Effect of Ammonium Chloride in addition to standard of care in outpatients and hospitalized COVID-19 patients: A randomized clinical trial

Objective: The COVID-19 pandemic has called an urgent need for drug repurposing to improve the outcome of the disease. Quaternary ammonium compounds have been demonstrated to have antiviral effects and may be of use against SARS-CoV-2 infections. Design: In this double-blind, single-center study, we...

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Main Authors: Zeinab Siami, Sepehr Aghajanian, Somayeh Mansouri, Zakiye Mokhames, Reza Pakzad, Kourosh Kabir, Mehdi Norouzi, Alireza Soleimani, Mojtaba Hedayat Yaghoobi, Shahrzad Shadabi, Ramin Tajbakhsh, Ali Kargar Kheirabad, Sayed-Hamidreza Mozhgani
Format: Article
Language:English
Published: Elsevier 2021-07-01
Series:International Journal of Infectious Diseases
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S1201971221003544
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spelling doaj-f6e5921ba43744c88b21fefeb8ec74b92021-07-23T04:47:14ZengElsevierInternational Journal of Infectious Diseases1201-97122021-07-01108306308Effect of Ammonium Chloride in addition to standard of care in outpatients and hospitalized COVID-19 patients: A randomized clinical trialZeinab Siami0Sepehr Aghajanian1Somayeh Mansouri2Zakiye Mokhames3Reza Pakzad4Kourosh Kabir5Mehdi Norouzi6Alireza Soleimani7Mojtaba Hedayat Yaghoobi8Shahrzad Shadabi9Ramin Tajbakhsh10Ali Kargar Kheirabad11Sayed-Hamidreza Mozhgani12Department of Infectious Diseases, School of Medicine, Alborz University of Medical Sciences, Karaj, IranStudent Research Committee, Alborz University of Medical Sciences, Karaj, IranStudent Research Committee, Alborz University of Medical Sciences, Karaj, IranDepartment of Molecular Diagnostics, Emam Ali Educational and Therapeutic Center, Alborz University of Medical Sciences, Karaj, IranDepartment of Epidemiology, Faculty of Health, Ilam University of Medical Sciences, Ilam, Iran; Student Research Committee, Ilam University of Medical Sciences, Ilam, IranDepartment of Community Medicine, School of Medicine, Alborz University of Medical Sciences, Karaj, IranDepartment of Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran; Research Center for Clinical Virology, Tehran University of Medical Sciences, Tehran, IranDepartment of Infectious Diseases, School of Medicine, Alborz University of Medical Sciences, Karaj, IranDepartment of Infectious Diseases, School of Medicine, Alborz University of Medical Sciences, Karaj, IranStudent Research Committee, Alborz University of Medical Sciences, Karaj, IranDepartment of Internal Medicine, School of Medicine, Imam Ali Hospital, Alborz University of Medical Sciences, Karaj, IranDepartment of Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran; Corresponding author at: Department of Virology, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.Non-communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran; Department of Microbiology, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran; Corresponding author at: Department of Microbiology, School of Medicine, Alborz University of Medical Sciences, Karaj, Iran.Objective: The COVID-19 pandemic has called an urgent need for drug repurposing to improve the outcome of the disease. Quaternary ammonium compounds have been demonstrated to have antiviral effects and may be of use against SARS-CoV-2 infections. Design: In this double-blind, single-center study, we enrolled patients with positive PCR test and/or CT findings for COVID-19. The participants of each group were randomly assigned to Diphenhydramine Compound (Diphenhydramine + Ammonium Chloride) plus standard of care or to Diphenhydramine alone and standard of care groups. The primary outcome was all-cause mortality within 30 days of randomization. Secondary outcomes include viral burden, clinical status, assessed by a 5-point ordinal scale, and length of stay in hospitalized patients. Results: A total of 120 patients were included in the trial, 60 of which were assigned to the Ammonium Chloride group. The primary endpoint was not statistically different between the two groups (HR: 3.02 (95% CI, 0.57–16.06; p = 0.195)). Recovery time and viral burden were significantly lower in the Ammonium Chloride group, corresponding to an odds ratios of 1.8 (95% CI, 1.15–2.83; p = 0.01) and 7.90 (95% CI, 1.62–14.17; p = 0.014), respectively. Conclusion: The findings of this study advocate the careful addition of Ammonium Chloride to standard of care for COVID-19 patients.http://www.sciencedirect.com/science/article/pii/S1201971221003544COVID-19Ammonium ChlorideSARS-CoV-2Randomized clinical trialLysosomotropic agents
collection DOAJ
language English
format Article
sources DOAJ
author Zeinab Siami
Sepehr Aghajanian
Somayeh Mansouri
Zakiye Mokhames
Reza Pakzad
Kourosh Kabir
Mehdi Norouzi
Alireza Soleimani
Mojtaba Hedayat Yaghoobi
Shahrzad Shadabi
Ramin Tajbakhsh
Ali Kargar Kheirabad
Sayed-Hamidreza Mozhgani
spellingShingle Zeinab Siami
Sepehr Aghajanian
Somayeh Mansouri
Zakiye Mokhames
Reza Pakzad
Kourosh Kabir
Mehdi Norouzi
Alireza Soleimani
Mojtaba Hedayat Yaghoobi
Shahrzad Shadabi
Ramin Tajbakhsh
Ali Kargar Kheirabad
Sayed-Hamidreza Mozhgani
Effect of Ammonium Chloride in addition to standard of care in outpatients and hospitalized COVID-19 patients: A randomized clinical trial
International Journal of Infectious Diseases
COVID-19
Ammonium Chloride
SARS-CoV-2
Randomized clinical trial
Lysosomotropic agents
author_facet Zeinab Siami
Sepehr Aghajanian
Somayeh Mansouri
Zakiye Mokhames
Reza Pakzad
Kourosh Kabir
Mehdi Norouzi
Alireza Soleimani
Mojtaba Hedayat Yaghoobi
Shahrzad Shadabi
Ramin Tajbakhsh
Ali Kargar Kheirabad
Sayed-Hamidreza Mozhgani
author_sort Zeinab Siami
title Effect of Ammonium Chloride in addition to standard of care in outpatients and hospitalized COVID-19 patients: A randomized clinical trial
title_short Effect of Ammonium Chloride in addition to standard of care in outpatients and hospitalized COVID-19 patients: A randomized clinical trial
title_full Effect of Ammonium Chloride in addition to standard of care in outpatients and hospitalized COVID-19 patients: A randomized clinical trial
title_fullStr Effect of Ammonium Chloride in addition to standard of care in outpatients and hospitalized COVID-19 patients: A randomized clinical trial
title_full_unstemmed Effect of Ammonium Chloride in addition to standard of care in outpatients and hospitalized COVID-19 patients: A randomized clinical trial
title_sort effect of ammonium chloride in addition to standard of care in outpatients and hospitalized covid-19 patients: a randomized clinical trial
publisher Elsevier
series International Journal of Infectious Diseases
issn 1201-9712
publishDate 2021-07-01
description Objective: The COVID-19 pandemic has called an urgent need for drug repurposing to improve the outcome of the disease. Quaternary ammonium compounds have been demonstrated to have antiviral effects and may be of use against SARS-CoV-2 infections. Design: In this double-blind, single-center study, we enrolled patients with positive PCR test and/or CT findings for COVID-19. The participants of each group were randomly assigned to Diphenhydramine Compound (Diphenhydramine + Ammonium Chloride) plus standard of care or to Diphenhydramine alone and standard of care groups. The primary outcome was all-cause mortality within 30 days of randomization. Secondary outcomes include viral burden, clinical status, assessed by a 5-point ordinal scale, and length of stay in hospitalized patients. Results: A total of 120 patients were included in the trial, 60 of which were assigned to the Ammonium Chloride group. The primary endpoint was not statistically different between the two groups (HR: 3.02 (95% CI, 0.57–16.06; p = 0.195)). Recovery time and viral burden were significantly lower in the Ammonium Chloride group, corresponding to an odds ratios of 1.8 (95% CI, 1.15–2.83; p = 0.01) and 7.90 (95% CI, 1.62–14.17; p = 0.014), respectively. Conclusion: The findings of this study advocate the careful addition of Ammonium Chloride to standard of care for COVID-19 patients.
topic COVID-19
Ammonium Chloride
SARS-CoV-2
Randomized clinical trial
Lysosomotropic agents
url http://www.sciencedirect.com/science/article/pii/S1201971221003544
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