The Effect of Melatonin and Vitamin C on COVID-19

• ClinicalTrials.gov Identifier: NCT04530539
• Recruitment Status: Completed
• First Posted: August 28, 2020
• Last Update Posted: August 17, 2022
• Sponsor: Lancaster General Hospital
• Information provided by (Responsible Party): Lancaster General Hospital

Tracking Information

• First Submitted Date: August 26, 2020
• First Posted Date: August 28, 2020
• Last Update Posted Date: August 17, 2022
• Actual Study Start Date: October 5, 2020
• Actual Primary Completion Date: August 11, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 26, 2020)

Symptom Severity [ Time Frame: 14 days ]

Symptom severity will be tracked electronically

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 26, 2020)

Symptom progression [ Time Frame: 14 days ]

Determine symptom course of those with moderate or severe symptoms

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Melatonin and Vitamin C on COVID-19
• Official Title: The Effect of Melatonin and Vitamin C on COVID-19
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Supportive Care

Condition

• Covid19
• SARS-CoV Infection

Intervention

• Dietary Supplement: Vitamin C
  1000mg Vitamin C, at bedtime
  Other Name: ascorbic acid
• Dietary Supplement: melatonin
  10mg melatonin, at bedtime
• Dietary Supplement: Placebo
  Placebo at bedtime
• Other: Symptom Survey
  Daily symptom survey to be completed by patient electronically

Study Arms

• Experimental: Experimental- Melatonin
  Patients will receive melatonin
  Interventions:

  • Dietary Supplement: melatonin
  • Other: Symptom Survey
• Experimental: Experimental- Vit C
  Patients will receive vitamin C
  Interventions:

  • Dietary Supplement: Vitamin C
  • Other: Symptom Survey
• Placebo Comparator: Control
  Patients will receive placebo
  Interventions:

  • Dietary Supplement: Placebo
  • Other: Symptom Survey

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 13, 2021): 122
• Original Estimated Enrollment (submitted: August 26, 2020): 150
• Actual Study Completion Date: August 11, 2022
• Actual Primary Completion Date: August 11, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04530539
• Other Study ID Numbers: 2020-68
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lancaster General Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Lancaster General Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Corey Fogleman; Penn Medicine Lancaster General Health
• Principal Investigator: Corey Fogleman, MD; Physician

• PRS Account: Lancaster General Hospital
• Verification Date: August 2022