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

Identifieur interne : 000524 ( Main/Exploration ); précédent : 000523; suivant : 000525

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

Auteurs : Amirreza Roostaei Firozabad [Iran] ; Zohreh Akhoundi Meybodi [Iran] ; Seyed Ruhollah Mousavinasab [Iran] ; Adeleh Sahebnasagh [Iran] ; Mohsen Gholinataj Jelodar [Iran] ; Iman Karimzadeh [Iran] ; Solomon Habtemariam [Royaume-Uni] ; Fatemeh Saghafi [Iran]

Source :

RBID : pubmed:33761870

Descripteurs français

English descriptors

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).


DOI: 10.1186/s12879-021-05983-2
PubMed: 33761870
PubMed Central: PMC7988635


Affiliations:

Links toward previous steps (curation, corpus...)

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<b>BACKGROUND</b>
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<p>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.</p>
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<b>METHODS</b>
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<p>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.</p>
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<b>RESULTS</b>
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<p>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).</p>
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<b>CONCLUSION</b>
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<p>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.</p>
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<p>The trial was registered as IRCT20190810044500N7 (19/09/2020).</p>
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