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The Effect of Melatonin and Vitamin C on 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: NCT04530539
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Lancaster General Hospital

Brief Summary:
This is a double-blind placebo controlled trial that seeks to evaluate the impact of melatonin and vitamin C on symptoms and outcomes of patients with COVID-19.

Condition or disease Intervention/treatment Phase
Covid19 SARS-CoV Infection Dietary Supplement: Vitamin C Dietary Supplement: melatonin Dietary Supplement: Placebo Other: Symptom Survey Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: The Effect of Melatonin and Vitamin C on COVID-19
Actual Study Start Date : October 5, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2021


Arm Intervention/treatment
Experimental: Experimental- Melatonin
Patients will receive melatonin
Dietary Supplement: melatonin
10mg melatonin, at bedtime

Other: Symptom Survey
Daily symptom survey to be completed by patient electronically

Experimental: Experimental- Vit C
Patients will receive vitamin C
Dietary Supplement: Vitamin C
1000mg Vitamin C, at bedtime
Other Name: ascorbic acid

Other: Symptom Survey
Daily symptom survey to be completed by patient electronically

Placebo Comparator: Control
Patients will receive placebo
Dietary Supplement: Placebo
Placebo at bedtime

Other: Symptom Survey
Daily symptom survey to be completed by patient electronically




Primary Outcome Measures :
  1. Symptom Severity [ Time Frame: 14 days ]
    Symptom severity will be tracked electronically


Secondary Outcome Measures :
  1. Symptom progression [ Time Frame: 14 days ]
    Determine symptom course of those with moderate or severe symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • COVID-19 positive test (outpatient testing),
  • Age >50 (chosen based greater risk for older patients to be vitamin deficient, age >65 not used so as not to be too restrictive in the inclusion criteria)
  • Experiencing symptoms for <5 days prior to enrollment
  • Able to read and write in English or Spanish
  • Able to access REDCap daily
  • Valid email address
  • Current has a Lancaster General Health primary care physician

Exclusion Criteria

  • COVID-19 test ordered pre-procedure for asymptomatic screening
  • Currently taking vitamin C supplements
  • Currently taking melatonin supplements
  • Currently hospitalized
  • Deceased
  • Currently pregnant
  • Currently incarcerated

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): NCT04530539


Contacts
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Contact: Tawnya Vernon 7175447395 tawnya.vernon@pennmedicine.upenn.edu
Contact: Ca Forney 7175441402 Cathleen.Forney@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Lancaster General Health Recruiting
Lancaster, Pennsylvania, United States, 17602
Contact: Tawnya Vernon    717-544-7395    Tawnya.Vernon@pennmedicine.upenn.edu   
Contact: Cathleen Forney    7175441402    Cathleen.Forney@pennmedicine.upenn.edu   
Principal Investigator: Corey Fogleman, MD         
Sub-Investigator: Donna Cohen, MD         
Sub-Investigator: Jennifer Rutz, MD         
Sub-Investigator: Daniel Farrell, MD         
Sub-Investigator: Alison Mercier, MD         
Sponsors and Collaborators
Lancaster General Hospital
Investigators
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Principal Investigator: Corey Fogleman Penn Medicine Lancaster General Health
Principal Investigator: Corey Fogleman, MD Physician
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Responsible Party: Lancaster General Hospital
ClinicalTrials.gov Identifier: NCT04530539    
Other Study ID Numbers: 2020-68
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lancaster General Hospital:
vitamin c
melatonin
Additional relevant MeSH terms:
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COVID-19
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ascorbic Acid
Melatonin
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Depressants