Clinical Study

Coronavirus Nomacopan Emergency Treatment For Covid 19 Infected Patients With Early Signs Of Respiratory Distress (Coronet 1)

Posted Date: Jun 29, 2020

  • Investigator: Jonathan Bernstein
  • Specialties: Pulmonary Diseases, Vascular
  • Type of Study: Drug

Extensive literature from in vivo studies indicate complement activation occurs in viral infections. Patients with severe SARS-CoV-2 pneumonia (SC2P) have elevated serum C5a (Goa T. et al medRxiv preprint doi: posted April 7, 2020). Autopsy studies found complement components including the terminal pathway effector C5b-9 associated with pulmonary thrombotic microangiopathy (TMA) and systemic vessels (Magro c. et al. Transl Res. 2020 Apr 15: S1931-5244(20)30070-0. PMID: 32299776; PMCID: PMC7158248.). This is associated with an endotheliitis and angiogenesis (Ackermann M, May 21, 2020, at DOI: 10.1056/NEJMoa2015432). Use of an inhibitor of C3 to treat 4 SC2P patients led to recovery over 4 days (Mastaglio S. et al. Clin Immunol. 2020 Apr 29; 215: 108450. PMID: 32360516; PMCID: PMC7189192.). Similarly, a C5 inhibitor resulted in a similar speedy recovery (Diurno F et al. European review for medical and pharmacological sciences. 2020;24(7):4040-4047. doi:10.26355/eurrev_202004_20875). Nomatopan a recombinant protein uniquely blocks the conversion of C5a to C5b-9. It is effective in treatment of TMA after human stem cell transplants HSCT) for which it is entering phase III trials. Along with C5a inhibition it has associated LTB4 inhibition that should specifically restore regulation of the terminal complement pathway and reduce general inflammation. COVID-19 people without symptoms and those without evidence of pneumonia will not be considered for treatment. The primary objectives are: 1. Reduction or recovery from lung damage associated with SARS-CoV-2 pneumonia; 2. To determine the safety of use of nomacopan in SARS-CoV-2 patients. The secondary objectives are:1. To determine if the recovery from COVID-19 pneumonia is accelerated by the treatment; 2. To determine if the progression to ARDS and a need for assisted ventilation is avoided; 3. To determine if the mortality risk is reduced; 4. To determine if hospitalization duration is reduced.


The Inclusion Criteria Are: 1. Aged > 18 To 80; 2. Between 50 And 100Kg In Weight; 3. Admitted To Icu Or Covid-19 Unit With Suspected Covid-19 Pneumonia With Spo2 < 93% Breathing Air, But Not Receiving Ventilation By Intubation, So That Patients Receiving Either Cpap Or Bpap Can Be Included; 4. Able To Provide Informed Consent Or To Have Informed Consent Given By A Legally Appointed Representative. The Exclusion Criteria Are: 1. Patients Receiving Other Specific Anti-Complement E.G. Eculizumab In The Last Three Weeks Or Anti-Cytokine Drugs E.G., Tocilizumab In The Last Week. Corticosteroids, Antibiotics And Hydroxychloroquine Will Be Permitted. In Case Of Doubt, To Be Discussed With The Sponsor’S Medical Representative; 2. All Patients Will Also Be Permitted To Receive Appropriate Antiviral Therapy As Defined By Local Covid-19 Protocols, E.G., Remdesivir; 3. Pregnancy Confirmed On A Negative Urine Test (Or Blood Test If Anuric); 4. Enrolled In Another Investigational Trial; 5. Vulnerable Populations


Covid 19, Nomacopan, Respiratory Distress

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Jonathan A. Bernstein