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Open Access 01-12-2021 | Dyspnea | Research article

Efficacy and safety of Levamisole treatment in clinical presentations of non-hospitalized patients with COVID-19: a double-blind, randomized, controlled trial

Authors: Amirreza Roostaei Firozabad, Zohreh Akhoundi Meybodi, Seyed Ruhollah Mousavinasab, Adeleh Sahebnasagh, Mohsen Gholinataj Jelodar, Iman Karimzadeh, Solomon Habtemariam, Fatemeh Saghafi

Published in: BMC Infectious Diseases | Issue 1/2021

Abstract

Background

Levamisole has shown clinical benefits in the management of COVID-19 via its immunomodulatory effect. However, the exact role of Levamisole effect in clinical status of COVID-19 patients is unknown. We aimed to evaluate the efficacy of Levamisole on clinical status of patients with COVID-19 during their course of the disease.

Methods

This prospective, double-blind, randomized controlled clinical trial was performed in adult patients with mild to moderate COVID-19 (room-air oxygen saturation > 94%) from late April 2020 to mid-August 2020. Patients were randomly assigned to receive a 3-day course of Levamisole or placebo in combination with routine standard of care.

Results

With 25 patients in each arm, 50 patients with COVID-19 were enrolled in the study. Most of the study participants were men (60%). On days 3 and 14, patients in Levamisole group had significantly better cough status distribution when compared to the placebo group (P-value = 0.034 and 0.005, respectively). Moreover, there was significant differences between the two groups in dyspnea at follow-up intervals of 7 (P-value = 0.015) and 14 (P-value = 0.010) days after receiving the interventions. However, no significant difference in fever status was observed on days 1, 3, 7, and 14 in both groups (P-value > 0.05).

Conclusion

The results of the current study suggest that Levamisole may improve most of clinical status of patients with COVID-19. The patients receiving Levamisole had significantly better chance of clinical status including cough and dyspnea on day 14 when compared to the placebo. However, the effect-size of this finding has uncertain clinical importance.

Trial registration

The trial was registered as IRCT20190810044500N7 (19/09/2020).

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Title: Efficacy and safety of Levamisole treatment in clinical presentations of non-hospitalized patients with COVID-19: a double-blind, randomized, controlled trial
Authors: Amirreza Roostaei Firozabad
Zohreh Akhoundi Meybodi
Seyed Ruhollah Mousavinasab
Adeleh Sahebnasagh
Mohsen Gholinataj Jelodar
Iman Karimzadeh
Solomon Habtemariam
Fatemeh Saghafi
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Dyspnea
Cough
Care
Cough
Cough
Dyspnea
COVID-19
Hydroxychloroquine
Published in: BMC Infectious Diseases / Issue 1/2021
Electronic ISSN: 1471-2334
DOI: https://doi.org/10.1186/s12879-021-05983-2

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Methods

Results

Conclusion

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