My beef with Long Covid trials

I'm still in disbelief and pissed off

(Image credit: NIH)

As some of you know, I recently had a very traumatic experience at the intake session for one of NIH’s RECOVER Long Covid clinical studies back in 2024. While the administrators of my particular study were just contractors for NIH, the experience still speaks volumes about the principles that NIH follows vis-a-vis Covid and airborne viruses (or rather, lack thereof). Instead of explaining the whole situation again, I will share the email exchange with the company (redacted for privacy and safety) after my recent intake appointment. It’s clear that the NIH (and many of its contractors) do not actually care about Covid or Long Covid - the very thing they are studying. To them, it is purely abstract. They willfully ignore the mechanisms of transmission and the reality that the virus has killed over 1.2 million Americans and will continue to disable and kill more and more people every single week. They don’t care about the fact that their studies to help find solutions and a cure to this horrible illness may actually perpetuate the transmission and spread of the exact virus they are trying to study and make people sick or even sicker than they already are.

The NIH’s stated goals are:

-to foster fundamental creative discoveries, innovative research strategies, and their applications as a basis to advance significantly the Nation’s capacity to protect and improve health;

-to develop, maintain, and renew scientific human and physical resources that will assure the Nation’s capability to prevent disease;

-to expand the knowledge base in medical and associated sciences in order to enhance the Nation’s economic well-being and ensure a continued high return on the public investment in research; and

-to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science.

I think it’s safe to say that through its practices relating to the RECOVER trials, the NIH is willfully standing in the way of its own goals.

My email following the intake appointment

Hi [President of the research company conducting the RECOVER trial in my area],
I wanted to write to you to share a very troubling and concerning experience I had today at my intake appointment for one of the clinical trials [your company] is helping to administer in *********.

I personally have Long Covid and am very immunocompromised. I came into the appointment assuming that since this was a study on Long Covid, the team in the office would be adequately trained on the dangers and long-term effects of Covid (as well as the vulnerability of such patients) and on taking appropriate precautions to protect the trial participants.

When I walked into the office today, I noticed that the nurse (I'm not exactly sure her title) attending to me was not masked and was also coughing. Though I assumed everyone would be wearing a high quality respirator since the study participants presumably all have Long Covid and are immunocompromised, she was not. She started coughing, so I asked her if she could wear a mask and she told me, "Don’t worry it’s not Covid…it’s just pneumonia." This staff member chose to come into the office while sick, without a mask, and interact with immunocompromised patients like me (I was wearing a N95 mask the entire time). I don't think I need to explain to you how vulnerable Long Covid individuals already are, so to say that this is unacceptable is an understatement.

She proceeded to grab a box of surgical masks (which as [your company] should know are highly ineffective at preventing the spread and transmission of airborne viruses like Covid or pneumonia compared to N95s) and tried to hand me one. I indicated to her that I was already wearing a very high quality mask (N95), and the request was for her since she admitted she was sick and was not wearing a mask. I asked if she had any other higher-quality masks to wear so that I and other trial participants would be protected and she said no. I offered her a sealed KN95 mask, but she refused to take it.

Subsequently when I spoke to [the study coordinator], who was also unmasked when coming into the room I was in, she did put on a N95 respirator at my request which I appreciated (but this revealed that there were indeed more effective, NIOSH-certified masks present in the office despite the staff member saying otherwise) and acknowledged my concerns about safety. She said that that staff member would not be working with me, however, I am still utterly shocked at my experience this morning and am fearful for other trial participants' health.

Ethically, I have a very difficult time being part of or supporting a clinical trial expressly designed to study Long Covid that puts Long Covid individuals like me further at risk with repeated Covid infections or exposure to illnesses like pneumonia because no staff member is masking, there are no visible HEPA air filters in the space, and staff members are coming in with clear symptoms of illness.

The Americans with Disabilities Act guarantees my safety as a disabled person, pursuant to my right to “full and equal access” to health care services under federal law (28 C.F.R. § 35.151 (Title II); 28 C.F.R. Part 36, Subpart D (Title III)). The ADA protects people who are immunocompromised per the ADA Amendments Act of 2008. I hope [your company] can take health precautions more seriously to comply with the ADA.

I'm not only writing on my behalf, but on behalf of all the study participants with Long Covid who are too scared to speak up and ask for the precautions they require and deserve, and who expect to be treated with respect and the appropriate precautions as to not make them further immunocompromised, disabled, or worse. A Long Covid clinical trial exists to find solutions, not to make people sicker.

I would greatly appreciate hearing your response to this experience and to understand how [your company] will do better going forward. If my safety cannot be guaranteed, regrettably I will have to withdraw my participation and also notify the NIH of the failures to keep these trial participants safe.

Respectfully.

Troubling, to say the least.

Their response to my letter

Hello [name redacted],

Thank you for your interest in our Long Covid study and reaching out to express your concerns about patient safety protection at [our company].

I reviewed your experience with our team. I apologize that our staff joked that she had bronchitis or pneumonia. [Our company]'s policy is that we are not permitted to come to work if we have flu, Covid or any infectious disease. Our staff had dry cough lately, but she didn't have flu, Covid, or any other contagious disease. We reviewed our policy again together and we discussed and trained appropriate conversation between us and our participants to make sure it is a safe and comfortable environment for our participants.

Regarding masking, we go by hospital guidelines. Right now, the hospital doesn't require masking in general. However, we should have known that you have [other less serious condition] and are vulnerable to infection. We have reeducated all our staff that we must wear N-95 mask when seeing you from now on and all other vulnerable patients.

Thank you very much for returning the study device. We appreciate that you are serious and are very compliant with the study. You passed the screening. If you decide to proceed, which we hope you will, you will visit our office twice for the rest of the study and phone calls in between. Again, when you are in our office, our staff will wear N-95 and gloves, as well as sanitize the room for you.

Suffice it to say, I found their response woefully inadequate. Keep in mind that the president of this company conducting the study on behalf of the NIH is a registered nurse and has a health-related masters degree.

My response to their reply

Hi [President],

Thank you for taking the time to reply.

For the record, I firmly do not believe the staff member was joking based on my interaction with her and exactly what (and how) she told me, but regardless, we were in a hospital setting for a clinical study for a debilitating illness. Her admission was completely unprofessional, even if it was a "joke."

To your second point about masking, I understand that hospital guidelines do not stipulate masking, but you are a healthcare professional overseeing a Long Covid study. As a registered nurse, I am sure you are well aware that Covid is airborne, that this virus has killed over 1.2 million Americans, and that nearly 23% of Americans are now estimated to have Long Covid. Researchers estimate that between 30-50% of Covid cases are asymptomatic. A recent study found that "stopping universal masking and SARS-CoV-2 testing was associated with a significant increase in hospital-onset respiratory viral infections relative to community infections. Restarting the masking of health care workers was associated with a significant decrease."

By not having staff members mask for the administration of this particular clinical trial, your team is potentially directly contributing to the ongoing pandemic (that the NIH is paying you to study) and the potential disabling and death of individuals who are volunteering to help find solutions to this grave illness. The irony of not masking for a Long Covid clinical trial is frankly shocking and hard to understand, especially when it has been proven time and again how effective it can be. It shouldn't matter what a hospital says when it has been well established by public health experts globally that taking precautions like masking with high-quality respirators, having staff members stay home when sick, and using high-grade air filters can make a huge difference for everyone's safety and prevent the further spread of Covid.

When it comes to my particular case, it is in fact of no relevance to my "vulnerability" that I have [other, much less serious condition referenced in their email]. The fact alone that I have Long Covid makes me immunocompromised - as dozens of studies will indicate. I am sure many of the participants in this study also have Long Covid and thus are similarly immunocompromised. However, even if I were a fully "healthy" participant, I would expect all [your company’s'] staff to mask for a Long Covid study, because not doing so demonstrates a complete disregard for established scientific and medical knowledge on Covid and airborne transmission, directly contributes to said Covid transmission, and flies in the face of the purpose of the NIH RECOVER trials.

For a second Long Covid clinical trial that I’m (still) enrolled in (which is sponsored by the DoD 🤮) but also contracted out to a research company, I went to a follow up visit last year.

I spent an hour telling the attending doctor about all my (70+) Covid/LC symptoms including brain damage, cognition issues, speech issues, memory loss, extreme fatigue, and more.

It was a 4.5 hour intake session and he kindly offered me some cookies because he knew it was grueling for someone with LC and ME/CFS.

I thanked him, but told him that unfortunately I don’t take off my respirator indoors. He looked confused and then proceeded to ask me why I mask.

I told him that it’s because I have Long Covid (duh) and don’t want to risk getting sick and making it worse, but inside I was fuming. I wanted to scream at him. I wanted to tell him, “You know that airborne virus that you’re researching? The one that disabled me and could disable me further? Yeah that’s why I mask! Because look what it’s done to me! It’s ruined my life. It’s ruined the lives of the other study participants you’ve met. We know it’s airborne…why would I risk reinfection?”

Only minutes before I had just finished listing out 20+ life changing symptoms and he was wondering why I wear a mask.

He was wearing a N95 (at my request) but his question made me realize that the moment he left that office, he would take it off and stop caring.

My hypothesis was correct. Despite asking in writing for everyone at the study to wear N95s and turn on the air purifiers in all the rooms, every time I came for a follow up visit, I walked in and no one was masked. When they saw me with my N95 and embarrassed, went to get their own, many put on surgical masks (despite me explaining previously that those masks do not adequately protect against airborne particles). It was clear that the researchers and doctors involved in this study also don’t understand and maybe don’t care.

I would venture a guess that most of the Long Covid studies going on in the world right now are similar.

It will never cease to amaze me how much the medical professionals and scientific researchers (including in my own family) that I interact with only see Covid and Long Covid as an abstraction. I can lay out all the ways the virus destroyed me, but they still don’t think it’s “real.” Maybe the invisibility of my illness doesn’t make it seem real enough for them. I hope they never have to find out for themselves…

My thoughts on all this

Obviously, I cannot say with certainty that the views and behaviors of these particular companies carrying out studies reflect those of the NIH (who is leading the RECOVER trials and studies) and the DoD (which is leading some other LC studies), but in my mind (and after having read Carl Zimmer’s book, “Air-borne,” it actually probably does reflect their views/understanding of Covid) the lack of NIH-directed protocols for these trials to have all staff and participants mask, for there to be air purifiers in the shared spaces of these trials, and to take whatever other precautions necessary to keep volunteer participants safe is disappointing and concerning.

To me, it’s almost akin to participating in a study on HIV and the participants being forced to have unprotected sex at the appointments. Sorry that’s graphic and I certainly do not mean to offend, but by not implementing protections for both staff and trial participants, the NIH is putting everyone at risk to contract the illness they are trying to solve. Just like during the HIV/AIDS crisis, public health officials are ignoring the realities of a mass disabling event, as well as the potential (and reality of) mass fatalities. It’s incomprehensible that this irony is not understood by the “1000+ researchers and clinicians” that are part of the RECOVER trials, or by the “1000+ Long COVID community members” that contributed to the study set up (though I know countless longhaulers who still don’t mask - which is also troubling).

As I’ve written about before on this Substack, the government (and particularly its public health institutions and officials) have a huge role to play here (which they have clearly abandoned, even and especially under Biden), but there is also a level of personal responsibility missing from healthcare providers and practitioners who should really know better. All clinical trials should have protocols not to make their participants sick or sicker than they already are, but especially a Long Covid trial. Considering that there are at least 30,000 participants enrolled in the RECOVER trials, the NIH, DoD, and its sub-contractors must recognize that they are putting me and thousands of other Americans (from staff and medical professionals involved in the trials, to trial participants themselves) more at risk for either developing Long Covid, exacerbating our already existing Long Covid, or worse, death.

Our scientists and doctors MUST do better. Their inaction, misinformation, and miseducation has already led to the death of millions. Their negligence will lead to the disabling of millions more.

👩‍🔬🔎🩸🧬 That being said, if you are a Long Covid patient, absolutely check out Ezra Spier’s amazing resource: https://longcovidstudies.net/ (a comprehensive list of all ongoing LC studies). The Sick Times also often publishes notices for LC trials that are recruiting in their newsletter, as does Solve ME in their newsletter.

If you are signing up for a trial (particularly in the US), I’d recommend putting the following request in writing (I email about a week ahead of the appointment) to help ensure your safety and health at your visits (feel free to adjust as needed):

I have a medical condition that, according to the CDC, makes me high risk for severe Covid outcomes. For my in-person appointments, I am requesting reasonable accommodation in the form of 1) N95 masking by anyone who enters the exam room, 2) a HEPA filter in any exams rooms that I will be in, and 3) no symptomatic staff members present in the exam room, as guaranteed by the Americans with Disabilities Act for safe healthcare, pursuant to my right to “full and equal access” to health care services under federal law (28 C.F.R. § 35.151 (Title II); 28 C.F.R. Part 36, Subpart D (Title III)). The ADA protects people who are immunocompromised per the ADA Amendments Act of 2008. Thank you in advance for confirming if the office can accommodate me! It's deeply appreciated.

Do not be afraid to stick up for your rights and your health. We all know that if they get you sick, they certainly won’t be paying your medical bills.

Note: Most of my writing is stream of consciousness, mostly because I’m too tired and brainfogged with my LC and ME/CFS, but also because it’s a nice experiment to be (mostly) unfiltered. Thanks in advance for excusing any typos, spelling mistakes, etc.