Dr. Daniel Lucey, who has responded to, and monitored information on outbreaks since 2001, has provided a series of updates and analysis on the outbreak, now linked global epidemics of COVID-19. He continues to respond to and break down developments and data on the continued spread of the virus. He has just returned from a trip to Shanghai, Hong Kong and Egypt. This is his 13th update on questions raised by the continued spread of, and responses to the virus that causes COVID-19.
When did China’s National Health Commission issue its latest (version # 7) official guidance on “Diagnosis and Treatment of Novel Coronavirus Pneumonia (NCP)?
March 3 (and posted March 4) 2020.
Are IgM and IgG antibody diagnostic criteria included in this latest guidance?
Yes. The google-translation of the guidance link states: “In the confirmed cases, a “serological test” was added…that is, “new coronavirus-specific IgM antibodies and IgG positive” or “new coronavirus-specific IgG antibodies changed from negative to positive “The recovery period is 4 times higher than that of the acute period.”
Is an antibody (“tocilizumab”) to the IL-6 Receptor (IL-6R) included in this guidance?
Yes. As the translation states: “For severe and critically ill patients with cytokine storms, in order to remove inflammatory factors, block “cytokine storms” and increase “blood purification treatment”. Add “tocilizumab” for immunotherapy: the indication is “those with extensive lung disease and severe patients, and those with elevated IL-6 levels detected by the laboratory”. The specific usage and dosage are given. Pay attention to allergic reactions, and those with active infection such as tuberculosis are prohibited”.
Where can one find the Chinese Clinical Trial Registry (China CTR) protocol for the still ongoing study of the Anti-IL-6 Receptor antibody “tocilizumab” for Covid-19?
Here is the link for the study titled: “A multicenter, randomized controlled trial for the efficacy and safety of tocilizumab in the treatment of novel coronavirus pneumonia (COVID-19)” is: http://www.chictr.org.cn/showproj.aspx?proj=49409. Q:
What information is listed regarding this Clinical Trial?
Detailed inclusion and exclusion criteria are listed. For example, a few of the inclusion criteria include ages 18-85 years, and elevated IL-6 levels by ELISA. A few of the exclusion criteria include ALT/AST > 5x ULN, active TB, or certain fungal infections. The primary outcome is “cure rate”. Secondary outcomes include mortality, ventilator utilization, and days of hospitalization. The comparison groups are: (A): “Conventional therapy” versus (B) “Conventional therapy plus tocilizumab”.
Does antibody to IL-6R prevent infection with the virus itself, or instead is it a potential treatment for “cytokine storm”, including the inflammatory cytokine IL-6, seen in some patients with COVID-19?
The antibody against the Receptor for IL-6 does not prevent infection with the virus. Instead, it is a potential treatment for “cytokine storm” or “cytokine release syndrome” in some patients with COVID19.
Where can one find the the official US Food and Drug Administration information on clinical indications, dosing, adverse events, and other information for tocilizumab?
Here is the US FDA label for tocilizumab Note that the 5th of 5 FDA clinical indications is: “Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome.”
Daniel Lucey, M.D. MPH, FIDSA, FACP, is an infectious diseases physician and adjunct professor of infectious diseases at Georgetown University Medical Center, a senior scholar at the Georgetown University O’Neil Institute, Anthropology Research Associate, Smithsonian Museum of Natural History and a member of the Infectious Diseases Society of America Global Health Committee.He has served as a volunteer medical responder to outbreaks that included the West Africa Ebola crisis. He has collected information on outbreaks starting in 2001 with cases of anthrax in 2001, and including smallpox vaccination 2002, SARS 2003, H5N1 Flu 2004, MERS in 2013, and Ebola in April, 2014, He has gathered, and updated information on the spread of the coronavirus Jan. 6.