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Randomized Controlled Trial
. 2021 Sep 15;22(1):245.
doi: 10.1186/s12931-021-01833-6.

The efficacy of corticosteroids therapy in patients with moderate to severe SARS-CoV-2 infection: a multicenter, randomized, open-label trial

Mostafa Ghanei  1 , Masoud Solaymani-Dodaran  2   3   4 , Ali Qazvini  5 , Amir Hosein Ghazale  6 , Seyed Amin Setarehdan  2   4 , Seyed Hassan Saadat  7 , Hassan Ghobadi  8 , Saeed Hoseininia  8 , Maryam Elahikhah  6 , Ali Hossein Samadi  8 , Yousef Imani  9 , Ensieh Vahedi  10 , Farhang Babamahmoodi  11 , Fatemeh Tajik Rostami  12 , Mohammad Hossein Azimzadeh Ardebili  6 , Akram Ansarifar  4 , Fatemeh Fallahpoor Golmaei  13 , Atieh Asadollah  6
Affiliations
Randomized Controlled Trial

The efficacy of corticosteroids therapy in patients with moderate to severe SARS-CoV-2 infection: a multicenter, randomized, open-label trial

Mostafa Ghanei et al. Respir Res. .

Abstract

Background: We performed a multicenter, randomized open-label trial in patients with moderate to severe Covid-19 treated with a range of possible treatment regimens.

Methods: Patients were randomly assigned to one of three regimen groups at a ratio of 1:1:1. The primary outcome of this study was admission to the intensive care unit. Secondary outcomes were intubation, in-hospital mortality, time to clinical recovery, and length of hospital stay (LOS). Between April 13 and August 9, 2020, a total of 336 patients were randomly assigned to receive one of the 3 treatment regimens including group I (hydroxychloroquine stat, prednisolone, azithromycin and naproxen; 120 patients), group II (hydroxychloroquine stat, azithromycin and naproxen; 116 patients), and group III (hydroxychloroquine and lopinavir/ritonavir (116 patients). The mean LOS in patients receiving prednisolone was 5.5 in the modified intention-to-treat (mITT) population and 4.4 days in the per-protocol (PP) population compared with 6.4 days (mITT population) and 5.8 days (PP population) in patients treated with Lopinavir/Ritonavir.

Results: The mean LOS was significantly lower in the mITT and PP populations who received prednisolone compared with populations treated with Lopinavir/Ritonavir (p = 0.028; p = 0.0007). We observed no significant differences in the number of deaths, ICU admission, and need for mechanical ventilation between the Modified ITT and per-protocol populations treated with prednisolone and Lopinavir/Ritonavir, although these outcomes were better in the arm treated with prednisolone. The time to clinical recovery was similar in the modified ITT and per-protocol populations treated with prednisolone, lopinavir/ritonavir, and azithromycin (P = 0.335; P = 0.055; p = 0.291; p = 0.098).

Conclusion: The results of the present study show that therapeutic regimen (regimen I) with low dose prednisolone was superior to other regimens in shortening the length of hospital stay in patients with moderate to severe COVID-19. The steroid sparing effect may be utilized to increase the effectiveness of corticosteroids in the management of diabetic patients by decreasing the dosage.

Keywords: Anti-inflammatory drugs; COVID-19; Corticosteroids; Low dose prednisolone.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Participants flow diagram
Fig. 2
Fig. 2
Kaplan–Meier and Nelson-Allen curves for Modified ITT and perprotocol populations by intervention groups; death/mechanical ventilation in the Modified ITT (Kaplan–Meier estimate, part a), and perprotocol populations (Part b), cumulative probability of discharge in Modified ITT and perprotocol population (Nelson-Allen, parts c and d), cumulative probability clinical recovery in the Modified ITT population and perprotocol populations (Parts e and f)
See this image and copyright information in PMC

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