Mo1126 – Rapid Recurrence of Symptoms, Endoscopic Findings, and Esophageal Eosinophilia Without Maintenance Thearpy After Successful Initial Treatment: Results from the Observation Phase of a Randomized, Double-Blind, Double Dummy Clinical Trial

Abstract Background: Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection.Methods: This study was conducted as a randomized placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)—four vials daily for three days (in addition to initial treatment), while the other group received a placebo. Patients’ demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded.Results: Among total study subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001–0.815]; P = 0.042).Conclusions: Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment.Trial registration: A study protocol was registered at the Iranian Registry of Clinical Trials (www.IRCT.ir), number IRCT20200501047259N1. It was registered retrospectively on May 17th, 2020.

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Muscle Uncoupling Protein 3 Expression Is Unchanged by Chronic Ephedrine/Caffeine Treatment: Results of a Double Blind, Randomised Clinical Trial in Morbidly Obese Females

PLoS ONE ◽

10.1371/journal.pone.0098244 ◽

2014 ◽

Vol 9 (6) ◽

pp. e98244 ◽

Cited By ~ 9

Author(s):

Renata Bracale ◽

Maria Letizia Petroni ◽

Sergio Davinelli ◽

Umberto Bracale ◽

Giovanni Scapagnini ◽

...

Keyword(s):

Clinical Trial ◽

Uncoupling Protein ◽

Randomised Clinical Trial ◽

Morbidly Obese ◽

Treatment Results ◽

Double Blind ◽

Caffeine Treatment ◽

Uncoupling Protein 3

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The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: a randomized placebo-controlled double-blind clinical trial

BMC Infectious Diseases ◽

10.1186/s12879-020-05507-4 ◽

2020 ◽

Vol 20 (1) ◽

Cited By ~ 5

Author(s):

Naser Gharebaghi ◽

Rahim Nejadrahim ◽

Seyed Jalil Mousavi ◽

Seyyed-Reza Sadat-Ebrahimi ◽

Reza Hajizadeh

Keyword(s):

Clinical Trial ◽

Mortality Rate ◽

Hospital Mortality ◽

Intravenous Immunoglobulin ◽

Initial Treatment ◽

Control Group ◽

Double Blind ◽

Link Type ◽

Double Blind Clinical Trial ◽

Laboratory Test Results

Abstract Background Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection. Methods This study was conducted as a randomized placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)—four vials daily for 3 days (in addition to initial treatment), while the other group received a placebo. Patients’ demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded. Results Among total study subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.025). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001–0.815]; P = 0.042). Conclusions Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment. Trial registration A study protocol was registered at the Iranian Registry of Clinical Trials (www.IRCT.ir), number IRCT20200501047259N1. It was registered retrospectively on May 17th, 2020.

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Rosa Damascena Improved Sexual Dysfunction in Males Under Methadone Treatment – Results From a Double-blind, Randomized, Placebo-controlled Clinical Trial

10.26226/morressier.588f0650d462b8028d892b11 ◽

2017 ◽

Author(s):

Serge Brand

Keyword(s):

Clinical Trial ◽

Sexual Dysfunction ◽

Methadone Treatment ◽

Controlled Clinical Trial ◽

Rosa Damascena ◽

Treatment Results ◽

Double Blind

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The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: A randomised placebo-controlled double-blind clinical trial

10.21203/rs.3.rs-40899/v2 ◽

2020 ◽

Author(s):

Naser Gharebaghi ◽

Rahim Nejadrahim ◽

Seyed Jalil Mousavi ◽

Seyyed-Reza Sadat-Ebrahimi ◽

Reza Hajizadeh

Keyword(s):

Clinical Trial ◽

Mortality Rate ◽

Hospital Mortality ◽

Intravenous Immunoglobulin ◽

Initial Treatment ◽

Control Group ◽

Double Blind ◽

Reduce Mortality Rate ◽

Double Blind Clinical Trial ◽

Laboratory Test Results

Abstract Background: Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection.Methods: This study was conducted as a randomised placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)—four vials daily for three days (in addition to initial treatment), while the other group received a placebo. Patients’ demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded. Results: Among the total subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001–0.815]; P = 0.042).Conclusions: Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment.Trial registration: A study protocol was registered at the Iranian Registry of Clinical Trials (www.IRCT.ir), number IRCT20200501047259N1. It was registered retrospectively on May 17th, 2020.

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