COVID-19’s Stop-Gap Solution Until Vaccines and Antivirals Are Ready

This scanning electron microscope image shows SARS-CoV-2 (round magenta objects) emerging from the surface of cells cultured in the lab. SARS-CoV-2, also known as 2019-nCoV, is the virus that causes COVID-19. The virus shown was isolated from a patient in the U.S. Credit: NIAID-RML
Image credit
This scanning electron microscope image shows SARS-CoV-2 (round magenta objects), also known as COVID-19, emerging from the surface of cells cultured in the lab. Image: NIAID-RML

As novel coronavirus cases continue to mount globally, humanity can’t turn to its go-to infectious disease fixes: vaccines and drugs. At least not yet. A new vaccine might be at least 12 to 18 months away though new drug treatments will likely come sooner. 

Arturo Casadevall, chair of the Department of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health, is helping organize a national effort to use antibodies from recovered COVID-19 patients for protection and treatments. In a March 13 Journal of Clinical Investigation article, Casadevall and Liise-anne Pirofski of the Albert Einstein College of Medicine proposed the stop-gap measure of using plasma (serum) from the blood of survivors until a vaccine and antiviral medications are available. 

In this Q&A with Global Health NOW, Casadevall says clinical trials  could begin in 3–4 weeks provided that they clear all the regulatory steps. If that happens, he anticipates widespread availability by early summer. 
    

How can plasma be useful against the novel coronavirus?
When you recover from many viral diseases, you have in your blood what are called neutralizing antibodies. These are antibodies that kill the virus. Once you recover, the plasma can be taken from donors. It’s very safe. It's the same thing as using a blood donation except they don’t take the red blood cells, they take the liquid. They take the plasma. It is itself a drug... it can be used for prevention of infection for people who are being exposed or it could be used for therapy for those who are sick. 

It’s not a vaccine. Think about it as the administration of a protein, it’s a liquid that is given to people that gives them immunity.

Right. Because the vaccine would provoke the recipient’s antibodies. You'll have the antibodies, but they won't be your antibodies—though it'll do the same thing. 
Right.

And if somebody is already sick, can the plasma help them? 
Yes, it can be used for prevention or a treatment.

This strategy is already being used in China?
Yes. In fact, the Chinese sent 90 tons of plasma to Italy.

Will this need to go through extensive testing in the US?
We have to do this right. You need to have [the protocol reviewed by officials in each institution’s review board]. And because this is an investigational drug, you need to have FDA approval to do a trial. And both documents are being sent in today [Wednesday, March 18] to the FDA and to the IRB [at the Johns Hopkins Bloomberg School of Public Health]. That's how far along we are.

You know we have gone from discussions to the FDA and the IRB in two weeks. 

How long would that normally have taken?
Many, many months.

How soon do you hope to roll this out? 
Between three and four weeks.

And what will that look like? A clinical trial? 
Once we get the approval, we can begin recruiting people for donating plasma and for the clinical trials. Donors have to donate blood that then has to be  processed before using it. I think that it is not going to help the first ones who get sick, but I think as we as we get into trouble in April, May, June, that is that this may be coming online.

Are there side-effects to using this? 
Plasma is very safe.  It is screened for bloodborne pathogens and blood typed so you don't have a transfusion reaction.  Blood transfusion is one of the most regulated industries in the United States. It's one of the safest things available.

How’s what you’re proposing compare with what the Chinese have done?
The Chinese have assumed that everybody who recovered had antibodies so they went on to use the plasma and are reporting good results although the data is not yet published. When patients recovered, they took the plasma and used it on those who needed it. We are proposing a much more sophisticated thing in which we will actually measure the virus-killing antibody in people before they donate. And we’ll use only the highest activity plasma.

You're making sure that there are antibodies in there and that they would be effective?
Exactly. Exactly—that we have a potent unit. We think that one person can treat two people.

When you say it could be ready and useful in three to four weeks— 
I'm assuming no major hurdles from the IRB or FDA, right—but everybody's in emergency mode. I mean we are headed for something we have never experienced before and I don't think anybody's going to sit there and obsess on the small details. This is the only game in town.

How will you get this out nationwide? 
Our network involves dozens of institutions. 

Obviously you wouldn’t be be producing all of this. You would be giving people the directions on how they can do this themselves? 
Johns Hopkins is sending this IRB protocol to everybody who needs it to try to expedite things. 

Other institutions wouldn't have to go through the same FDA approval, right?
Well, we are hoping that the FDA, given the emergency, grants Hopkins, one investigational new drug [IND approval] that can be used nationally . 

You launched this? 
I knew that this was potentially very helpful so I wrote an op-ed in the Wall Street Journal that gathered a lot of attention and focused many physicians.  My colleague and I then wrote a formal proposal for this option that was published in the Journal of Clinical Investigation. We basically began screaming first. And others noticed, and many groups joined. This was important and needed to be done.

It’s a good story in the middle of a plague.


Ed Notes: 

Casadevall wishes to thank Hopkins colleagues who have been working on this project including Shmuel Shalom, Evan Bloch and Aaron Tobian, Andrew Pekosz, Lainie Rutkow, Bryan Lau, Jonathan Zenilman and many others including the Office of the Provost, which supported the effort with a $250,000 grant. He also notes, “This is an all hands effort and the Hopkins community has taken on the challenge with great energy, determination and cooperation.”

For more information on this issue, listen to this episode of the Public Health On Call podcast.

For GHN's latest coverage of the coronavirus, visit here.
 
Join the tens of thousands of subscribers who rely on Global Health NOW summaries and exclusive articles for the latest public health news. Sign up for our free weekday newsletter, and please share the link with friends and colleagues: https://www.globalhealthnow.org/subscribe 

Comments +

56 comments

Joshua Rickards
March 20, 2020

There’s no mention of ADE in this article. Look it up. It’s what stopped several antibody treatment trials for things like dengue fever. Antibody treatments like this can ‘prime’ the hosts immune system and can bring on a storm of immune response that ultimately worsens the disease.
What they know about this corona virus so far is that the viral load becomes undetectable in the throat after a short time, and then the IMMUNE response in the lungs, the ‘cytokine storm’ is what kills. These and MOAB therapies will likely be a huge early misstep in the treatment of this disease.

Michael Peters
March 20, 2020

I’m convinced I had corona virus in November while on the Diamond Princess 29 day cruise. Is there a way for me to get a blood sample to see if I have levels of (corona virus killing antibodies) so that I could be a serum donor.

jerry Bucci
March 21, 2020

Any results from the 90 tons of plasma sent to Italy??

Mike Tobin
March 21, 2020

God bless health care workers and scientists.
Thanks for the brains and the bravery.
Keep up the good work.

Hector Rojas
March 21, 2020

The md from usa are heroes

Andre
March 21, 2020

Hej jeg hedder andre og jeg vil spørge om hvornår går smittet væk jeg ved godt at vi skal passe på hinanden i denne svære tider og jeg passe godt på så ikke blevet smitte med den virus for jeg har en dårlig lunge og jeg blever snart tosse at være indskærpet i bofællesskab hilsen andre

Brooke Frost
March 21, 2020

For the researchers - if people give blood (needed, regardless), will there be test available for the blood centers to test for antibodies? This could find undiagnosed or asymptomatic people. It could be a win-win.

Janet Petrine
March 21, 2020

Thank you for screaming! Your trailblazing attitude is beautiful and nobel. Americans, no humans are indebted to you and your willingness to thunder forward through the chaos.

John Mulholland
March 21, 2020

Please ADD a line for Total US deaths !!!
- you can leave the totals for states,
but we need to be able to quickly see the US total deaths !!!

Suz
March 21, 2020

1. What about using prolastin protein infusion for Covid-19 patients?
2. Have the infectious disease folks tried any of the the Alpha-1 infusion treatments for Covid-19 patients?
3. What is the process for “recovered” Covid-19 patients to donate their plasma.

Kevin
March 21, 2020

Why not start contacting, organizing and collecting plasma from the appropriate individuals now?

Bill Crownover
March 21, 2020

I had COVID-19 two weeks ago. Can I donate plasma?

Mike Rose
March 21, 2020

Thank you for your work. Once the antibodies are identified and sequenced, could the antibodies be synthesized in a scalable process so that more patients could be treated than through plasma transfusion?

Matthew Schilling
March 22, 2020

We’ll need to test for people who have already recovered without ever being identified. That must be a different test than what was just ramped up..
Also, perhaps we should be exposing young healthy people to this virus, to build up the population of immune people? Maybe we should’ve kept most college students on campus and only sent their boomer professors home.

Anna Warner
March 22, 2020

Please add to your charts (in right bottom quadrant) daily and cumulative counts by the country/territory. WHO.int map is providing this information but is completely outdated. It seems that only John Hopkins is able to keep up with the epidemic stats. Also in main quadrant you currently display infected and active cases please add also deaths.
Thank you for the efforts. Also I hope you can get more than millions dollar grant to conduct research of the vaccines and medicines. Thank you again.

Corinne Valeri…
March 22, 2020

How can people know if they’ve had CV-19, carry the Antibodies, (and can hug their children again!) if they can not get tested??????

Eli Schneider
March 22, 2020

A brighter hope

Sean E
March 22, 2020

Since these aren't our own antibodies, does that mean that the modified plasma would have to be administered more than once? Because WE aren't producing the antibodies - the antibodies are coming from the modified plasma? If so, any idea how often it would have to be administered to be effective?

Wallace Skok
March 22, 2020

This is great work. Is the CDC collaborating with Johns Hopkins and the network of other medical scientists around the country/the world on getting these trials approved on a fast track basis? I’ve read about plasma therapies in the past. Hopefully, Dr Casadeval is correct in his belief that the approval process won’t get “lost in the weeds”.

José Encina N
March 22, 2020

Informações muito relevantes.

Dr.Bertram Eic…
March 22, 2020

There are a lot of companies in europe (I e.g. was working for many years at Biotest in Germany- a well known human plasma fraktionator) with expertise in the field of manufactoring IgG concentrates against various virus deseases.
As fare as I remember (I am retiered since 2009) there would be no problem to adapt the manufactoring process to an Ab of a new virus as e.g. covid-19.

Francis J Scholz
March 22, 2020

Could the largest group of survivors indicate another solution? The death rate from children 0-9 is negligible. Could small amounts of serum from every child between 5-8 years be used as a therapy for seriously infected adults?
If true, every hospital in every country could create a therapy on site to cure the sickest patients. Serum from healthy grandchildren will cure all the grandparents.. Francis J Scholz, MD, FACR, FACG, Licensed Physician, Lahey Clinic Medical Center, Burlington, MA

Charles R. Gallagher
March 22, 2020

Thank you for this informative article. And thank you doctors, for your skill & devotion (and lack of sleep)! I like your protocols, and I like to hear that the FDA is stepping up. Let's do this the right way. Keep rocking it.

Duane Inlow
March 22, 2020

I assume the blood (plasma) donor for this coronavirus passive immunity experiment will have neutralizing and other types of antibodies against the coronavirus, but they may also have active coronavirus. Worst case: there might be mutated forms of the coronavirus that are beginning to escape the effects of the donors's antibodies. Could this proposed treatment start an early new wave of (normally) 2021 coronavirus strain infection?

kerr
March 22, 2020

is there a test to tell if you had a mild case of the virus and have the antibodies?

William Clark
March 22, 2020

More of a question: Obviously if this works, monoclonal antibodies are the way to go. Are plans in progress to do this if the initial plasma antibodies appear promising? What criteria would have to be met to to progress to that step????
Who will have proprietary rights to any positive agents produced??

Tgmc
March 22, 2020

For people that do not have the virus, can we donate blood and our plasma be used to help?

Erod
March 22, 2020

Outstanding news! I am looking forward to updates concerning progress. If you haven’t already, please make sure to reach out to ADMA Biologics in Boca Raton, FL. ADMA is the only US owned fractioning plant that sources US plasma for US patient use and has patents referencing coronavirus.

Robbyn Enriquez
March 22, 2020

Please explain the wild swings in the number of cases vs the number of deaths. Some states Show a number like 500 cases with 50 deaths. Other states show 900 cases with 40 deaths. Why the disparity?
Robbyn Enriquez

Michael W. Rub…
March 23, 2020

Thank you for all that you are doing. Please keep us posted and we will share your results and Plan with our ID colleagues, in case they miss this. We are watching closely the JHU Dashboard daily and your Global Health NOW site.

Michael W. Rubottom, M.D.
Internal Medicine
Cedars Sinai Marina del Rey Hospital
310-821-8588 Physicians line
310-702-9239 cell/txt

Charles Poole
March 23, 2020

I have been hearing for two weeks about underlieing conditions, but no one says what they are. Exactly what are these conditions?

marian Welch
March 23, 2020

thank you.

Jeffry Reidler
March 23, 2020

I would like to participate in your plasma Antibody study. I got sick 3/5 and am now fully recovered. Fever, pneumonia, and cough.

David Camorali DDS
March 23, 2020

I was in China and got really, really sick with sore throat, cough, chills and was diagnosed with atypical pneumonia in November 2019. It took 6 weeks to get over. I believe I have recovered from Covid19. I would be happy to donate blood plasma if it can possibly help other very ill people.

E. Ioanid MD
March 23, 2020

We used to call it "serum sickness" so no need to describe it further, but how frequent is it and how frequent are anti-antibodies and how do you confirm efficacy efficacy of treatment if you use it when patients have "symptoms" without clear signs other than low grade fever?
Also, clinical distinctions seem really hard to differentiate, so how do you decide from where and at what point to use this passive immunity?

Private
March 23, 2020

Thinking outside of the box;
Would a pregnant woman, who contracts the virus during pregnancy, make antibodies to fight the virus? If so, wouldn’t said antibodies be in the placenta, cord, stem cells??

Li Tian
March 23, 2020

Since we are not even testing for Antibodies against COVID19, how do we find such people who might have it, without severe symptoms, to provide such serum? Are we going to do the antibody testing soon? How about the 15 min "pregnancy testing strip style" tests? What's the proposed scale for such testing? Can we expand it to the level of what South Korea have done or even further - maybe ALL Americans? What's the timeline for that?

Claire Duvall
March 23, 2020

TRUMP gave FDA/ OK FOR USE ANY DRUG IN EXTREMIS
CHECK IT OUT...POSS NO TRIALS NECESSARY

CLAIRE
March 23, 2020

WHO IS WORKING ON VIRUS MUTATING CAUSING RE INFECTI0N IN CHINA

Harriet Mathews
March 23, 2020

It would seem that while the sophisticated upgrade of measuring antibody timers is taking place we could still employ the Chinese version. I recall in the movie Rudy, his younger brother in Acute
Lymphocytic Leukemia remission contracted chicken pox. The treatment was a transfusion from a blood type compatible donor who was recovering from chicken pox.

Jacqueline Herle
March 23, 2020

Plasmapherese could be maybe helpful?

Graham Stagg
March 23, 2020

Thank you folks. Any chance you could give total deaths in US atop a state by state breakdown.? Also, perhaps, data as a percentage of population?

Ken
March 24, 2020

I read Johns Hopkins may use blood from patients who had Covid 19.
I am sure I had it because I was in Vietnam last Nov. I left from the city of Danang where there were many Chinese tourists at my hotel. About 6 days after returning, I started having a dry cough, and joint aches. This lasted a least 15 days or more. My wife, retired RN told me to go to a doctor but I didn't. I did continue to use Dulera and a rescue inhaler. Now, a fit slim health 67 year old man. Let me know if I can be of any help.

Val Kavaleri
March 24, 2020

Young men and women 18-30 have historically been those who we send to war. In this new war, this group of adults has the lowest death rate. Can we give the serum to them first and let them go back to work? And is their blood then able to be used as a serum?

Steve Biller
March 24, 2020

Why aren't you showing recovery for the united States? This seems odd that showing for the whole country but not here.

Yogi Soni
March 24, 2020

I would like to see a graph of the number of positive cases and deaths plotted against the number of tests conducted, both by country and by US states. This can also be plotted on a per-capita basis.

Lesley Finney
March 24, 2020

Would the US be able to receive plasma from China similar to what they provided Italy? and if not why? could the plasma from China be screened to get the "best" plasma? or collected with your protocol?
Thank you.

Will
March 24, 2020

Thank you for correctly identifying the true gravity of the situation we face and for all of the tireless efforts of you and your colleagues. Good Luck.

Artemis
March 24, 2020

What about those who have immune compromised systems and already have issues with taking any live vaccines? You're talking about introducing to their system antibodies to their system that could potentially overload them. How would this affect them? They're some of the ones who are most at risk and need to be helped the most-- how would they be helped by this?

Jay
March 24, 2020

Congratulations on the good work! Sometimes less is more and traditional methods are the way to go. I wish more countries would share in this effort, namely Italy and Spain.

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