Melatonin in the Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers (MeCOVID): A Randomised Clinical Trial
et al., Journal of Clinical Medicine, doi:10.3390/jcm11041139, MeCOVID, NCT04353128, Feb 2022
Melatonin for COVID-19
11th treatment shown to reduce risk in
December 2020, now with p = 0.000000011 from 20 studies.
No treatment is 100% effective. Protocols
combine treatments.
6,200+ studies for
200+ treatments. c19early.org
|
PrEP RCT healthcare workers in Spain, showing no significant
difference in cases with melatonin prophylaxis. Most cases were asymptomatic
or paucisymtomatic, there were two symptomatic cases, no moderate/severe
cases, and no hospitalization.
The registered primary outcome is symptomatic cases. Authors
report on all cases due to the small number of symptomatic cases. They did not
include the original primary outcome results in the paper, but have provided
the results via email to a contributor.
The dosage in this trial is very low, 2mg daily. Meta
regression suggests higher doses are much more effective. EudraCT
2020-001530-35.
|
risk of symptomatic case, 7.4% lower, RR 0.93, p = 1.00, treatment 1 of 163 (0.6%), control 1 of 151 (0.7%), NNT 2051, primary outcome.
|
|
risk of case, 108.4% higher, RR 2.08, p = 0.26, treatment 9 of 163 (5.5%), control 4 of 151 (2.6%), post-hoc primary outcome.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
García-García et al., 21 Feb 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Spain, peer-reviewed, 25 authors, study period April 2020 - December 2020, trial NCT04353128 (history) (MeCOVID).
Melatonin in the Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers (MeCOVID): A Randomised Clinical Trial
We evaluated in this randomised, double-blind clinical trial the efficacy of melatonin as a prophylactic treatment for prevention of SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 exposure. Healthcare workers fulfilling inclusion criteria were recruited in five hospitals in Spain and were randomised 1:1 to receive melatonin 2 mg administered orally for 12 weeks or placebo. The main outcome was the number of SARS-CoV-2 infections. A total of 344 volunteers were screened, and 314 were randomised: 151 to placebo and 163 to melatonin; 308 received the study treatment (148 placebo; 160 melatonin). We detected 13 SARS-CoV-2 infections, 2.6% in the placebo arm and 5.5% in the melatonin arm (p = 0.200). A total of 294 adverse events were detected in 127 participants (139 in placebo; 155 in melatonin). We found a statistically significant difference in the incidence of adverse events related to treatment: 43 in the placebo arm and 67 in the melatonin arm (p = 0.040), and in the number of participants suffering from somnolence related to treatment: 8.8% (n = 14) in the melatonin versus 1.4% (n = 2) in the placebo arm (p = 0.008). No severe adverse
Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.
Conflicts of Interest: The authors declare no conflict of interest.
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"abstract": "<jats:p>We evaluated in this randomised, double-blind clinical trial the efficacy of melatonin as a prophylactic treatment for prevention of SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 exposure. Healthcare workers fulfilling inclusion criteria were recruited in five hospitals in Spain and were randomised 1:1 to receive melatonin 2 mg administered orally for 12 weeks or placebo. The main outcome was the number of SARS-CoV-2 infections. A total of 344 volunteers were screened, and 314 were randomised: 151 to placebo and 163 to melatonin; 308 received the study treatment (148 placebo; 160 melatonin). We detected 13 SARS-CoV-2 infections, 2.6% in the placebo arm and 5.5% in the melatonin arm (p = 0.200). A total of 294 adverse events were detected in 127 participants (139 in placebo; 155 in melatonin). We found a statistically significant difference in the incidence of adverse events related to treatment: 43 in the placebo arm and 67 in the melatonin arm (p = 0.040), and in the number of participants suffering from somnolence related to treatment: 8.8% (n = 14) in the melatonin versus 1.4% (n = 2) in the placebo arm (p = 0.008). No severe adverse events related to treatment were reported. We cannot confirm our hypothesis that administration of melatonin prevents the development of SARS-CoV-2 infection in healthcare workers.</jats:p>",
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