NCT04530539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2022

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

August 26, 2020

Last Update Submit

August 16, 2022

Conditions

Covid19SARS-CoV Infection

Keywords

vitamin cmelatonin

Outcome Measures

Primary Outcomes (1)

  • Symptom Severity

    Symptom severity will be tracked electronically

    14 days

Secondary Outcomes (1)

  • Symptom progression

    14 days

Study Arms (3)

Experimental- Melatonin

EXPERIMENTAL

Patients will receive melatonin

Dietary Supplement: melatoninOther: Symptom Survey

Experimental- Vit C

EXPERIMENTAL

Patients will receive vitamin C

Dietary Supplement: Vitamin COther: Symptom Survey

Control

PLACEBO COMPARATOR

Patients will receive placebo

Dietary Supplement: PlaceboOther: Symptom Survey

Interventions

Vitamin CDIETARY_SUPPLEMENT

1000mg Vitamin C, at bedtime

Also known as: ascorbic acid
Experimental- Vit C
melatoninDIETARY_SUPPLEMENT

10mg melatonin, at bedtime

Experimental- Melatonin
PlaceboDIETARY_SUPPLEMENT

Placebo at bedtime

Control
Symptom SurveyOTHER

Daily symptom survey to be completed by patient electronically

ControlExperimental- MelatoninExperimental- Vit C

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COVID-19 positive test (outpatient testing),
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lancaster General Health

Lancaster, Pennsylvania, 17602, United States

Location

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory Syndrome

Interventions

Ascorbic AcidMelatonin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesTryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Corey Fogleman

    Penn Medicine Lancaster General Health

    PRINCIPAL INVESTIGATOR

  • Corey Fogleman, MD

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2020

First Posted

August 28, 2020

Study Start

October 5, 2020

Primary Completion

August 11, 2022

Study Completion

August 11, 2022

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)