-19.
Of note, 95% of the cases in South Africa were from the B.1.351 variant.
In September 2021, Johnson & Johnson released real-world data involving more than 390,000 people vaccinated with one dose.
The vaccine was75% effective against severe COVID-19overall.
In December 2020, AstraZeneca published peer-reviewed data on more than 11,000 study participants across two different study trials.
Interestingly, efficacy was also affected by the timing of the doses.
The researchers looked at approximately 157,000 people who were tested for COVID-19 in the real world.
Overall, there were 141 cases of symptomatic COVID-19.
Novavax Inc.
Overall, effectiveness of the vaccine was 89.3%.
This broke down to 95.6% against the original strain and 85.6% against the British variant.
A bacterial vector is used to infect a specific punch in of plant,N.
The plants are then allowed to grow until enough vaccine material is grown.
They are then harvested, and the vaccine material is extracted and isolated.
Efficacy:The companies released a press release in December 2021.
INOVIO Pharmaceuticals Inc. ## Biologics
Severe cases of COVID-19 have been associated with what is called a cytokine storm.
In some cases, however, that process becomes hyperresponsive, and excess cytokines are released.
Some of these cytokines are inflammatory in nature and can lead to worsening of respiratory symptoms or organ failure.
Biologic agentspharmaceutical treatments created from biological sourcesare now being considered to address this.
Approximately 1,000 patients hospitalized with COVID-19 were randomized to receive remdesivir alone or remdesivir with baricitinib.
On average, patients clinically improved one day earlier with the combination treatment.
It remains on an emergency use authorization for children 2 to 18.
Interferon Beta-1a
Interferonsare a natural part of your immune system.
These cytokines boost the immune response to viruses.
Currently, interferons are currently an injected treatment used for viral hepatitis.
Participants were treated with inhaled interferon beta-1a via nebulizer or placebo for 14 days.
Three studies were published inJAMA Internal Medicinein October 2020, but the results were inconsistent.
The former study looked at 130 people with moderate-to-severe disease, and the latter at 126 people.
Although clinical outcomes were improved, mortality rates did not significantly change.
Unfortunately, not all studies have shown a benefit.
At 15 days, mortality was actually higher for those treated with tocilizumab, 17% vs. 3%.
At 29 days, mortality rates were not statistically significant between the two groups.
Although other studies have shown a survival benefit, this study raises significant issues for safety.
In fact, this study was terminated early for that reason.
That said, tocilizumab should not be used for people who are significantly immunocompromised.
The FDA granted an emergency use authorization for tocilizumab as a treatment for COVID-19 on June 24, 2021.
It is intended for hospitalized patients 2 years and older who have severe COVID-19.
When we are exposed to a foreign substance like COVID-19, our immune system can develop antibodies against it.
Blood that contains these antibodies is referred to as convalescent plasma.
The researchers estimated only seven seniors would need to be treated to decrease severe illness in one adult.
Not all research has been as favorable.
Only high-antibody-titer convalescent plasma was authorized for use.
A randomized, controlled trial inNature Medicinewas published in August 2021.
Molnupiravir
Molnupiraviris an oral antiviral medication that does not target the spike protein like the vaccines do.
Instead, it is a drug that blocks the replication of some RNA viruses.
The drug has been developed byMerckandRidgeback Biotherapeutics.
that increased the risk for a bad outcome.
Updated data was presented to the FDA in November 2021 that included 1,433 adults.
The effectiveness remained high but was lower than previously reported, 30% instead of 50%.
The FDA granted EUA for molnupiravir in December 2021.
Treatment should begin within five days of symptom onset.
Paxlovid (PF-07321332 and ritonavir)
Paxlovidis a new antiviral regimen developed by Pfizer.
It is a combination of two medications, PF-07321332 and ritonavir.
PF-07321332 prevents replication of the virus by blocking the SARS-CoV-2-3CL protease.
The ritonavir does not attack the COVID virus directly.
After 28 days, only 3 out of 389 people treated with Paxlovid required hospitalization and none died.
The placebo group had 27 hospitalizations out of 385 people and 7 died.
When treatment was given within five days of symptoms, results remained strong.
Altogether, the effectiveness of treatment is estimated to be 89%.
The FDA granted emergency use authorization for Paxlovid in December 2021. who had been exposed to the virus.
Sabizabulin
Sabizabulin is a medication developed by Veru Inc.
It works by impairing the ability of the SARS-CoV2 virus to move within cells.
It does this by interfering with the formation of microtubules that transport the virus throughout your cells.
Influenza Medications
Favipiravir and arbidolare antiviral medications used to treat influenza.
In high concentrations, they may be effective against COVID-19.
Both medications were well-tolerated with only mild side effects.
Ivermectin
Ivermectinis a medication currently FDA-approved for treatment of certain parasitic infections.
In animals, it is used to treat heartworm and other parasitic diseases.
Researchers are looking to repurpose this medication as an antiviral medication.
What the Research Says:
Ivermectin as a treatment for COVID-19remains controversial.
In those cases, individual cells are infected with the virus and are treated with the medication.
This may sound promising, but there is concern about the dose needed to achieve this effect.
Viral replication is not affected until a certain dose is reached.
There has not been much benefit seen for people with mild to moderate disease or for preventing infection.
It is important to note that the quality of available studies is low.
In many studies, other COVID-19 treatments that patients received are not taken into account.
This makes it harder to tell which medication truly had the desired affect.
Many of the available studies are also not registered as clinical trials.
At this time, the FDA does not recommend ivermectin for treatment of COVID-19.
Lopinavir-Ritonavir
Lopinavir-ritonaviris a pair of antiviralmedications used to treat HIVthat may be effective against COVID-19.
A French study led the way in hydroxychloroquine and chloroquine research.
It initially included 26 COVID-19 patients treated with a hydroxychloroquine regimen and 16 untreated control patients.
Unfortunately, subsequent studies have not shown the same benefits.
More concerning are the potential side effects from these medications.
Not all reports are bad.
A study has been released that shows potential benefits for hydroxychloroquine in the treatment of COVID-19.
When hydroxychloroquine was combined with azithromycin, mortality was 20%.
The FDA does not recommend treatment with hydroxychloroquine or chloroquine for treatment of COVID-19 at this time.
We must stay vigilant when it comes to vetting what works and what does not.
Treatments need to be proven safe and effective before we use them to treat large parts of the population.
For the most recent updates on COVID-19, visit ourcoronavirus news page.
2020;30(3):269271. doi:10.1038/s41422-020-0282-0
U.S. Food & Drug Administration.FDA Approves First Treatment for COVID-19.
October 22, 2020.
2020;370:m3379.
October 22, 2020.
Food and Drug Administration.Coronavirus (COVID-19) update: FDA approves first COVID-19 treatment for young children.
The RECOVERY Collaborative Group.Dexamethasone in hospitalized patients with COVID-19.N Engl J Med.
Regeneron Pharmaceuticals, Inc.Regeneron Reports Positive Interim Data with REGEN-COVTM Antibody Cocktail used as Passive Vaccine to Prevent COVID-19.
January 26, 2021.
Regeneron Pharmaceuticals, Inc.FDA EXPANDS AUTHORIZED USE OF REGEN-COVTM (CASIRIVIMAB AND IMDEVIMAB).July 30, 2021.
January 24, 2022.
Lillys bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19.
Eli Lilly and Company.
March 10, 2021.
Eli Lilly and Company.
January 21, 2021.
U.S. Food and Drug Administration.
January 24, 2022.
Food and Drug Administration.FDA updates sotrovimab emergency use authorization.
Brii Biosciences - Breakthrough innovation & insight.
August 25, 2021.
Food and Drug Administration.FDA announces bebtelovimab is not currently authorized in any us region.
Centers for Disease Control and Prevention.Staying up to date with COVID-19 vaccines.
Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds.
U.S. Food and Drug Administration.
December 9, 2021.
Coronavirus (COVID-19) Update: FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine.
U.S. Food and Drug Administration.
January 3, 2022.
FACT SHEET for HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS).
U.S. Food & Drug Administration.
October 12, 2022.
Food and Drug Administration.Coronavirus (COVID-19) update: FDA limits use of Janssen COVID-19 vaccine to certain individuals.
2021;384(20):1899-1909. doi:10.1056/NEJMoa2103055
Novavax COVID-19 vaccine, adjuvanted.
U.S. Food and Drug Administration.
INOVIO Pharmaceuticals.INOVIO reports FDA partial clinical hold for planned phase 2 / 3 trial of COVID-19 vaccine candidate INO-4800.
2021;384(9):795-807. doi:10.1056/NEJMoa2031994
Kinase Inhibitors | COVID-19 Treatment Guidelines.
National Institutes of Health.
August 8, 2022.
Food and Drug Administration.Eli Lilly and Company authorization of baricitinib.
2020 Aug;2(8):e474-e484.
2021;73(2):e445-e454.
2021;372:n84.
doi:10.1136/bmj.n84
Interleukin-6 Inhibitors | COVID-19 Treatment Guidelines.
December 16, 2021.
National Institutes of Health (NIH).
March 2, 2021.
October 1, 2021.
November 5, 2021.
Pfizer.Pfizer Shares Top-Line Results from Phase 2/3 EPIC-PEP Study of PAXLOVIDTM for Post-Exposure Prophylactic Use.
April 29, 2022.
April 11, 2022.
2020;3(4):e208857.
