scholarly journals Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebo-controlled clinical trial

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001455 ◽  
Author(s):  
Maria Isabel Lopes ◽  
Leticia P Bonjorno ◽  
Marcela C Giannini ◽  
Natalia B Amaral ◽  
Pamella Indira Menezes ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Standard Treatment ◽  
Supplemental Oxygen ◽  
Controlled Clinical Trial ◽  
Beneficial Effects ◽  
Primary Endpoints ◽  
Registration Number ◽  
Double Blinded ◽  
Supplemental Oxygen Therapy

ObjectiveTo evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes.DesignWe present the results of a randomised, double-blinded, placebo-controlled clinical trial of colchicine for the treatment of moderate to severe COVID-19, with 75 patients allocated 1:1 from 11 April to 30 August 2020. Colchicine regimen was 0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The primary endpoints were the need for supplemental oxygen, time of hospitalisation, need for admission and length of stay in intensive care unit and death rate.ResultsSeventy-two patients (36 for placebo and 36 for colchicine) completed the study. Median (and IQR) time of need for supplemental oxygen was 4.0 (2.0–6.0) days for the colchicine group and 6.5 (4.0–9.0) days for the placebo group (p<0.001). Median (IQR) time of hospitalisation was 7.0 (5.0–9.0) days for the colchicine group and 9.0 (7.0–12.0) days for the placebo group (p=0.003). At day 2, 67% versus 86% of patients maintained the need for supplemental oxygen, while at day 7, the values were 9% versus 42%, in the colchicine and the placebo groups, respectively (log rank; p=0.001). Two patients died, both in placebo group. Diarrhoea was more frequent in the colchicine group (p=0.26).ConclusionColchicine reduced the length of both, supplemental oxygen therapy and hospitalisation. The drug was safe and well tolerated. Once death was an uncommon event, it is not possible to ensure that colchicine reduced mortality of COVID-19.Trial registration numberRBR-8jyhxh.

scholarly journals Beneficial effects of colchicine for moderate to severe COVID-19: an interim analysis of a randomized, double-blinded, placebo controlled clinical trial

2020 ◽  
Author(s):  
Maria Isabel F Lopes ◽  
Leticia P Bonjorno ◽  
Marcela C Giannini ◽  
Natalia B Amaral ◽  
Maira N Benatti ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Adverse Events ◽  
Interim Analysis ◽  
Supplemental Oxygen ◽  
Serum Lactate Dehydrogenase ◽  
Controlled Clinical Trial ◽  
C Reactive Protein ◽  
Reactive Protein ◽  
Double Blinded

Introduction. Neutrophilia and high levels of proinflammatory cytokines and other mediators of inflammation are common finds in patients with severe acute respiratory syndrome due to COVID-19, a dramatic condition for which there is no specific treatment, but supportive care and attempts to control the systemic inflammation. By its action on leukocytes, we propose colchicine as an intervention worthy of being tested. Objective. To evaluate whether the addition of colchicine to standard treatment for COVID-19 results in better outcomes. Methods. We present the interim analysis of a single-center randomized, double-blinded, placebo controlled clinical trial of colchicine for the treatment of moderate to severe COVID-19, with 38 patients allocated 1:1 from April 11 to July 06, 2020. Colchicine regimen was 0.5 mg thrice daily for 5 days, then 0.5 mg twice daily for 5 days. The first dose was 1.0 mg whether body weight was ≥ 80 kg. Endpoints. The primary endpoints were the need for supplemental oxygen; time of hospitalization; need for admission and length of stay in intensive care unit; and death rate and causes of mortality. As secondary endpoints, we assessed: serum C-reactive protein, serum Lactate dehydrogenase and relation neutrophil to lymphocyte of peripheral blood samples from day zero to day 7; the number, type, and severity of adverse events; frequency of interruption of the study protocol due to adverse events; and frequency of QT interval above 450 ms. Results. Thirty-five patients (18 for Placebo and 17 for Colchicine) completed the study. Both groups were comparable in terms of demographic, clinical and laboratory data at baseline. Median (and interquartile range) time of need for supplemental oxygen was 3.0 (1.5-6.5) days for the Colchicine group and 7.0 (3.0-8.5) days for Placebo group (p = 0.02). Median (IQR) time of hospitalization was 6.0 (4.0-8.5) days for the Colchicine group and 8.5 (5.5-11.0) days for Placebo group (p = 0.03). At day 2, 53% vs 83% of patients maintained the need for supplemental oxygen, while at day 7 the values were 6% vs 39%, in the Colchicine and Placebo groups, respectively (log rank; p = 0.01). Hospitalization was maintained for 53% vs 78% of patients at day 5 and 6% vs 17% at day 10, for the Colchicine and Placebo groups, respectively (log rank; p = 0.01). One patient per group needed admission to ICU. No recruited patient died. At day 4, patients of Colchicine group presented significant reduction of serum C-reactive protein compared to baseline (p < 0.001). The majority of adverse events were mild and did not lead to patient withdrawal. Diarrhea was more frequent in the Colchicine group (p = 0.17). Cardiac adverse events were absent. Discussion. The use of colchicine reduced the length of both, supplemental oxygen therapy and hospitalization. Shortly less than half of the patients of the Colchicine group stopped receiving supplemental oxygen until day 2. Clinical improvement was in parallel with a reduction on serum levels of C-reactive protein. The drug was safe and well tolerated. Colchicine may be considered a beneficial and not expensive option for COVID-19 treatment. Clinical trials with larger numbers of patients should be conducted to further evaluate the efficacy and safety of colchicine as an adjunctive therapy for hospitalized patients with moderate to severe COVID-19.

scholarly journals Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. e1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Common Cold ◽  
Primary Outcome Measure ◽  
Drug Group ◽  
Controlled Clinical Trial ◽  
Significant Difference ◽  
Preventive Efficacy ◽  
Double Blinded ◽  
Self Administered Questionnaire

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]  

scholarly journals Effectiveness and safety of Chinese herbal medicine xuanbi antong granules for the treatment of borderline coronary lesions: study protocol for a randomised, double-blinded, placebo-controlled, multicentre clinical trial

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e024968 ◽  
Author(s):  
Mingyan Huang ◽  
Guang Chen ◽  
Qingya Guan ◽  
Chao Liu ◽  
Qing Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Clinical Symptoms ◽  
Early Stage ◽  
Intervention Group ◽  
Blood Lipid ◽  
Controlled Clinical Trial ◽  
Cardiac Events ◽  
Coronary Syndrome ◽  
Double Blinded

IntroductionAs the early stage of coronary heart disease (CHD), borderline coronary lesion (BCL) is defined as a 30%–70% diameter stenosis. Previous studies have demonstrated that BCL may progress to acute coronary syndrome easily. However, routine medications available for the treatments of BCL have some limitations. Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years. Previous studies have shown that XAG has effectiveness in improving clinical symptoms and quality of life in patients with CHD. This study aims to evaluate the effectiveness and safety of XAG in patients with BCL.Methods and analysisThis is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 300 participants will be randomly assigned to the intervention group and the placebo group. Based on routine medications, the intervention group will be treated with XAG and the placebo group will be treated with XAG placebo. All participants will receive a 6-month treatment and then be followed-up for another 6 months. The primary outcomes are the changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score) measured by dual source CT angiography. The secondary outcomes include blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events. All the data will be recorded in electronic case report forms and analysed by SPSS V.20.0.Ethics and disseminationThis study has been approved by Research Ethics Committee of Guang’anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2017–083-KY-01). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registration numberChiCTR-IOR-17013189; Pre-results.

scholarly journals Efficacy of intravenous infusions of UC-derived MSCs for the treatment of COVID-19: A structured summary of a phase II double blinded, randomized controlled clinical trial

2020 ◽  
Author(s):  
Muhammad Ali ◽  
Azra Mehmood ◽  
Moazzam Nazeer Tarar ◽  
John D Gottsch ◽  
Zafar Nawaz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Responses ◽  
Standard Of Care ◽  
Convincing Evidence ◽  
Controlled Clinical Trial ◽  
Immune Reactivity ◽  
Randomized Controlled Clinical Trial ◽  
Beneficial Effects ◽  
Randomized Controlled ◽  
Double Blinded

Abstract In this clinical research project, we will conduct a highly rigorous clinical trial where we randomize the patients between umbilical cord (UC)-derived mesenchymal stem cell (MSC) and standard of care (SOC). This study will ask the question whether the allogenic MSCs are effective in reducing death and/or progression of COVID-19 disease when administered to patients with moderate to severe symptoms. MSCs are unique group of cells with minimal immune reactivity and produce multiple beneficial effects, which include reduction of severe inflammatory reaction. There is convincing evidence from human studies that intravenous (IV) delivery of MSCs can directly impact the hyper-inflammatory responses of COVID-19 induced injury of the heart and lungs. Our study will evaluate the safety and efficacy of allogenic UC-derived MSCs administered intravenously to COVID-19 patients with moderate to severe symptom in a randomized, controlled clinical trial. In addition, we will determine whether : (i) UC-derived MSCs are effective in reducing 30-day all-cause mortality (primary endpoint) and (ii) UC-derived MSCs are effective in preventing progression to mechanical ventilation, and/or reducing an inflammatory response, and/or improving overall patient condition (secondary endpoints).

scholarly journals Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

2020 ◽  
Vol 9 ◽  
pp. 1462
Author(s):  
Mehdi Pasalar ◽  
Seyed Hamdollah Mosavat ◽  
Hossein Molavi Vardanjani ◽  
Mohsen Keshavarz ◽  
Maryam Mosaffa-Jahromi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Common Cold ◽  
Primary Outcome Measure ◽  
Drug Group ◽  
Controlled Clinical Trial ◽  
Significant Difference ◽  
Preventive Efficacy ◽  
Double Blinded ◽  
Self Administered Questionnaire

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]

scholarly journals Efficacy of intravenous infusions of UC-derived MSCs for the treatment of COVID-19: A structured summary of a phase II double blinded, randomized controlled clinical trial

2020 ◽  
Author(s):  
Muhammad Ali ◽  
Azra Mehmood ◽  
Moazzam Nazeer Tarar ◽  
Zafar Nawaz ◽  
S. Amer Riazuddin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Responses ◽  
Standard Of Care ◽  
Convincing Evidence ◽  
Controlled Clinical Trial ◽  
Immune Reactivity ◽  
Randomized Controlled Clinical Trial ◽  
Beneficial Effects ◽  
Randomized Controlled ◽  
Double Blinded

Abstract In this clinical research project, we will conduct a highly rigorous clinical trial where we randomize the patients between umbilical cord (UC)-derived mesenchymal stem cell (MSC) and standard of care (SOC). This study will ask the question whether the allogenic MSCs are effective in reducing death and/or progression of COVID-19 disease when administered to patients with moderate to severe symptoms. MSCs are unique group of cells with minimal immune reactivity and produce multiple beneficial effects, which include reduction of severe inflammatory reaction. There is convincing evidence from human studies that intravenous (IV) delivery of MSCs can directly impact the hyper-inflammatory responses of COVID-19 induced injury of the heart and lungs. Our study will evaluate the safety and efficacy of allogenic UC-derived MSCs administered intravenously to COVID-19 patients with moderate to severe symptom in a randomized, controlled clinical trial. In addition, we will determine whether : (i) UC-derived MSCs are effective in reducing 30-day all-cause mortality (primary endpoint) and (ii) UC-derived MSCs are effective in preventing progression to mechanical ventilation, and/or reducing an inflammatory response, and/or improving overall patient condition (secondary endpoints).

Liraglutide as an Additional Treatment to Insulin in Patients with Type 1 Diabetes Mellitus—A 52-Week Randomized Double-Blinded Placebo-Controlled Clinical Trial

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 3-LB ◽  
Author(s):  
PARESH DANDONA ◽  
HUSAM GHANIM ◽  
NITESH D. KUHADIYA ◽  
TANVI SHAH ◽  
JEANNE M. HEJNA ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Clinical Trial ◽  
Type 1 Diabetes ◽  
Type 1 Diabetes Mellitus ◽  
Additional Treatment ◽  
Controlled Clinical Trial ◽  
Double Blinded

scholarly journals Administration of Apple Polyphenol Supplements for Skin Conditions in Healthy Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1071
Author(s):  
Toshihiko Shoji ◽  
Saeko Masumoto ◽  
Nina Moriichi ◽  
Yasuyuki Ohtake ◽  
Tomomasa Kanda
Keyword(s):  
Clinical Trial ◽  
Uv Irradiation ◽  
Skin Pigmentation ◽  
Controlled Clinical Trial ◽  
Continuous Administration ◽  
Double Blind ◽  
Healthy Women ◽  
Dependent Relationship ◽  
Skin Conditions ◽  
Double Blinded

This clinical study was performed to evaluate the effects of continuous apple polyphenol (AP) administration on facial skin conditions and pigmentation induced by ultraviolet (UV) irradiation in healthy women participants. Participants (n = 65, age 20–39 years) were randomized to receive tablets containing AP (300 or 600 mg/day) or placebo in a double-blinded, placebo-controlled clinical trial. Continuous administration of AP for 12 weeks significantly prevented UV irradiation induced skin pigmentation (erythema value, melanin value, L value), although a dose-dependent relationship was not clearly observed. In contrast, no significant differences were detected between the groups with regard to water content and trans-epidermal water loss. Our study demonstrated that APs and their major active compounds, procyanidins, have several health benefits. Here, we report that continuous administration of AP for 12 weeks alleviated UV irradiation induced skin pigmentation, when compared with placebo, in healthy women.

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