NCT04530539CompletedNot Applicable
The Effect of Melatonin and Vitamin C on COVID-19
Lancaster General Hospital1 site in 1 country122 target enrollmentStarted: October 5, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Lancaster General Hospital
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Symptom Severity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Currently pregnant
- •Currently incarcerated
Arms & Interventions
Experimental- Melatonin
Experimental
Patients will receive melatonin
Intervention: Symptom Survey (Other)
Experimental- Vit C
Experimental
Patients will receive vitamin C
Intervention: Symptom Survey (Other)
Control
Placebo Comparator
Patients will receive placebo
Intervention: Placebo (Dietary Supplement)
Control
Placebo Comparator
Patients will receive placebo
Intervention: Symptom Survey (Other)
Experimental- Vit C
Experimental
Patients will receive vitamin C
Intervention: Vitamin C (Dietary Supplement)
Experimental- Melatonin
Experimental
Patients will receive melatonin
Intervention: melatonin (Dietary Supplement)
Outcomes
Primary Outcomes
Symptom Severity
Time Frame: 14 days
Symptom severity will be tracked electronically
Secondary Outcomes
- Symptom progression(14 days)
Investigators
Study Sites (1)
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