blueash
04-17-2020, 12:46 PM
This may be important (https://www.medrxiv.org/content/10.1101/2020.04.11.20061473v1.full.pdf), but it is not yet peer reviewed nor published. It is so good it is hard to believe and I'm try hard to find weaknesses. As has been said, extraordinary claims demand extraordinary proof.
From Hubei China.. which is the province with Wuhan but this hospital was not in Wuhan city. At a single hospital the authors enrolled 2944 doctors and nurses. They classified 529 as high risk as they worked in wards for isolation and fever. The other 2415 were a lower risk arm as they worked in regular wards. The study began on Jan 25 and ran 28 days. This timing is when the number of COVID cases had increased rapidly in Hubei, so lots of potential exposure of the participants.
Both groups were given recombinant human interferon alpha1b (rhIFN-α) nasal drops to be self administered 4 times a day for 28 days. The high risk arm was given a once a week shot of an additional medication but there was no other difference between arms.
The usual infection control protocols were unchanged, hand washing, PPE etc. All participants were followed for onset on COVID or symptoms suggestive of COVID. If fever or respiratory symptoms began the person had COVID testing. The comparison group was "number of new cases in medical staff in the same areas of Hubei Province during the same period"
There were ZERO new cases in either group. The control group of cases reported from other facilities in the same province is reported with this language:
"The control group was drawn from a literature report in the Chinese Journal of Epidemiology on medical staff diagnosed with COVID-19 pneumonia nationwide and in Wuhan from January 1 through February 11, 2020. Chinese medical staff diagnosed with COVID-19 pneumonia as reported by the China-World Health Organization joint inspection expert group as of February 23 were also included in the control group. The 422 medical institutions providing diagnosis and treatment services for patients with COVID-19 pneumonia reported that among 3387 medical personnel, there were 1716 confirmed cases, 1070 clinically diagnosed cases, and 157 suspected cases, and 3062 cases came from Hubei "
Later in the report the control group illness is reported differently
"Among the medical staff treated with this protocol, there were no COVID-19 cases reported over a 28-day observation period. In contrast, over the same period, more than 100 cases of COVID-19 were confirmed among medical staff at other hospitals in Hubei Province"
As there certainly is a delay in getting reports into any reporting system and then publishing the data, it is hard to know what was the ongoing real rate of new illness in the control group. Also we are not given a denominator of how many medical people worked in Hubei during the study period. But it is reasonable, but perhaps wrong, to think that there certainly were thousands of at risk personnel at other facilities. Either way, this is zero vs more than 100.
They did not test for antibodies to see if sub-clinical infection occurred. It would have been meaningless as those antibodies may not appear quickly giving false negatives, and if the participant had sub-clinical infection before the study, this would be a false positive. Importantly this illness has a potential long incubation period. I am concerned that as these personnel had exposure before the study, why didn't anyone become ill in its early phases. The claim is that the interferon prevents new infection, not that it stops already existing infection from being expressed. My cynical nature in reading studies has this failure to have a single person get sick make me wonder about the data as a whole. No side effects were reported.
This interferon was made by Beijing Tri-Prime Gene Pharmaceutical Co., Ltd., China, IFN-α 1b, 3000 µ/ml, in-hospital preparation. I do not know if any similar product is available here.
From Hubei China.. which is the province with Wuhan but this hospital was not in Wuhan city. At a single hospital the authors enrolled 2944 doctors and nurses. They classified 529 as high risk as they worked in wards for isolation and fever. The other 2415 were a lower risk arm as they worked in regular wards. The study began on Jan 25 and ran 28 days. This timing is when the number of COVID cases had increased rapidly in Hubei, so lots of potential exposure of the participants.
Both groups were given recombinant human interferon alpha1b (rhIFN-α) nasal drops to be self administered 4 times a day for 28 days. The high risk arm was given a once a week shot of an additional medication but there was no other difference between arms.
The usual infection control protocols were unchanged, hand washing, PPE etc. All participants were followed for onset on COVID or symptoms suggestive of COVID. If fever or respiratory symptoms began the person had COVID testing. The comparison group was "number of new cases in medical staff in the same areas of Hubei Province during the same period"
There were ZERO new cases in either group. The control group of cases reported from other facilities in the same province is reported with this language:
"The control group was drawn from a literature report in the Chinese Journal of Epidemiology on medical staff diagnosed with COVID-19 pneumonia nationwide and in Wuhan from January 1 through February 11, 2020. Chinese medical staff diagnosed with COVID-19 pneumonia as reported by the China-World Health Organization joint inspection expert group as of February 23 were also included in the control group. The 422 medical institutions providing diagnosis and treatment services for patients with COVID-19 pneumonia reported that among 3387 medical personnel, there were 1716 confirmed cases, 1070 clinically diagnosed cases, and 157 suspected cases, and 3062 cases came from Hubei "
Later in the report the control group illness is reported differently
"Among the medical staff treated with this protocol, there were no COVID-19 cases reported over a 28-day observation period. In contrast, over the same period, more than 100 cases of COVID-19 were confirmed among medical staff at other hospitals in Hubei Province"
As there certainly is a delay in getting reports into any reporting system and then publishing the data, it is hard to know what was the ongoing real rate of new illness in the control group. Also we are not given a denominator of how many medical people worked in Hubei during the study period. But it is reasonable, but perhaps wrong, to think that there certainly were thousands of at risk personnel at other facilities. Either way, this is zero vs more than 100.
They did not test for antibodies to see if sub-clinical infection occurred. It would have been meaningless as those antibodies may not appear quickly giving false negatives, and if the participant had sub-clinical infection before the study, this would be a false positive. Importantly this illness has a potential long incubation period. I am concerned that as these personnel had exposure before the study, why didn't anyone become ill in its early phases. The claim is that the interferon prevents new infection, not that it stops already existing infection from being expressed. My cynical nature in reading studies has this failure to have a single person get sick make me wonder about the data as a whole. No side effects were reported.
This interferon was made by Beijing Tri-Prime Gene Pharmaceutical Co., Ltd., China, IFN-α 1b, 3000 µ/ml, in-hospital preparation. I do not know if any similar product is available here.