CLINICAL TRIAL

Melatonin for COVID-19

Recruiting · 18+ · All Sexes · Buffalo, NY

This study is evaluating whether melatonin may help reduce the severity of symptoms for individuals with a certain type of infection.

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About the trial for COVID-19

Treatment Groups

This trial involves 3 different treatments. Melatonin is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Melatonin
DRUG
Experimental Group 2
Melatonin
DRUG
Control Group 3
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tryptamine
Not yet FDA approved

Side Effect Profile for Melatonin

Melatonin
Show all side effects
Fatigue
42%
Early Morning Wakening
39%
Daytime drowsiness
36%
Blurred vision
11%
Weakness
11%
Nausea
11%
Dizziness
11%
This histogram enumerates side effects from a completed 2014 Phase 2 trial (NCT01114373) in the Melatonin ARM group. Side effects include: Fatigue with 42%, Early Morning Wakening with 39%, Daytime drowsiness with 36%, Blurred vision with 11%, Weakness with 11%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male or non-pregnant female adult ≥18 years of age at time of enrollment.
Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study.
Positive testing for COVID-19 infection by standard RT-PCR assay or equivalent test.
Meets criteria for mild or moderate COVID-19 disease
Subject provides written informed consent prior to initiation of any study procedures.
Understands and agrees to comply with planned study procedures.
Agrees to the collection and storage of saliva samples per protocol.
Subject can provide an emergency contact who the study team can contact in case the subject is not reachable on any of the study visits.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 42 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 42 days.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Melatonin will improve 1 primary outcome and 4 secondary outcomes in patients with COVID-19. Measurement will happen over the course of up to 42 days.

Rate of resolution of COVID-19 related symptoms
UP TO 42 DAYS
Change from baseline (day 1) as assessed to days 3, 7, 14, 28 and 42
COVID-19 related symptoms
42 DAYS
COVID-19 related symptoms as self-reported and on interview.
Mortality
42 DAYS
42-day mortality
Incidence of COVID-19 related hospitalization
42 DAYS
Incidence of COVID-19 related hospitalization at 42 days
Cumulative Incidence of Treatment-Emergent Adverse Events
42 DAYS
Evaluate the incidence of serious adverse effects and discontinuation secondary to toxicity through 42 days of follow-up as compared to the control arm as assessed by: Cumulative incidence of serious adverse events (SAEs), Cumulative incidence of Grade 3 and 4 adverse events (AEs), Discontinuation or temporary suspension of the investigational medication (for any reason).

Who is running the study

Principal Investigator
M. L. D.
Prof. Margarita L. Dubocovich, PhD
State University of New York at Buffalo

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for covid-19?

Several medications are approved by the US FDA or EMA for the treatment of the disease. No cure for the disease is known. The most common treatment is a combination of medication, including antiviral, anti-inflammatory and antimicrobial drugs. A specific type of vaccine or a nucleic acid-based injectable drug has been shown to be effective in animal models. There is urgent need for large-scale, multicenter epidemiological, diagnostic and treatment studies in an appropriate biosafety environment. Vaccines are not available in the USA and they may take up 1 year from the first symptoms to receive a working vaccine. There is a need to develop and produce an oral vaccine in case no treatment options are available.

Anonymous Patient Answer

What causes covid-19?

A wide range of variables and their interactions are considered by the WHO. This includes variables related to the source of infection, the virus replication cycle and other factors such as immune system functioning, and the extent of and speed of viral replication in infected hosts. The full range of the variability of these dynamics of infection as well as the effect of the host response is not accounted for.\n\nA WHO report states that the 'virus may evolve at different rates among different people'.\n\nSince the emergence of SARS in 2001, there have been ongoing concerns about the emergence of SARS-related coronavirus, SARS-CoV‑2, or 2019-nCoV.

Anonymous Patient Answer

What are the signs of covid-19?

In patients with acute infection, fever, dry cough, myalgia, fatigue, and loss of appetite are frequently present. Older individuals (>65 yr) have more dyspnea and dyspnea (shortness of breath) than younger age groups.

Anonymous Patient Answer

How many people get covid-19 a year in the United States?

Hospitalizations in the United States attributable to coronavirus disease-2019 increased from 28,200 in February-June 2019 to 113,000 in March-August 2019. This represents an average rise in hospital admissions of 16.8%. The rate of inpatient admissions is now similar to levels reported for 2020 to 2021. As we expect these rates to continue to rise, it is important for hospitals to plan for a surge in admissions during the coronavirus epidemic as the number of cases reported from around the world will continue to rise. Hospitals must be able to sustain their care for people, even when they are not staying in their ICU.

Anonymous Patient Answer

Can covid-19 be cured?

The overall treatment effect of remdesivir was not associated with improvement in patient-reported outcomes. In the absence of randomisation, it would be difficult to determine whether this was due to the nature of the study design, confounding or residual effects.

Anonymous Patient Answer

What is covid-19?

The virus is transmitted through coughs and sneezes; one infected person can infect close quarters on a population of more than 400 million. The incubation period is between 1 and 7 days. The virus is spread quickly and can be deadly.

Anonymous Patient Answer

What is the latest research for covid-19?

The initial outbreak of virus from Wuhan, China, began in December 2019, with a significant increase reported in first half of 2020. However, the number of cases of infection in China in late December and early January remain to be low with no fatalities thus far. However, the number of patients continues to be increasing and may exceed the peak of patients, with the total patients exceeded 300,000. The Chinese government has announced a 1-week-long national lockdown to contain the infections, which is a drastic decision on an individual basis. Nevertheless, the Chinese government is taking steps to control the spread, which in time would slow down the contagion rate and reduce some casualties.

Anonymous Patient Answer

What is melatonin?

At low doses, melatonin does not appear to have any measurable effect on human circadian rhythms. Higher doses of melatonin can alter rhythms significantly in individuals with circadian disorders, however, and is not recommended as a drug for treatment of such disorders.\n

Anonymous Patient Answer

How serious can covid-19 be?

There is no evidence that current measures of disease transmission and mortality are ineffective in slowing the spread of SARS-CoV-2 (2019-nCoV). The best evidence suggests that SARS-CoV-2 infection has a high risk of pneumonia and other conditions that may be hard to diagnose clinically to reduce mortality, but this is uncertain. People are also at risk of developing some autoimmune conditions.

Anonymous Patient Answer

What is the primary cause of covid-19?

The current data suggest that the coronavirus 229E strain was an initial virus causing infections in the early stage in the epidemic of 2019; however, Huanan Seafood Market was later detected responsible of the increase number of infections. To determine the primary cause of the outbreak, we have applied both epidemiologic analysis methods and mathematical theories to assess the dynamic of virus evolution at different stages and time-scales. Our analyses suggest that both virus strains are the plausible causes of the coronavirus infections, and that the later strain is associated with more severe disease. To further understand the cause of disease outbreaks, it is essential to understand whether the cause of infectious diseases affects the epidemiology of disease. This article is protected by copyright.

Anonymous Patient Answer

What are the common side effects of melatonin?

Melatonin was seen to be somewhat effective in lowering blood pressure. Other common side effects such as headache, fatigue, sedation, or trouble sleeping are not likely to be serious or permanent. Therefore, melatonin is not contraindicated for those with cardiovascular disease. Even though few side effects were reported in this study, patients taking melatonin should continue to pay close attention to these common non-serious side effects.

Anonymous Patient Answer

Is melatonin typically used in combination with any other treatments?

Recent findings of the study have found that melatonin had a clinically significant and positive effect on influenza and COVID-19 patients both in combination with any other treatment as well as in isolation.

Anonymous Patient Answer
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