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Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19 (COVID-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04474483
Recruitment Status : Recruiting
First Posted : July 16, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Margarita L. Dubocovich, PhD, State University of New York at Buffalo

Brief Summary:
This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Melatonin Other: Placebo (Methylcellulose) capsule Phase 2

Detailed Description:
This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of melatonin in outpatient adult patients suspected to be afflicted with COVID-19. Participants will be enrolled as outpatients within 72 hrs of onset of COVID-19 symptoms. The study will evaluate the safety of the intervention through 28 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), and/or discontinuation or temporary suspension of the investigational medication (for any reason). Additionally, the study will aim to evaluate the clinical efficacy of melatonin as compared to placebo as assessed by hospitalization, COVID-19 related symptoms and mortality. The ultimate goal is to determine in an adequately powered study if the anti-inflammatory and antioxidant actions of Melatonin can reduce the severity and prevent progression of COVID-19 when started in mild disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: placebo-controlled randomized double-blind pilot trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Placebo-controlled Randomized Double-blind Trial of Melatonin in Outpatients With COVID-19 Infection
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control
Placebo capsules will be prepared with opaque gelatin capsules, filled using methylcellulose and over-encapsulated to appear identical to interventional drug. Placebo capsules will be given orally in the same regimen as intervention (three times daily for 14 days). Capsules will be prepared by the research pharmacist and will be mailed to study subjects directly by courier. Placebo capsules will be stored at room temperature.
Other: Placebo (Methylcellulose) capsule
Placebo capsules will be prepared with opaque gelatin capsules, filled using methylcellulose and over-encapsulated to appear identical to interventional drug. Placebo capsules will be given orally in the same regimen as intervention (three times daily for 14 days). Capsules will be prepared by the research pharmacist and will be mailed to study subjects directly by courier. Placebo capsules will be stored at room temperature.
Other Name: Methylcellulose

Experimental: Melatonin
Melatonin will be administered orally as a 10 mg dose three times a day for 14 days. Size 4 clear vegetable cellulose capsules containing 10 mg melatonin, microcrystalline cellulose, and rice concentrate prepared by Life Extension® will be over-encapsulated in opaque gelatin capsules. Over-encapsulation of melatonin treatments will be done by the research pharmacist and will be mailed to study subjects directly by courier. Melatonin capsules will be stored at room temperature.
Drug: Melatonin
Melatonin will be administered orally as a 10 mg dose three times a day for 14 days. Size 4 clear vegetable cellulose capsules containing 10 mg melatonin, microcrystalline cellulose, and rice concentrate prepared by Life Extension® will be over-encapsulated in opaque gelatin capsules. Over-encapsulation of melatonin treatments will be done by the research pharmacist and will be mailed to study subjects directly by courier. Melatonin capsules will be stored at room temperature.
Other Name: 5-methoxy-N-acetyl tryptamine




Primary Outcome Measures :
  1. Cumulative Incidence of Treatment-Emergent Adverse Events [ Time Frame: 28 days ]
    Evaluate the incidence of serious adverse effects and discontinuation secondary to toxicity through 28 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).


Secondary Outcome Measures :
  1. Hospitalization [ Time Frame: 28 days ]
    Incidence of COVID-19 related hospitalization at 28 days

  2. COVID-19 related symptoms [ Time Frame: 28 days ]
    COVID-19 related symptoms (Fever, chills, cough, nasal symptoms, body aches/muscle aches, headache, loss of smell, loss of taste, nausea, vomiting, diarrhea, fatigue, dizziness) that are self-reported and on interview.

  3. Rate of resolution of COVID-19 related symptoms [ Time Frame: 28 days ]
    Change from baseline (day 1) as assessed to days 3, 7, 14, and 28

  4. Mortality [ Time Frame: 28 days ]
    28-day mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • Severe chronic liver disease
  • Severe chronic kidney disease or requiring dialysis
  • Pregnancy or breast feeding.
  • Allergy to the study medication
  • Currently taking melatonin
  • Currently taking high dose (>500 mg/day) Vitamin C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474483


Contacts
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Contact: Margarita L Dubocovich, Ph.D. (716) 829-3048 mdubo@buffalo.edu
Contact: Sanjay Sethi, MD (716) 888-4864 ssethi@buffalo.edu

Locations
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United States, New York
University at Buffalo Recruiting
Buffalo, New York, United States, 14203
Contact: Margarita Dubocovich, Ph.D.    716-829-3048    mdubo@buffalo.edu   
Contact: Sanjay Sethi, MD    (716) 888-4864    ssethi@buffalo.edu   
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
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Principal Investigator: Margarita L Dubocovich, Ph.D. University at Buffalo
Additional Information:
Publications:

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Responsible Party: Margarita L. Dubocovich, PhD, SUNY Distinguished Professor Dept of Pharmacology and Toxicology, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT04474483    
Other Study ID Numbers: UBMELCOVID19
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margarita L. Dubocovich, PhD, State University of New York at Buffalo:
Melatonin
COVID-19
SARS-CoV-2
Additional relevant MeSH terms:
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Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants