The efficient transmission of severe acute respiratory syndrome-2 coronavirus(SARS-CoV-2)from patients to health care workers or family members has been a worrisome and prominent feature of the ongoing outbreak.On the...The efficient transmission of severe acute respiratory syndrome-2 coronavirus(SARS-CoV-2)from patients to health care workers or family members has been a worrisome and prominent feature of the ongoing outbreak.On the basis of clinical practice and in-vitro studies,we postulated that post-exposure prophylaxis(PEP)using Arbidol is associated with decreased infection among individuals exposed to confirmed cases of COVID-19 infection.We conducted a retrospective cohort study on family members and health care workers who were exposed to patients confirmed to have SARS-CoV-2 infection by real-time RT-PCR and chest computed tomography(CT)from January 1 to January 16,2020.The last follow-up date was Feb.26,2020.The emergence of fever and/or respiratory symptoms after exposure to the primary case was collected.The correlations between post-exposure prophylaxis and infection in household contacts and health care workers were respectively analyzed.A total of 66 members in 27 families and 124 health care workers had evidence of close exposure to patients with confirmed COVID-19.The Cox regression based on the data of the family members and health care workers with Arbidol or not showed that Arbidol PEP was a protective factor against the development of COVID-19(HR 0.025,95%CI 0.003-0.209,P=0.0006 for family members and HR 0.056,95%CI 0.005-0.662,P=0.0221 for health care workers).Our findings suggest Arbidol could reduce the infection risk of the novel coronavirus in hospital and family settings.This treatment should be promoted for PEP use and should be the subject of further investigation.展开更多
To date,no treatment has proven to be absolutely effective for coronavirus disease 2019(COVID-19)patients,and further research is necessary.As a traditional antiviral drug,arbidol was widely used in Wuhan at the begin...To date,no treatment has proven to be absolutely effective for coronavirus disease 2019(COVID-19)patients,and further research is necessary.As a traditional antiviral drug,arbidol was widely used in Wuhan at the beginning of the COVID-19 epidemic and is of increasing interest for treating COVID-19 based on in vitro data suggesting activity against severe acute respiratory syndrome(SARS).Although arbidol has been widely used in China to treat COVID-19 patients,clinical trials to date have not clearly substantiated this approach.AIM To evaluate the efficacy of arbidol for COVID-19.METHODS A retrospective study was conducted on 132 moderate and severe COVID-19 patients admitted to Jinyintan Hospital and Huoshenshan Hospital(officially designated for COVID-19 treatment)from February to March 2020 in Wuhan,China.This study mainly evaluated the efficacy of arbidol in patients with COVID-19 in the early stage of the SARS coronavirus 2 epidemic.Arbidol was administered at a dose of 200 mg,three times a day,with a 10-d course to adults not receiving any other drugs.Due to the shortage of beds at the time,not every patient could be admitted immediately.We looked for the early stages of the sudden outbreak,places of limited medical resources,limited ward beds,and delayed admission;thus,some patients naturally fit into the control group who did not receive any antiviral drugs.Out of the 132 patients,72 received arbidol treatment,and 60 did not.We compared the disease course of the two groups and explored the predictors of extended disease duration.RESULTS Seventy-two patients commenced arbidol,and 60 patients did not receive arbidol treatment.The disease duration in the former group was shorter(23.42±6.92 vs 29.60±6.49,P<0.001).Multivariate regression analysis showed that the risk of a prolonged course of disease increased by 7.158 times in the non-arbidol treatment group.Ferritin>483.0 ng/mL and lactate dehydrogenase(LDH)>237.5 U/L were found to be independent risk factors for protracted cases,with the risk of an extended disease duration increasing to 2.852 times and 5.946 times,respectively.CONCLUSION The duration course of moderate and severe COVID-19 patients is reduced by 6.183 d when arbidol is administered.Ferritin>486.5 ng/mL and LDH>239.5 U/L are independent risk factors for delayed recovery from COVID-19.Early oral administration of arbidol 200 mg t.i.d.with a 10-d course of treatment may be an effective management strategy in COVID-19 patients,particularly those with increased serum ferritin or elevated LDH.展开更多
The purpose of this study was to cover the bitter taste of arbidol hydrochloride(ARB)and develop dry suspension with combination of solid dispersion and flavors.Taste masking was successfully done by solid dispersion ...The purpose of this study was to cover the bitter taste of arbidol hydrochloride(ARB)and develop dry suspension with combination of solid dispersion and flavors.Taste masking was successfully done by solid dispersion using octadecanol as the carrier by fusion method.Suspending agents,carriers and other excipients were selected.Differential scanning calorimetry(DSC)and Fourier transform infrared spectroscopy(FTIR)were performed to identify the physicochemical interaction between drug and carrier,DSC analysis indicated that ARB was amorphous in the solid dispersion,FTIR spectroscopy showed no interaction between drug and carrier.Taste masking was evaluated on six volunteers with a score of 4.9.The results demonstrated successful taste masking.Water was used to study the in vitro dissolution performance of the three formulations of commercial tablet,capsule and self-made suspension.The self-made suspension showed a lower and slower release,the insoluble carrier octadecanol blocked the drug dissolving from the solid dispersion.It was indicated from the primary stability study,the self-made suspensions were sensitive to high temperature,high humidity and strong light conditions,they should be stored in sealed containers away from heat,light and humidity.展开更多
Objective:To study data about SARS-CoV-2 virus shedding and clarify the risk factors for prolonged virus shedding.Methods:Data were retrospectively collected from adults hospitalized with laboratory-confirmed coronavi...Objective:To study data about SARS-CoV-2 virus shedding and clarify the risk factors for prolonged virus shedding.Methods:Data were retrospectively collected from adults hospitalized with laboratory-confirmed coronavirus disease-19(COVID-19)in Wuhan Union Hospital.We compared clinical features among patients with prolonged(a positive SARS-CoV-2 RNA on day 23 after illness onset)and short virus shedding and evaluated risk factors associated with prolonged virus shedding by multivariate regression analysis.Results:Among 238 patients,the median age was 55.5 years,57.1%were female,92.9%(221/238)were administered with arbidol,58.4%(139/238)were given arbidol in combination with interferon.The median duration of SARS-CoV-2 virus shedding was 23 days(IQR,17.8-30 days)with a longest one of 51 days.The patients with prolonged virus shedding had higher value of D-dimer(P=0.002),IL-6(P<0.001),CRP(P=0.005)and more lobes lung lesion(P=0.014)on admission,as well as older age(P=0.017)and more patients with hypertension(P=0.044)than in those the virus shedding less than 23 days.Multivariate regression analysis revealed that prolonged viral shedding was significantly associated with initiation arbidol≥8 days after symptom onset[OR:2.447,95%CI(1.351-4.431)],≥3 days from onset of symptoms to first medical visitation[OR:1.880,95%CI(1.035-3.416)],illness onset before Jan.31,2020[OR:3.289,95%CI(1.474-7.337)].Arbidol in combination with interferon was also significantly associated with shorter virus shedding[OR:0.363,95%CI(0.191-0.690)].Conclusion:Duration of SARS-CoV-2 virus shedding was long.Early initiation of arbidol and arbidol in combination with interferon as well as consulting doctor timely after illness onset were helpful for SARS-CoV-2 clearance.展开更多
Background:From early experience,some Traditional Chinese Medicine and Arbidol had effects of against COVID-19,infer that the combination of Liushen capsules and Arbidol may further increase the therapeutic.Methods/De...Background:From early experience,some Traditional Chinese Medicine and Arbidol had effects of against COVID-19,infer that the combination of Liushen capsules and Arbidol may further increase the therapeutic.Methods/Design:We conducted a randomized,blank parallel-controlled,open-label,multi-center,basal therapy-loaded design clinical trial.A total of 40 patients are going to be recruited after satisfying the criteria.Participants will be allocated randomly into the treatment group with the combination of Arbidol and Liushen capsules and the control group with the basic therapy.Each group will receive treatment at least 7-days or until the virus becomes negative,and visits after drug administration at day 3(visit 1),the day when the virus becomes negative(visit 2),day 7(visit 3),the day before discharge(visit 4)and day 28(visit 5),to collect their survival status and disease prognosis so that the efficacy and safety of a combination of Arbidol and Liushen capsule will be evaluated.Discussion:We described the protocol of the first clinical trial for treatment COVID-19 by using a combination of Arbidol and Liushen capsules.The results of this study will provide a basis for the design and sample size estimate of subsequent large-scale clinical trials.Trial registration:This study has been registered at Chinese clinical trial Registry(chictr.org.cn):ChiCTR2000029993.展开更多
Background: To date, there is no effective medicine to treat coronavirus disease 2019 (COVID-19), and the antiviral efficacy of arbidol in the treatment for COVID-19 remained equivocal and controversial. The purpose o...Background: To date, there is no effective medicine to treat coronavirus disease 2019 (COVID-19), and the antiviral efficacy of arbidol in the treatment for COVID-19 remained equivocal and controversial. The purpose of this study was to evaluate the efficacy and safety of arbidol tablets in the treatment of COVID-19.Methods: This was a prospective, open-label, controlled and multicenter investigator-initiated trial involving adult patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Patients were stratified 1:2 to either standard-of-care (SOC) or SOC plus arbidol tablets (oral administration of 200 mg per time, three times a day for 14 days). The primary endpoint was negative conversion of SARS-CoV-2 within the first week. The rates and 95% confidential intervals were calculated for each variable.Results: A total of 99 patients with laboratory-confirmed SARS-CoV-2 infection were enrolled;66 were assigned to the SOC plus arbidol tablets group, and 33 to the SOC group. The negative conversion rate of SARS-CoV-2 within the first week in patients receiving arbidol tablets was significantly higher than that of the SOC group (70.3% [45/64]vs. 42.4% [14/33];difference of conversion rate 27.9%;95% confidence interval [CI], 7.7%-48.1%;P=0.008). Compared to those in the SOC group, patients receiving arbidol tablets had a shorter duration of clinical recovery (median 7.0 daysvs. 12.0 days;hazard ratio [HR]: 1.877, 95% CI: 1.151-3.060,P=0.006), symptom of fever (median 3.0 daysvs. 12.0 days;HR: 18.990, 95% CI: 5.350-67.410,P<0.001), as well as hospitalization (median 12.5 daysvs. 20.0 days;P<0.001). Moreover, the addition of arbidol tablets to SOC led to more rapid normalization of declined blood lymphocytes (median 10.0 daysvs. 14.5 days;P > 0.05). The most common adverse event in the arbidol tablets group was the elevation of transaminase (5/200, 2.5%), and no one withdrew from the study due to adverse events or disease progression.Conclusions: SOC plus arbidol tablets significantly increase the negative conversion rate of SARS-CoV-2 within the first week and accelerate the recovery of COVID-19 patients. During the treatment with arbidol tablets, we find no significant serious adverse events.展开更多
文摘The efficient transmission of severe acute respiratory syndrome-2 coronavirus(SARS-CoV-2)from patients to health care workers or family members has been a worrisome and prominent feature of the ongoing outbreak.On the basis of clinical practice and in-vitro studies,we postulated that post-exposure prophylaxis(PEP)using Arbidol is associated with decreased infection among individuals exposed to confirmed cases of COVID-19 infection.We conducted a retrospective cohort study on family members and health care workers who were exposed to patients confirmed to have SARS-CoV-2 infection by real-time RT-PCR and chest computed tomography(CT)from January 1 to January 16,2020.The last follow-up date was Feb.26,2020.The emergence of fever and/or respiratory symptoms after exposure to the primary case was collected.The correlations between post-exposure prophylaxis and infection in household contacts and health care workers were respectively analyzed.A total of 66 members in 27 families and 124 health care workers had evidence of close exposure to patients with confirmed COVID-19.The Cox regression based on the data of the family members and health care workers with Arbidol or not showed that Arbidol PEP was a protective factor against the development of COVID-19(HR 0.025,95%CI 0.003-0.209,P=0.0006 for family members and HR 0.056,95%CI 0.005-0.662,P=0.0221 for health care workers).Our findings suggest Arbidol could reduce the infection risk of the novel coronavirus in hospital and family settings.This treatment should be promoted for PEP use and should be the subject of further investigation.
文摘To date,no treatment has proven to be absolutely effective for coronavirus disease 2019(COVID-19)patients,and further research is necessary.As a traditional antiviral drug,arbidol was widely used in Wuhan at the beginning of the COVID-19 epidemic and is of increasing interest for treating COVID-19 based on in vitro data suggesting activity against severe acute respiratory syndrome(SARS).Although arbidol has been widely used in China to treat COVID-19 patients,clinical trials to date have not clearly substantiated this approach.AIM To evaluate the efficacy of arbidol for COVID-19.METHODS A retrospective study was conducted on 132 moderate and severe COVID-19 patients admitted to Jinyintan Hospital and Huoshenshan Hospital(officially designated for COVID-19 treatment)from February to March 2020 in Wuhan,China.This study mainly evaluated the efficacy of arbidol in patients with COVID-19 in the early stage of the SARS coronavirus 2 epidemic.Arbidol was administered at a dose of 200 mg,three times a day,with a 10-d course to adults not receiving any other drugs.Due to the shortage of beds at the time,not every patient could be admitted immediately.We looked for the early stages of the sudden outbreak,places of limited medical resources,limited ward beds,and delayed admission;thus,some patients naturally fit into the control group who did not receive any antiviral drugs.Out of the 132 patients,72 received arbidol treatment,and 60 did not.We compared the disease course of the two groups and explored the predictors of extended disease duration.RESULTS Seventy-two patients commenced arbidol,and 60 patients did not receive arbidol treatment.The disease duration in the former group was shorter(23.42±6.92 vs 29.60±6.49,P<0.001).Multivariate regression analysis showed that the risk of a prolonged course of disease increased by 7.158 times in the non-arbidol treatment group.Ferritin>483.0 ng/mL and lactate dehydrogenase(LDH)>237.5 U/L were found to be independent risk factors for protracted cases,with the risk of an extended disease duration increasing to 2.852 times and 5.946 times,respectively.CONCLUSION The duration course of moderate and severe COVID-19 patients is reduced by 6.183 d when arbidol is administered.Ferritin>486.5 ng/mL and LDH>239.5 U/L are independent risk factors for delayed recovery from COVID-19.Early oral administration of arbidol 200 mg t.i.d.with a 10-d course of treatment may be an effective management strategy in COVID-19 patients,particularly those with increased serum ferritin or elevated LDH.
文摘The purpose of this study was to cover the bitter taste of arbidol hydrochloride(ARB)and develop dry suspension with combination of solid dispersion and flavors.Taste masking was successfully done by solid dispersion using octadecanol as the carrier by fusion method.Suspending agents,carriers and other excipients were selected.Differential scanning calorimetry(DSC)and Fourier transform infrared spectroscopy(FTIR)were performed to identify the physicochemical interaction between drug and carrier,DSC analysis indicated that ARB was amorphous in the solid dispersion,FTIR spectroscopy showed no interaction between drug and carrier.Taste masking was evaluated on six volunteers with a score of 4.9.The results demonstrated successful taste masking.Water was used to study the in vitro dissolution performance of the three formulations of commercial tablet,capsule and self-made suspension.The self-made suspension showed a lower and slower release,the insoluble carrier octadecanol blocked the drug dissolving from the solid dispersion.It was indicated from the primary stability study,the self-made suspensions were sensitive to high temperature,high humidity and strong light conditions,they should be stored in sealed containers away from heat,light and humidity.
基金supported by Fundamental Research Funds for the Central Universities(No.2020kfyXGYJ034,No.2020kfyXGYJ009).
文摘Objective:To study data about SARS-CoV-2 virus shedding and clarify the risk factors for prolonged virus shedding.Methods:Data were retrospectively collected from adults hospitalized with laboratory-confirmed coronavirus disease-19(COVID-19)in Wuhan Union Hospital.We compared clinical features among patients with prolonged(a positive SARS-CoV-2 RNA on day 23 after illness onset)and short virus shedding and evaluated risk factors associated with prolonged virus shedding by multivariate regression analysis.Results:Among 238 patients,the median age was 55.5 years,57.1%were female,92.9%(221/238)were administered with arbidol,58.4%(139/238)were given arbidol in combination with interferon.The median duration of SARS-CoV-2 virus shedding was 23 days(IQR,17.8-30 days)with a longest one of 51 days.The patients with prolonged virus shedding had higher value of D-dimer(P=0.002),IL-6(P<0.001),CRP(P=0.005)and more lobes lung lesion(P=0.014)on admission,as well as older age(P=0.017)and more patients with hypertension(P=0.044)than in those the virus shedding less than 23 days.Multivariate regression analysis revealed that prolonged viral shedding was significantly associated with initiation arbidol≥8 days after symptom onset[OR:2.447,95%CI(1.351-4.431)],≥3 days from onset of symptoms to first medical visitation[OR:1.880,95%CI(1.035-3.416)],illness onset before Jan.31,2020[OR:3.289,95%CI(1.474-7.337)].Arbidol in combination with interferon was also significantly associated with shorter virus shedding[OR:0.363,95%CI(0.191-0.690)].Conclusion:Duration of SARS-CoV-2 virus shedding was long.Early initiation of arbidol and arbidol in combination with interferon as well as consulting doctor timely after illness onset were helpful for SARS-CoV-2 clearance.
基金This work was supported by the Science research project of the Guangdong Province[Grant No.2020B111110001]Guangzhou Medical University High-level University Clinical Research and Cultivation Program(Guangzhou Medical University released[2017]No.159,160).
文摘Background:From early experience,some Traditional Chinese Medicine and Arbidol had effects of against COVID-19,infer that the combination of Liushen capsules and Arbidol may further increase the therapeutic.Methods/Design:We conducted a randomized,blank parallel-controlled,open-label,multi-center,basal therapy-loaded design clinical trial.A total of 40 patients are going to be recruited after satisfying the criteria.Participants will be allocated randomly into the treatment group with the combination of Arbidol and Liushen capsules and the control group with the basic therapy.Each group will receive treatment at least 7-days or until the virus becomes negative,and visits after drug administration at day 3(visit 1),the day when the virus becomes negative(visit 2),day 7(visit 3),the day before discharge(visit 4)and day 28(visit 5),to collect their survival status and disease prognosis so that the efficacy and safety of a combination of Arbidol and Liushen capsule will be evaluated.Discussion:We described the protocol of the first clinical trial for treatment COVID-19 by using a combination of Arbidol and Liushen capsules.The results of this study will provide a basis for the design and sample size estimate of subsequent large-scale clinical trials.Trial registration:This study has been registered at Chinese clinical trial Registry(chictr.org.cn):ChiCTR2000029993.
基金Shanghai Top-Priority Clinical Key Disciplines Construction Project(No.2017ZZ02014)Shanghai Key Laboratory of Emergency Prevention,Diagnosis and Treatment of Respiratory Infectious Diseases(No.20dz2261100)Cultivation Project of Shanghai Major Infectious Disease Research Base(No.20dz2210500)。
文摘Background: To date, there is no effective medicine to treat coronavirus disease 2019 (COVID-19), and the antiviral efficacy of arbidol in the treatment for COVID-19 remained equivocal and controversial. The purpose of this study was to evaluate the efficacy and safety of arbidol tablets in the treatment of COVID-19.Methods: This was a prospective, open-label, controlled and multicenter investigator-initiated trial involving adult patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Patients were stratified 1:2 to either standard-of-care (SOC) or SOC plus arbidol tablets (oral administration of 200 mg per time, three times a day for 14 days). The primary endpoint was negative conversion of SARS-CoV-2 within the first week. The rates and 95% confidential intervals were calculated for each variable.Results: A total of 99 patients with laboratory-confirmed SARS-CoV-2 infection were enrolled;66 were assigned to the SOC plus arbidol tablets group, and 33 to the SOC group. The negative conversion rate of SARS-CoV-2 within the first week in patients receiving arbidol tablets was significantly higher than that of the SOC group (70.3% [45/64]vs. 42.4% [14/33];difference of conversion rate 27.9%;95% confidence interval [CI], 7.7%-48.1%;P=0.008). Compared to those in the SOC group, patients receiving arbidol tablets had a shorter duration of clinical recovery (median 7.0 daysvs. 12.0 days;hazard ratio [HR]: 1.877, 95% CI: 1.151-3.060,P=0.006), symptom of fever (median 3.0 daysvs. 12.0 days;HR: 18.990, 95% CI: 5.350-67.410,P<0.001), as well as hospitalization (median 12.5 daysvs. 20.0 days;P<0.001). Moreover, the addition of arbidol tablets to SOC led to more rapid normalization of declined blood lymphocytes (median 10.0 daysvs. 14.5 days;P > 0.05). The most common adverse event in the arbidol tablets group was the elevation of transaminase (5/200, 2.5%), and no one withdrew from the study due to adverse events or disease progression.Conclusions: SOC plus arbidol tablets significantly increase the negative conversion rate of SARS-CoV-2 within the first week and accelerate the recovery of COVID-19 patients. During the treatment with arbidol tablets, we find no significant serious adverse events.
