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

Sponsor
State University of New York at Buffalo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04474483
Collaborator
(none)
30
1
2
25.8
1.2

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
placebo-controlled randomized double-blind pilot trialplacebo-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 :
Nov 6, 2020
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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 Names:
  • 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 Names:
  • 5-methoxy-N-acetyl tryptamine
  • Outcome Measures

    Primary Outcome Measures

    1. Cumulative Incidence of Treatment-Emergent Adverse Events [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 [28 days]

      Incidence of COVID-19 related hospitalization at 28 days

    2. COVID-19 related symptoms [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 [28 days]

      Change from baseline (day 1) as assessed to days 3, 7, 14, and 28

    4. Mortality [28 days]

      28-day mortality

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University at Buffalo Buffalo New York United States 14203

    Sponsors and Collaborators

    • State University of New York at Buffalo

    Investigators

    • Principal Investigator: Margarita L Dubocovich, Ph.D., University at Buffalo

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    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:
    Jul 16, 2020
    Last Update Posted:
    Mar 14, 2022
    Last Verified:
    Mar 1, 2022
    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, SUNY Distinguished Professor Dept of Pharmacology and Toxicology, State University of New York at Buffalo
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 14, 2022