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1.
EuropePMC; 2020.
Preprint in English | EuropePMC | ID: ppcovidwho-325137

ABSTRACT

Background: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive impact on human health. Due to the absence of antiviral medicine for COVID-19 thus far, it is desperately need to develop the effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, hoping to produce clinical efficacy and decrease the use of antibiotics and glucocorticoid. The aim of this study is to evaluate the efficacy and safety of Baidu Jieduan granule in curing COVID-19. Methods: /design: This multicenter, open-label randomized controlled trial is conducted 300 cases with COVID-19. The patients will be randomly (1:1) divided into treatment group or control group. All cases will receive standard therapy at the same time. The experiment group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes are assessed at baseline and at 3, 5, 7, 14 days after treatment initiation. The primary outcome is the rate of symptom (fever, fatigue, and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial. Discussion: The study will provide a high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granule in treatment of moderate COVID-19, and also enrich the theory and practice of TCM in treating COVID-19. Trial registration : Chinese Clinical Trial Registry, ChiCTR2000029869. Registered on 15 February 2020

2.
Medicine (Baltimore) ; 100(40): e27410, 2021 Oct 08.
Article in English | MEDLINE | ID: covidwho-1462560

ABSTRACT

ABSTRACT: The results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid as one of the criteria has been widely applied to assess whether the coronavirus disease 2019 (COVID-19) patients could discharge, however, the risk factors that affect the duration of the SARS-CoV-2 clearance remained to be an enigma. Our research was to identify risk factors correlated with prolonged duration of the SARS-CoV-2 clearance in moderate COVID-19 patients.We retrospectively analyzed 279 consecutive ordinary COVID-19 patients in 3 hospitals in Hubei province including Huangshi Hospital of Infectious Disease, Wuhan Thunder God Mountain Hospital, and Tongji Hospital. Eight clinical characters were contained as risk factors. We used a logistic regression model and nomogram to assess the possibility that the SARS-CoV-2 nucleic acid may turn negative in 14 days.Time from symptoms onset to diagnosis (odds ratio [OR] = 3.18; 95% confidence interval [CI] 1.56-6.46; P = .001), time from onset use of antiviral drugs to onset of symptoms (OR = 0.41; 95% CI 0.23-0.72; P = .02), and bacterial coinfection (OR = 0.07; 95% CI 0.01-0.86; P = .038) were independent risks factors for the duration of SARS-CoV-2 nucleic acid clearance. The regression model showed good accuracy and sensitivity (area under the curve  = 0.96). Nomogram was also provided to predict the negative conversion rate of SARS-CoV-2 nucleic acids within 14 days.Time from symptoms onset to diagnosi, time from onset use of antiviral drugs to onset of symptoms, and bacterial coinfection were independent risk factors for the time of SARS-CoV-2 nucleic acid turning negative in ordinary COVID-19 patients. However, the age, gender, underlying disease, fungal coinfection, and duration use of antiviral drugs were irrelevant factors.


Subject(s)
COVID-19/physiopathology , Nucleic Acids/metabolism , SARS-CoV-2/metabolism , Adolescent , Adult , Age Factors , Aged , Antiviral Agents/therapeutic use , COVID-19/drug therapy , China , Coinfection , Female , Humans , Logistic Models , Male , Middle Aged , Retrospective Studies , Risk Factors , Severity of Illness Index , Sex Factors , Time-to-Treatment , Young Adult
3.
Trials ; 22(1): 476, 2021 Jul 22.
Article in English | MEDLINE | ID: covidwho-1322945

ABSTRACT

BACKGROUND: Currently, coronavirus disease-2019 (COVID-19) is continuously and rapidly circulating, resulting in serious and extensive effects on human health. Due to the absence of antiviral medicine for COVID-19 thus far, there is a desperate need to develop effective medicine. Traditional Chinese medicine (TCM) has been widely applied in the treatment of epidemic diseases in China, with the aim of achieving clinical efficacy and decreasing the use of antibiotics and glucocorticoids. The aim of this study was to evaluate the efficacy and safety of Baidu Jieduan granules in treating COVID-19. METHODS/DESIGN: This multicentre, open-label, randomized controlled trial will be conducted in 300 patients with COVID-19. The patients will be randomly (1:1) divided into a treatment group and a control group. All patients will receive standard therapy at the same time. Patients in the experimental group will receive Baidu Jieduan granule treatment twice a day for 14 days. The outcomes will be assessed at baseline and at 3, 5, 7 and 14 days after treatment initiation. The primary outcome will be the rate of symptom (fever, fatigue and coughing) recovery. Adverse events (AEs) will be monitored throughout the trial. DISCUSSION: The study will provide high-quality clinical evidence to support the efficacy and safety of Baidu Jieduan granules in the treatment of moderate COVID-19, and enrich the theory and practice of TCM in treating COVID-19. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000029869 . Registered on 15 February 2020.


Subject(s)
COVID-19 , Medicine, Chinese Traditional , Antiviral Agents/therapeutic use , China , Humans , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , SARS-CoV-2 , Treatment Outcome
4.
Medicine (Baltimore) ; 99(51): e23874, 2020 Dec 18.
Article in English | MEDLINE | ID: covidwho-1087852

ABSTRACT

INTRODUCTION: The outbreak of novel coronavirus disease 2019 (COVID-19) has caused a global pandemic since December 2020. It has not only associated with physiological disorder but also with psychological distress and symptoms of mental illness. Whether the vaccines and antivirals can provide protects remains unknown. Traditional Chinese medicine (TCM) is recommended as an alternative and significant way of preventing and treating COVID-19 in China. However, few studies have assessed the benefits of this treatment and mental health after they recover. Our study is designed to investigate effects and safety when using TCM on the course of this disease and the impact of COVID-19 on pandemic-related anxiety. METHOD: For this prospective cohort study, we will enroll 300 COVID-19 patients aged 18 to 80 years at 4 centers. We divide them into 2 groups, according to whether they use Baidu Jieduan Granule at a ratio of 1:1. We will compare treatments combined Baidu Jieduan Granule with conventional Western medicine (experimental group) vs treatment of conventional Western medicine only (control group). The basic information of patients including demographic, general condition, primary diseases, and complications will be assessed. Related examines will be conducted at 1, 3, 5, 7, and 14 days. The primary outcomes are clinical outcome. A follow-up time of 1 year (to June 30, 2021) allow us to evaluate the psychiatric disorder after recovery. We will monitor adverse events throughout the trial. DISCUSSION: It will be the first prospective cohort study which uses Baidu Jieduan Granule, based on the innovation traditional Chinese medicine strategy of " Internal and External Relieving -Truncated Torsion " to treat the common type of COVID-19. The result of this study may provide evidence-based recommendations of TCM for treatment and psychological distress or symptoms of mental illness of the common type of COVID-19.


Subject(s)
COVID-19/drug therapy , Drugs, Chinese Herbal/therapeutic use , Humans
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