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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality 29% primary Improvement Relative Risk Ventilation 28% primary Clinical status 25% Recovery time 25% Hospitalization time 29% Melatonin  Ameri et al.  ICU PATIENTS  RCT Is very late treatment with melatonin beneficial for COVID-19? RCT 226 patients in Iran (March - November 2021) Lower mortality (p<0.0001) and ventilation (p=0.0027) c19early.org Ameri et al., Inflammopharmacology, Nov 2022 Favors melatonin Favors control

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

Ameri et al., Inflammopharmacology, doi:10.1007/s10787-022-01096-7
Nov 2022  
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Melatonin for COVID-19
10th treatment shown to reduce risk in December 2020
 
*, now known with p = 0.0000002 from 18 studies.
Lower risk for mortality, ventilation, and recovery.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,100+ studies for 60+ treatments. c19early.org
RCT 226 ICU patients in Iran, showing lower mortality with melatonin treatment.
risk of death, 28.8% lower, RR 0.71, p < 0.001, treatment 73 of 109 (67.0%), control 110 of 117 (94.0%), NNT 3.7, primary outcome.
risk of mechanical ventilation, 27.6% lower, RR 0.72, p = 0.003, treatment 56 of 109 (51.4%), control 83 of 117 (70.9%), NNT 5.1, primary outcome.
clinical status, 25.0% lower, RR 0.75, p = 0.001, treatment 109, control 117, day 14.
recovery time, 25.0% lower, relative time 0.75, p = 0.04, treatment 109, control 117.
hospitalization time, 28.6% lower, relative time 0.71, p = 0.03, treatment 109, control 117.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Ameri et al., 19 Nov 2022, Randomized Controlled Trial, Iran, peer-reviewed, 9 authors, study period 1 March, 2021 - 30 November, 2021.
This PaperMelatoninAll
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
Inflammopharmacology, doi:10.1007/s10787-022-01096-7
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.
Supplementary Information The online version contains supplementary material available at https:// doi. org/ 10. 1007/ s10787-022-01096-7. Author contributions AA, AZ, and MF: conceptualization, methodology, software. MF, MM, and SH: data curation, writing-original draft preparation. MF, MV, OS, and MK: visualization, investigation. AAi: supervision. SH: software, validation. MF: writing-reviewing and editing. Declarations Conflict of interest None of the authors have a conflict of interest to disclose. Ethical approval and consent to participate Ethics approval was obtained from the ethics committee of Hormozgan University of Medical Sciences (IR.HUMS.REC.1399.526). The study was also undertaken in accordance with the guidelines of the Declaration of Helsinki and the principles of the International Conference on Harmonization Good Clinical Practice. Consent for publication A written informed consent was obtained from all patients. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
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J ' 'Pineal Res 56:427–438', 'volume': '56', 'year': '2014'}, { 'DOI': '10.1203/00006450-200112000-00021', 'author': 'E Gitto', 'doi-asserted-by': 'publisher', 'first-page': '756', 'journal-title': 'Pediatr Res', 'key': '1096_CR20', 'unstructured': 'Gitto E, Karbownik M, Reiter RJ, Tan DX, Cuzzocrea S, Chiurazzi P, ' 'Cordaro S, Corona G, Trimarchi G, Barberi I (2001) Effects of melatonin ' 'treatment in septic newborns. Pediatr Res 50:756–760', 'volume': '50', 'year': '2001'}, { 'DOI': '10.1016/j.ijid.2021.10.012', 'author': 'ZT Hasan', 'doi-asserted-by': 'publisher', 'first-page': '79', 'journal-title': 'Int J Infect Dis', 'key': '1096_CR21', 'unstructured': 'Hasan ZT, Atrakji D, Mehuaiden DAK (2022) The effect of melatonin on ' 'thrombosis, sepsis and mortality rate in COVID-19 patients. Int J Infect ' 'Dis 114:79–84', 'volume': '114', 'year': '2022'}, { 'DOI': '10.1016/j.ctim.2018.06.002', 'author': 'R Henderson', 'doi-asserted-by': 'publisher', 'first-page': '131', 'journal-title': 'Complement Ther Med', 'key': '1096_CR22', 'unstructured': 'Henderson R, Kim S, Lee E (2018) Use of melatonin as adjunctive therapy ' 'in neonatal sepsis: a systematic review and meta-analysis. Complement ' 'Ther Med 39:131–136', 'volume': '39', 'year': '2018'}, { 'DOI': '10.1160/TH15-05-0396', 'author': 'PO Iversen', 'doi-asserted-by': 'publisher', 'first-page': '964', 'journal-title': 'Thromb Haemost', 'key': '1096_CR23', 'unstructured': 'Iversen PO, Dahm A, Skretting G, Mowinckel MC, Stranda A, Østerud B, ' 'Sandset PM, Kostovski E (2015) Reduced peak, but no diurnal variation, ' 'in thrombin generation upon melatonin supplementation in tetraplegia. A ' 'randomised, placebo-controlled study. Thromb Haemost 114:964–968', 'volume': '114', 'year': '2015'}, { 'DOI': '10.3390/nu12092561', 'author': 'K Kleszczyński', 'doi-asserted-by': 'publisher', 'first-page': '2561', 'journal-title': 'Nutrients', 'key': '1096_CR24', 'unstructured': 'Kleszczyński K, Slominski AT, Steinbrink K, Reiter RJ (2020) Clinical ' 'trials for use of melatonin to fight against COVID-19 are urgently ' 'needed. Nutrients 12:2561', 'volume': '12', 'year': '2020'}, { 'DOI': '10.1007/s12015-021-10322-8', 'author': 'R Kronstein-Wiedemann', 'doi-asserted-by': 'publisher', 'first-page': '1809', 'journal-title': 'Stem Cell Rev Rep', 'key': '1096_CR25', 'unstructured': 'Kronstein-Wiedemann R, Stadtmüller M, Traikov S, Georgi M, Teichert M, ' 'Yosef H, Wallenborn J, Karl A, Schütze K, Wagner M, El-Armouche A, Tonn ' 'T (2022) SARS-CoV-2 infects red blood cell progenitors and dysregulates ' 'hemoglobin and iron metabolism. Stem Cell Rev Rep 18:1809–1821', 'volume': '18', 'year': '2022'}, { 'DOI': '10.1111/j.1749-6632.2000.tb05421.x', 'author': 'P Lissoni', 'doi-asserted-by': 'publisher', 'first-page': '560', 'journal-title': 'Ann N Y Acad Sci', 'key': '1096_CR26', 'unstructured': 'Lissoni P (2000) Modulation of anticancer cytokines IL-2 and IL-12 by ' 'melatonin and the other pineal indoles 5-methoxytryptamine and ' '5-methoxytryptophol in the treatment of human neoplasms. Ann N Y Acad ' 'Sci 917:560–567', 'volume': '917', 'year': '2000'}, { 'DOI': '10.1007/s11255-020-02643-3', 'author': 'H Marzougui', 'doi-asserted-by': 'publisher', 'first-page': '553', 'journal-title': 'Int Urol Nephrol', 'key': '1096_CR27', 'unstructured': 'Marzougui H, Hammouda O, Bendhia I, Maaloul R, Agrebi I, Chaker H, ' 'Kammoun K, Benhmida M, Ayadi F, Kallel C, Driss T, Turki M, MasmoudI H, ' 'Hachicha H (2021) Melatonin ingestion before intradialytic exercise ' 'improves immune responses in hemodialysis patients. Int Urol Nephrol ' '53:553–562', 'volume': '53', 'year': '2021'}, { 'DOI': '10.1016/S2213-2600(21)00440-9', 'author': 'A Mazeraud', 'doi-asserted-by': 'publisher', 'first-page': '158', 'journal-title': 'Lancet Respir Med', 'key': '1096_CR28', 'unstructured': 'Mazeraud A, Jamme M, Mancusi RL, Latroche C, Megarbane B, Siami S, Zarka ' 'J, Moneger G, Santoli F, Argaud L, Chillet P, Muller G, Bruel C, Asfar ' 'P, Beloncle F, Reignier J, Vinsonneau C, Schimpf C, Amour J, Goulenok C, ' 'Lemaitre C, Rohaut B, Mateu P, de Rudnicki S, Mourvillier B, Declercq ' 'PL, Schwebel C, Stoclin A, Garnier M, Madeux B, Gaudry S, Bailly K, ' 'Lamer C, Aegerter P, Rieu C, Sylla K, Lucas B, Sharshar T (2022) ' 'Intravenous immunoglobulins in patients with COVID-19-associated ' 'moderate-to-severe acute respiratory distress syndrome (ICAR): ' 'multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet ' 'Respir Med 10:158–166', 'volume': '10', 'year': '2022'}, { 'author': 'AS Nair', 'first-page': '41', 'journal-title': 'Med Gas Res', 'key': '1096_CR29', 'unstructured': 'Nair AS (2022) Perioperative melatonin in COVID-19 patients: benefits ' 'beyond sedation and analgesia. Med Gas Res 12:41–43', 'volume': '12', 'year': '2022'}, { 'DOI': '10.1016/j.intimp.2020.106903', 'author': 'H Rahmani', 'doi-asserted-by': 'publisher', 'journal-title': 'Int Immunopharmacol', 'key': '1096_CR30', 'unstructured': 'Rahmani H, Davoudi-Monfared E, Nourian A, Khalili H, Hajizadeh N, ' 'Jalalabadi NZ, Fazeli MR, Ghazaeian M, Yekaninejad MS (2020) Interferon ' 'β-1b in treatment of severe COVID-19: a randomized clinical trial. Int ' 'Immunopharmacol 88:106903', 'volume': '88', 'year': '2020'}, { 'DOI': '10.32794/mr11250047', 'author': 'RJ Reiter', 'doi-asserted-by': 'publisher', 'first-page': '43', 'journal-title': 'Melatonin Res', 'key': '1096_CR31', 'unstructured': 'Reiter RJ, Ma Q, Sharma R (2020) Treatment of ebola and other infectious ' 'diseases: melatonin “goes viral.” Melatonin Res 3:43–57', 'volume': '3', 'year': '2020'}, { 'DOI': '10.1186/s13063-020-04632-4', 'author': 'M Rodríguez-Rubio', 'doi-asserted-by': 'publisher', 'first-page': '699', 'journal-title': 'Trials', 'key': '1096_CR32', 'unstructured': 'Rodríguez-Rubio M, Figueira JC, Acuña-Castroviejo D, Borobia AM, Escames ' 'G, de la Oliva P (2020) A phase II, single-center, double-blind, ' 'randomized placebo-controlled trial to explore the efficacy and safety ' 'of intravenous melatonin in patients with COVID-19 admitted to the ' 'intensive care unit (MelCOVID study): a structured summary of a study ' 'protocol for a randomized controlled trial. Trials 21:699', 'volume': '21', 'year': '2020'}, { 'DOI': '10.1016/j.arcmed.2018.12.004', 'author': 'AL Sánchez-López', 'doi-asserted-by': 'publisher', 'first-page': '391', 'journal-title': 'Arch Med Res', 'key': '1096_CR33', 'unstructured': 'Sánchez-López AL, Ortiz GG, Pacheco-Moises FP, Mireles-Ramírez MA, ' 'Bitzer-Quintero OK, Delgado-Lara DLC, Ramírez-Jirano LJ, ' 'Velázquez-Brizuela IE (2018) Efficacy of melatonin on serum ' 'pro-inflammatory cytokines and oxidative stress markers in relapsing ' 'remitting multiple sclerosis. Arch Med Res 49:391–398', 'volume': '49', 'year': '2018'}, { 'DOI': '10.1016/j.eclinm.2021.100763', 'author': 'D Seely', 'doi-asserted-by': 'publisher', 'journal-title': 'EClinicalMedicine', 'key': '1096_CR34', 'unstructured': 'Seely D, Legacy M, Auer RC, Fazekas A, Delic E, Anstee C, Angka L, ' 'Kennedy MA, Tai LH, Zhang T, Maziak DE, Shamji FM, Sundaresan RS, ' 'Gilbert S, Villeneuve PJ, Ashrafi AS, Inculet R, Yasufuku K, Waddell TK, ' 'Finley C, Shargall Y, Plourde M, Fergusson DA, Ramsay T, Seely AJE ' '(2021) Adjuvant melatonin for the prevention of recurrence and mortality ' 'following lung cancer resection (AMPLCaRe): a randomized placebo ' 'controlled clinical trial. EClinicalMedicine 33:100763', 'volume': '33', 'year': '2021'}, { 'DOI': '10.1016/j.mehy.2021.110722', 'author': 'A Sen', 'doi-asserted-by': 'publisher', 'journal-title': 'Med Hypotheses', 'key': '1096_CR35', 'unstructured': 'Sen A (2021) Deficient synthesis of melatonin in COVID-19 can impair the ' 'resistance of coronavirus patients to mucormycosis. Med Hypotheses ' '158:110722', 'volume': '158', 'year': '2021'}, { 'DOI': '10.1034/j.1600-079X.2003.00068.x', 'author': 'SY Shiu', 'doi-asserted-by': 'publisher', 'first-page': '69', 'journal-title': 'J Pineal Res', 'key': '1096_CR36', 'unstructured': 'Shiu SY, Reiter RJ, Tan DX, Pang SF (2003) Urgent search for safe and ' 'effective treatments of severe acute respiratory syndrome: is melatonin ' 'a promising candidate drug? J Pineal Res 35:69–70', 'volume': '35', 'year': '2003'}, { 'DOI': '10.1080/08830185.2020.1756284', 'author': 'A Shneider', 'doi-asserted-by': 'publisher', 'first-page': '153', 'journal-title': 'Int Rev Immunol', 'key': '1096_CR37', 'unstructured': 'Shneider A, Kudriavtsev A, Vakhrusheva A (2020) Can melatonin reduce the ' 'severity of COVID-19 pandemic? Int Rev Immunol 39:153–162', 'volume': '39', 'year': '2020'}, { 'DOI': '10.1111/j.1600-079X.2007.00535.x', 'author': 'PH Wirtz', 'doi-asserted-by': 'publisher', 'first-page': '358', 'journal-title': 'J Pineal Res', 'key': '1096_CR38', 'unstructured': 'Wirtz PH, Bärtschi C, Spillmann M, Ehlert U, von Känel R (2008) Effect ' 'of oral melatonin on the procoagulant response to acute psychosocial ' 'stress in healthy men: a randomized placebo-controlled study. J Pineal ' 'Res 44:358–365', 'volume': '44', 'year': '2008'}, { 'DOI': '10.1016/j.lfs.2020.117583', 'author': 'R Zhang', 'doi-asserted-by': 'publisher', 'journal-title': 'Life Sci', 'key': '1096_CR39', 'unstructured': 'Zhang R, Wang X, Ni L, Di X, Ma B, Niu S, Liu C, Reiter RJ (2020) ' 'COVID-19: melatonin as a potential adjuvant treatment. Life Sci ' '250:117583', 'volume': '250', 'year': '2020'}, { 'DOI': '10.1111/jpi.12322', 'author': 'Y Zhang', 'doi-asserted-by': 'publisher', 'first-page': '405', 'journal-title': 'J Pineal Res', 'key': '1096_CR40', 'unstructured': 'Zhang Y, Li X, Grailer JJ, Wang N, Wang M, Yao J, Zhong R, Gao GF, Ward ' 'PA, Tan DX, Li X (2016) Melatonin alleviates acute lung injury through ' 'inhibiting the NLRP3 inflammasome. J Pineal Res 60:405–414', 'volume': '60', 'year': '2016'}, { 'DOI': '10.1111/bph.14116', 'author': 'Y Zisapel', 'doi-asserted-by': 'publisher', 'first-page': '3190', 'journal-title': 'Br J Pharmacol', 'key': '1096_CR41', 'unstructured': 'Zisapel Y (2018) New perspectives on the role of melatonin in human ' 'sleep, circadian rhythms and their regulation. Br J Pharmacol ' '175:3190–3199', 'volume': '175', 'year': '2018'}], 'reference-count': 41, 'references-count': 41, 'relation': {}, 'resource': {'primary': {'URL': 'https://link.springer.com/10.1007/s10787-022-01096-7'}}, 'score': 1, 'short-title': [], 'source': 'Crossref', 'subject': ['Pharmacology (medical)', 'Pharmacology', 'Immunology'], 'subtitle': [], 'title': 'Efficacy and safety of oral melatonin in patients with severe COVID-19: a randomized controlled ' 'trial', 'type': 'journal-article', 'update-policy': 'http://dx.doi.org/10.1007/springer_crossmark_policy'}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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