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Inflammopharmacology
Feb, 2023;31 (1): 265-274.

Efficacy and safety of oral melatonin in patients with severe COVID-19: a randomized controlled trial.

Ali Ameri, Masoomeh Frouz Asadi, Ava Ziaei, Majid Vatankhah, Omid Safa, Manoochehr Kamali, Mohammad Fathalipour, Masoumeh Mahmoodi, Soheil Hassanipour
Author Information
  1. Ali Ameri: Student Research Committee, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
  2. Masoomeh Frouz Asadi: Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
  3. Ava Ziaei: Infectious and Tropical Diseases Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
  4. Majid Vatankhah: Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
  5. Omid Safa: Department of Clinical Pharmacy, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
  6. Manoochehr Kamali: Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. M.kamali@hums.ac.ir.
  7. Mohammad Fathalipour: Department of Pharmacology and Toxicology, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran. m.fathalipour@yahoo.com. ORCID
  8. Masoumeh Mahmoodi: Anesthesiology, Critical Care and Pain Management Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
  9. Soheil Hassanipour: Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.
PMID: 36401728 DOI: 10.1007/s10787-022-01096-7

Abstract

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.

Keywords

Antioxidant COVID-19 Cytokine storm Inflammation Melatonin

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Grants

  1. 990592/Hormozgan University of Medical Sciences

MeSH Term

Humans
COVID-19
Melatonin
SARS-CoV-2
Treatment Outcome

Chemicals

Melatonin
Randomized Controlled Trial Journal Article

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