Trial · NCT04474483
Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19
NCT04474483, Phase 2, Terminated, State University of New York at Buffalo; results first posted 2024-02-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19. Trials, record NCT04474483. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04474483
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19
- NCT number
- NCT04474483
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- State University of New York at Buffalo
- Conditions
- COVID-19
- Interventions
- Melatonin, Placebo (Methylcellulose) capsule
- First posted
- 2020-07-16
- Last updated
- 2024-02-07
- Results first posted
- 2024-02-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Treatment-Emergent Adverse Events | 28 days | Evaluate the number of serious adverse effects and discontinuation secondary to toxicity through 28 days of follow-up as compared to the control arm as assessed by: Cumulative number of serious adverse events (SAEs), Cumulative number of Grade 3 and 4 adverse events (AEs), Discontinuation or temporary suspension of the investigational medication (for any reason). |
| Secondary | Hospitalization | 28 days | Number of COVID-19 related hospitalizations at 28 days |
| Secondary | COVID-19 Related Symptoms | 28 days | COVID-19 related symptoms (Fever, chills, cough, nasal symptoms, body aches/muscle aches, headache, loss of smell, loss of taste, nausea, vomiting, diarrhea, fatigue, dizziness) that are self-reported and on interview. |
| Secondary | Rate of Resolution of COVID-19 Related Symptoms | 28 days | We designed a COVID-19 symptom scale. Participants rated 11 COVID related symptoms on a scale of 0-5. A maximum score of 55 would indicate the worst symptoms, while a score of 0 would indicate no symptoms. Change from baseline (day 1) in the total symptoms score was assessed on days 3, 7, 14, and 28. |
| Secondary | Mortality | 28 days | 28-day mortality |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Treatment-Emergent Adverse Events | 28 days | All participants who enrolled and took at least one dose of the medication/placebo | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hospitalization | 28 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | COVID-19 Related Symptoms | 28 days | participants | NUMBER | |
| SECONDARY | Rate of Resolution of COVID-19 Related Symptoms | 28 days | 1 participant in each group was hospitalized and 1 was lost to follow up. | score on a scale | MEAN |
| SECONDARY | Mortality | 28 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Treatment-Emergent Adverse Events | Control | 0 | Participants | ||
| Number of Treatment-Emergent Adverse Events | Melatonin | 0 | Participants | ||
| Hospitalization | Control | 1 | Participants | ||
| Hospitalization | Melatonin | 1 | Participants | ||
| COVID-19 Related Symptoms | Control | 3 | participants | ||
| COVID-19 Related Symptoms | Melatonin | 5 | participants | ||
| Rate of Resolution of COVID-19 Related Symptoms | Control | baseline | 23.7 | Standard Error 6.1 | score on a scale |
| Rate of Resolution of COVID-19 Related Symptoms | Melatonin | baseline | 16.4 | Standard Error 7.7 | score on a scale |
| Rate of Resolution of COVID-19 Related Symptoms | Control | Visit 2 | 12 | Standard Error 0 | score on a scale |
| Rate of Resolution of COVID-19 Related Symptoms | Melatonin | Visit 2 | 13.7 | Standard Error 4.2 | score on a scale |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control | 3 | |
| Overall Study | STARTED | Melatonin | 5 | |
| Overall Study | COMPLETED | Control | 1 | |
| Overall Study | COMPLETED | Melatonin | 3 | |
| Overall Study | NOT COMPLETED | Control | 2 | |
| Overall Study | NOT COMPLETED | Melatonin | 2 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | hospitalization | Infections and infestations | Control | 1 | 3 | 1 |
| serious | hospitalization | Infections and infestations | Melatonin | 1 | 5 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control | 0 | 3 |
| Total, all-cause mortality | Melatonin | 0 | 5 |
| Total, other adverse events | Control | 0 | 3 |
| Total, other adverse events | Melatonin | 0 | 5 |
| Total, serious adverse events | Control | 1 | 3 |
| Total, serious adverse events | Melatonin | 1 | 5 |
Source ClinicalTrials.gov
Papers18
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Melatonin vs Control: Hospitalization | Trial comparisons |
| Melatonin vs Control: Mortality | Trial comparisons |
| Melatonin vs Control: COVID-19 Related Symptoms | Trial comparisons |
| Melatonin vs Control: deaths from any cause | Trial comparisons |
| Melatonin vs Control: Number of Treatment-Emergent Adverse Events | Trial comparisons |
| Melatonin vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04474483
GET https://conductscience.org/api/trials/v1/NCT04474483/registered