The Effect of Melatonin and Vitamin C on COVID-19 | NCT04530539

Studies
The Effect of Melatonin and Vitamin C on COVID-19

NCT04530539

Sponsor

Lancaster General Hospital

Status

Completed

Last Update Posted

Aug 17, 2022Actual

Enrollment

122Actual

Phase

Not Applicable

Conditions

Covid19
SARS-CoV Infection

Interventions

Vitamin C
melatonin
Placebo
Symptom Survey

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2020Actual

Primary Completion Date

Aug 11, 2022Actual

Completion Date

Aug 11, 2022Actual

First Submitted Date

Aug 26, 2020

First Submission Date that Met QC Criteria

Aug 26, 2020

First Posted Date

Aug 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2022

Last Update Posted Date

Aug 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental- Melatonin	Experimental	Patients will receive melatonin	Dietary Supplement: melatonin Other: Symptom Survey
Experimental- Vit C	Experimental	Patients will receive vitamin C	Dietary Supplement: Vitamin C Other: Symptom Survey
Control	Placebo Comparator	Patients will receive placebo	Dietary Supplement: Placebo Other: Symptom Survey

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin C	Dietary Supplement	1000mg Vitamin C, at bedtime	Experimental- Vit C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Symptom Severity	Symptom severity will be tracked electronically	14 days

Secondary Outcomes

Measure	Description	Time Frame
Symptom progression	Determine symptom course of those with moderate or severe symptoms	14 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Corey Fogleman	Penn Medicine Lancaster General Health	Principal Investigator
Corey Fogleman, MD	Physician	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lancaster General Health		Lancaster	Pennsylvania	17602	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D045169	Severe Acute Respiratory Syndrome

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001205	Ascorbic Acid
D008550	Melatonin

Ancestor Terms

ID	Term
D013400	Sugar Acids
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided