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Developing novel therapeutics for Long COVID

Infectious Disease/Vaccines

I tried a combination therapeutic that resolved my long COVID symptoms and reversed biomarkers of cellular dysfunction.

Project Team

Rohan Dixit
Rohan Dixit

Project Status

Clinical Stage
Early Stage
Patent Status
Patent filed

Funding Opportunity

Opportunity type
Funding requested
$995,000
Funding allocated
$0

Background

After COVID-19 infections, millions have experienced long-lasting symptoms called Post-Acute Sequelae of COVID-19 (PASC), or colloquially "Long COVID." While there are a few theories about the underlying pathogenesis of Long COVID, increasing evidence shows SARS-CoV-2, the virus that causes COVID-19, continues to linger in the body and brain [1], potentially driving ongoing symptoms. 💡 The Idea 💡 If Long COVID is driven in part by persistent virus, it might be worth re-purposing therapeutics for acute COVID infection as potential PASC therapies. However, this process has been slower than many hoped. [2] As someone with long COVID since March 2020, I decided I needed to take some kind of action to address my ongoing symptoms. With excellent clinicians supervising my care, I was lucky to undergo a series of treatments that cleared my long COVID symptoms. 📝 The Experiment 📝 We discovered combining Paxlovid and Evusheld, a viral replication inhibitor and monoclonal antibody drug, respectively, over multiple treatment cycles caused a complete elimination of ongoing PASC symptoms (n=1). [1] Stein, S.R., Ramelli, S.C., Grazioli, A. et al. SARS-CoV-2 infection and persistence in the human body and brain at autopsy. Nature 612, 758–763 (2022). https://doi.org/10.1038/s41586-022-05542-y [2] "‘A slow-moving glacier’: NIH’s sluggish and often opaque efforts to study long Covid draw patient, expert ire." (2022) https://www.statnews.com/2022/03/29/nih-long-covid-sluggish-study/

Project Details

Paxlovid (nirmatrelvir + ritonavir) is a viral replication inhibitor that acts on a key viral enzyme called Mpro. Evusheld (AZD7442) is a cocktail of two monoclonal antibodies (tixagevimab and cilgavimab), administered as an intramuscular (IM) injection. It is designed as a long-acting antibody, or LAAB, that resists the more rapid elimination from the body of other monoclonal antibody (mAb) drugs like Bebtelovimab, which has a half-life of about 11 days. Evusheld's half-life is about 88 days. We used 3 treatments of combined Paxlovid and Evusheld over a three month protocol. We propose a rapid phase I clinical trial of this novel combination therapeutic. The goal of Phase I will be to assess safety and collect early efficacy data in ~15 patients, leading to larger Phase II clinical trials if successful.

Project Timeline

  • File Provisional Patents

    Required Funding$10,000
    Statusdone
    Duration3 Months

    We have filed a patent application with the USPTO that protects this novel combination therapeutic, along with a number of other promising combinations. We're placing the IP within this decentralized patient-led organization so that patients, researchers, and investors can share ownership and governance of the intellectual property going forward.

  • Clinical Trial Phase I Recruitment

    Required Funding$35,000
    Statusplanned
    Duration3 Months

    We'll work with a formal Institutional Review Board (IRB) to ensure patient privacy and safety are being adequately addressed in our proposed study design. Once we've had third-party independent review of our study safety, we'll begin recruiting patients and setting up clinical sites to assess patients and administer treatments.

  • Clinical Trial Phase I data collection

    Required Funding$850,000
    Statusplanned
    Duration6 Months

    The costs are largely driven by the cost of Evusheld and Paxlovid, and the labor of clinical personnel to deliver the treatment. While drug prices may change, Paxlovid is currently $3,600 - $5,800 per 5 day course. A 10 day course, repeated over 3 treatment sessions, would be ~$35K per patient [1]. Evusheld is approximately $2000 per course, or $6K over 3 treatments. Nurse practitioner time to safely administer treatment is estimated at ~2 hours per patient. At ~$180/hour that would be approximately $360 per treatment, or $1,080 per patient with 3 treatments. This implies a COGS of ~$42K per patient enrolled in the trial. To enroll 15 patients with a 25% study drop-out rate, we need 20 initial participants at approximately $850K in costs. [1] https://www.reuters.com/business/healthcare-pharmaceuticals/drug-price-group-slashes-suggested-price-pfizer-covid-treatment-by-80-2022-12-20/

  • Clinical Trial Phase I data analysis & publication

    Required Funding$100,000
    Statusplanned
    Duration2 Months

    We will open-source all clinical trial data, and engage with expert academics and clinicians to publish our data analysis through informal and formal publications (scientific journals, blogs, academic pre-print servers, etc.) We commit to releasing all trial data as quickly and transparently as possible, in order to provide timely information to the public and other academic researchers.