Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784754
Status:
WITHDRAWN
Last Update Posted:
2022-07-22
First Post:
2021-02-22
Brief Title:
Dose-Ranging Study to Assess the Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19
Sponsor:
State University of New York at Buffalo
Organization:
State University of New York at Buffalo
Study Overview
Official Title:
A Pilot Placebo-controlled Randomized Double-blind Trial of Melatonin in Outpatients With COVID-19 Infection
Status:
WITHDRAWN
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of subject enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A pilot placebo-controlled randomized double-blind trial of Melatonin in outpatients with COVID-19 infection to evaluate Safety Efficacy and Dose-ranging
Detailed Description:
Studies have shown in the blood of patients with COVID-19 there was a marked increase in the cytokines and chemokines interleukin 1β IL-1β interferon-γ IFN-γ interferon-inducible protein 10 IP-10 monocyte chemoattractant protein 1 MCP-1 and interleukin-4 IL-4 Consequently treatments that reduce cytokinechemokine production that result in a less severe course of disease could be potentially beneficial Melatonin a pineal hormone has been shown to have anti-inflammation anti-oxidation and immune enhancing features In multiple animal models of lung injury Melatonin supplementation has been shown to decrease the number of inflammatory cells reduce the levels of the cytokines IL-4 IL-5 IL-13 and TNF-a and reduce nitric oxide and hydroxyl radical concentrations We propose a dose ranging pilot study to assess the safety and efficacy of melatonin in reducing hospitalization in COVID-19 patients with mild-moderate disease A total of 50 participants will be randomized to the intervention arm melatonin 3 mg or 30 mg three times a day for 14 days or control arm placebo in a 221 fashion using a permuted block randomization scheme Analyses will be performed with a focus on estimation of specific clinically important parameters including safety and preliminary evidence of activity for planning of a subsequent definitive comparative trial designed to fully assess efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1TR001412 | NIH | None | httpsreporternihgovquickSearchUL1TR001412 |