The New Covid-19 Treatments in Development

Here is a fresh look at the promising COVID-19 Treatments that are under development.

As the world remains in the grip of the SARS-CoV-2 virus (aka Covid-19) and scientists, physicians, and public health experts persist in their efforts to understand the virus and its clinical impact, several promising Covid-19 treatment options have emerged. Below is an overview of a few of these treatments:

Convalescent Plasma as Covid-19 Treatment

This treatment uses the plasma of recovered SARS-CoV-2 patients to take advantage of the antibodies generated by infected patients. The Mayo Clinic is the lead institution of an Expanded Access Program supported by the U.S. Government to treat COVID-19 patients across the nation. It uses antibodies to fight the infection and it’s repercussions. Treatment with this antibody-containing plasma can improve recovery time. Additional information about the program can be obtained by e-mailing uscovidplasma@mayo.edu.

Another effort is the National COVID-19 Convalescent Plasma Project—a physician-led collaboration across 57 institutions in 46 U.S. states, which went live in March 2020. The list of participating institutions is here.

However, not all clinics are testing the antibody concentration in the plasma or only administering plasma with high antibody concentrations. The results, therefore, have been mixed:

• A trial across 7 medical centers in China among 103 patients with severe or life-threatening COVID-19 did not see a statistically significant reduction in time to clinical improvement with the addition of convalescent plasma to standard treatment over a 28-day follow-up period. The trial had several caveats:
  •  It was stopped early, which could have “underpowered” the study and affected data interpretation
  • In an accompanying commentary, experts point out that the median age of trial patients was 70 years and they had severe disease, which may have affected the significance of any improvements observed
• When physicians at the Houston Methodist hospitals transfused 25 COVID-19 patients who had severe disease with convalescent plasma, the condition of 19 (76%) patients improved, or they could be discharged, by day 14. All patients received concurrent hydroxychloroquine and azithromycin. It is important to note that hydroxychloroquine and azithromycin have now been shown to not benefit, or even harm, some patients. Based on their findings, the authors deem convalescent plasma a safe and effective treatment option for COVID-19.

Antiviral Agents as Covid-19 Treatment

Several antiviral agents previously developed against other viruses are being tested against SARS-CoV-2:

• Remdesivir: This antiviral drug is being simultaneously evaluated in different patient populations:
  • Adult patients:
    • Phase 3 results from the SIMPLE trials conducted in hospitalized adults with moderate COVID-19 found that a 5-day course of remdesivir plus standard of care (an established treatment) improved patient status by day 11 compared to standard of care alone.
    • REMDACTA trial will be evaluating remdesivir with and without an anti-inflammatory drug, tocilizumab, in adult patients with severe COVID-19 pneumonia. Trial enrollment began in June.
  • Pediatric patients: A phase 2/3 trial is studying the drug in patients under 18 years hospitalized for COVID-19.
• Remdesivir is currently administered intravenously; it is also being developed as an inhaler. The price of the 5-day course is:
  • $2,340 for patients enrolled in government-sponsored insurance
  • 3,120 for patients enrolled in private insurance
• EIDD-2801: Phase 2 studies of EIDD-2801 began in June in two settings:
  • Recently symptomatic, newly diagnosed patients at home
  • Hospitalized patients with COVID-19

   The drug is being developed as a pill.

Antibody Covid-19 Treatment

Antibodies that target the SARS-CoV-2 virus can boost the body’s antiviral response and speed up recovery time. Experts believe that most patients with the infection who are younger and do not have comorbidities (such as heart disease, diabetes, cancer, etc.) will recover without treatment, so the antibodies should be tested in patients most likely to benefit from early antibody therapy. Here are some antibodies under development:

• REGN-COV2: This antibody cocktail is being studied in the following populations:
  • Hospitalized COVID-19 patients
  • Non-hospitalized symptomatic COVID-19 patients
  • Uninfected but at a high-risk of exposure (e.g., healthcare workers or first responders)
  • Uninfected people with close exposure to a COVID-19 patient
• LY-CoV555: A Phase 1 trial has been initiated for this antibody that has its roots in a blood sample from one of the first patients in the U.S. to recover from COVID-19. Following these Phase 1 safety studies, the antibody will be administered to non-hospitalized COVID-19 patients. Studies are also being planned to test the antibody’s ability to protect vulnerable individuals from getting infected.

As treatment data accumulate, guideline recommendations keep changing. The National Institutes of Health recently updated its COVID-19 treatment recommendation to include the anti-inflammatory agent dexamethasone in the treatment regimen for patients who are:

• Mechanically ventilated 
• Who need supplemental oxygen but are not mechanically ventilated

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Additional Resources

1. NIH COVID-19 treatment guideline updates: https://www.covid19treatmentguidelines.nih.gov/whats-new/.
2. FDA’s daily updates on COVID-19: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19#new.
3. CDC guidance on clinical management of COVID-19 patients: https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html.

 

RISKS TO THE IMMUNOCOMPROMISED

Please support renewed efforts to practice social distancing, mask wearing and hand washing. If you need a reason, read this… https://patientsrising.org/the-risk-of-reopening-pandemic-life-for-the-chronically-ill/ and watch the video.

FINDING INSURANCE IF YOU LOST IT DURING COVID

If you have lost your employer-sponsored health insurance here is some information that can help you find a replacement… https://patientsrising.org/health-plan-for-the-unemployed/ .

Patients Rising University acknowledges the important contributions of Surabhi Dangi-Garimella, Ph.D. in this article. Improving patient access is our mission and we’re happy to utilize a variety of experts to carry that out.