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Efficacy and safety of oral melatonin in patients with severe COVID-19: a randomized controlled trial
被引:18
作者:
Ameri, Ali
[1
]
Asadi, Masoomeh Frouz
[2
,3
]
Ziaei, Ava
[3
]
Vatankhah, Majid
[2
]
Safa, Omid
[4
]
Kamali, Manoochehr
[2
,3
]
Fathalipour, Mohammad
[5
,6
]
Mahmoodi, Masoumeh
[2
]
Hassanipour, Soheil
[7
]
机构:
[1] Hormozgan Univ Med Sci, Fac Pharm, Student Res Comm, Bandar Abbas, Iran
[2] Hormozgan Univ Med Sci, Anesthesiol Crit Care & Pain Management Res Ctr, Bandar Abbas, Iran
[3] Hormozgan Univ Med Sci, Infect & Trop Dis Res Ctr, Hormozgan Hlth Inst, Bandar Abbas, Iran
[4] Hormozgan Univ Med Sci, Fac Pharm, Dept Clin Pharm, Bandar Abbas, Iran
[5] Hormozgan Univ Med Sci, Fac Pharm, Dept Pharmacol & Toxicol, Bandar Abbas, Iran
[6] Hormozgan Univ Med Sci, Endocrinol & Metab Res Ctr, Bandar Abbas, Iran
[7] Guilan Univ Med Sci, Gastrointestinal & Liver Dis Res Ctr, Rasht, Iran
关键词:
Melatonin;
COVID-19;
Cytokine storm;
Inflammation;
Antioxidant;
SUPPLEMENTATION;
THERAPY;
STRESS;
SEPSIS;
D O I:
10.1007/s10787-022-01096-7
中图分类号:
R392 [医学免疫学];
Q939.91 [免疫学];
学科分类号:
100102 ;
摘要:
Patients with COVID-19 have shown melatonin deficiency. We evaluated the efficacy and safety of administration oral melatonin in patients with COVID-19-induced pneumonia. Patients were randomly assigned in a 1:1 ratio to receive melatonin plus standard treatment or standard treatment alone. The primary outcomes were mortality rate and requirement of IMV. The clinical status of patients was recorded at baseline and every day over hospitalization based on seven-category ordinal scale from 1 (discharged) to 7 (death). A total of 226 patients (109 in the melatonin group and 117 in the control group) were enrolled (median age; in melatonin group: 54.60 +/- 11.51, in control group: 54.69 +/- 13.40). The mortality rate was 67% in the melatonin group and 94% in the control group (OR; 7.75, 95% CI, 3.27-18.35, P < 0.001). The rate of IMV requirement was 51.4% in the melatonin group and 70.9% in the control group, for an OR of 2.31 (95% CI, 1.34-4.00, P < 0.001). The median number of days to hospital discharge was 15 days (13-17) in the melatonin group and 21 days (14-24) in the control group (OR; 5.00, 95% CI, 0.15-9.84, P = 0.026). Time to clinical status improvement by >= 2 on the ordinal scale in was 12 days (9-13) in the melatonin group and 16 days (10-19) in the control group (OR; 3.92, 95% CI, 1.69-6.14, P = 0.038). Melatonin significantly improved clinical status with a safe profile in patients with severe COVID-19 pneumonia.
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页码:265 / 274
页数:10
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