A Phase 3 interventional study of Fluvoxamine and Placebo in Covid19, sponsored by Susanna Naggie, MD. Completed at 91 sites in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.
Sponsored by Susanna Naggie, MD · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the effectiveness of repurposed medications (study drug(s) in reducing symptoms of non-hospitalized participants with mild to moderate COVID-19. Participants will receive either study drug or placebo. They will self-report any new or worsening symptoms or medical events they may experience while taking study drug or placebo. This study is intended to be all remote with no in person visits, unless the study team feels it is in the best interest of a participant to see them in person.
Prior and current drug arms are listed on clinicaltrials.gov and will be updated with the activation of any new drug arms. Each study arm will also have its own clinicaltrials.gov entry and will include "Pro00107921" in the Unique Protocol ID.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. The clinical disease related to SARS-CoV-2 is referred to as Coronavirus Disease 2019 (COVID-19). Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the treatment of COVID-19 infection in the outpatient setting.
This proposed platform protocol can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19. The ultimate goal is to evaluate if repurposed medications can make participants feel better faster and reduce death and hospitalization.
This platform protocol is designed to be flexible so that it is suitable for a wide range of settings within healthcare systems and in community settings where it can be integrated into routine COVID-19 testing programs and subsequent treatment plans. This platform protocol will enroll participants in an outpatient setting with a confirmed polymerase chain reaction (PCR) or antigen test for SARS-CoV-2.
Participants will be randomized to study drugs or placebo based on the arms that are actively enrolling at the time of randomization. Study drugs may be added or removed according to adaptive design and/or emerging evidence. When there are multiple study drugs available, randomization will occur based on appropriateness of each drug for the participant as determined by the study protocol and investigator and participant equipoise. Each participant will be required to randomize to at least one study drug versus placebo. The probability of placebo to treatment will remain the same regardless of eligibility decisions.
Eligible participants will be randomized (1:1), in a blinded fashion, to either the study drug arm or placebo arm in addition to standard of care. As additional study drugs are added, the randomization will be altered to leverage placebo data across arms. Participants will receive a complete supply study drug or placebo with the quantity depending on the study drug/placebo to which they are randomized.
All study visits are designed to be remote. However, screening and enrollment may occur in-person at sites and unplanned study visits may occur in-person or remotely, as deemed appropriate by the site investigator for safety purposes. Participants will be asked to complete questionnaires and report safety events during the study. Participants will be prompted by the online system to report safety events and these will be reviewed and confirmed via medical records and site staff, as necessary.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 1,331 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Susanna Naggie, MD is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fluvoxamine will be self-administered orally by each participant at a dose of 50 mg twice a day for 10 days.
Drug: Fluvoxamine
Placebo - appearance and size matched to active study drug. Placebo will be self-administered orally by each participant twice a day for 10 days.
Other: Placebo
Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has "APO" and the other side has "F50" with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days.
Also known as: Fluvoxamine Maleate Tablets
Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
Time to Sustained Recovery in Days
Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.
Time frame: Up to 28 days
Number of Participants With Hospitalization or Death
Time frame: Up to 28 days
Number of Participants With Mortality
Time frame: Up to 28 days
Time to Mortality
Time to mortality was the number of days between drug receipt and death.
Time frame: Up to 28 days
Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death
Time frame: Up to 28 days
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 7
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Time frame: Day 7
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 14
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Time frame: Day 14
Number of Participants at Each Score on the COVID Clinical Progression Scale at Day 28
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
Time frame: Day 28
Quality of Life (QOL) as Measured by the PROMIS-29 - Physical Function
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function. Day 90 data to be reported by September 4, 2023.
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Fatigue
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue. Day 90 data to be reported by September 4, 2023.
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Pain
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain. Day 90 data to be reported by September 4, 2023.
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Depression
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression. Day 90 data to be reported by September 4, 2023.
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Anxiety
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Social
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities. Day 90 data to be reported by September 4, 2023.
Time frame: Day 7, 14, 28, and 90
Quality of Life (QOL) as Measured by the PROMIS-29 - Sleep
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep. Day 90 data to be reported by September 4, 2023.
Time frame: Day 7, 14, 28, and 90
Time Unwell in Days as Measured by the Symptom and Clinical Event Scale
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.
Time frame: Up to 14 days
Mean Days Benefit as Measured by the Symptom and Clinical Event Scale
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.
Time frame: Up to 14 days
| Milestone | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Started | 686 | 645 |
| Completed | 676 | 615 |
| Not completed | 10 | 30 |
Time to sustained recovery was the number of days between receipt of study drug and the third of 3 consecutive days without symptoms. Participants who died, by definition, did not recover regardless of reported symptom freedom. The reported summary is the median survival time.
| days | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Time to Sustained Recovery in Days | 12 (11 to 14) | 13 (12 to 13) |
| Participants | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Number of Participants With Hospitalization or Death | 1 | 3 |
| Participants | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Number of Participants With Mortality | 0 | 0 |
Time to mortality was the number of days between drug receipt and death.
| days | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Time to Mortality | NA (NA to NA) | NA (NA to NA) |
| Participants | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Number of Participants With Hospitalization, Urgent Care, Emergency Room Visit, or Death | 27 | 26 |
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
| Participants | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| 0 = No clinical or virological evidence of infection | 55 | 34 |
| 1 = No limitation of activities | 542 | 511 |
| 2 = Limitation of activities | 45 | 33 |
| 3 = Hospitalized, no oxygen therapy | 0 | 1 |
| 4 = Hospitalized, on oxygen by mask or nasal prongs | 0 | 1 |
| 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen | 0 | 0 |
| 6 = Hospitalized, on intubation and mechanical ventilation | 0 | 0 |
| 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO) | 0 | 0 |
| 8 = Death | 0 | 0 |
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
| Participants | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| 0 = No clinical or virological evidence of infection | 39 | 37 |
| 1 = No limitation of activities | 574 | 518 |
| 2 = Limitation of activities | 23 | 21 |
| 3 = Hospitalized, no oxygen therapy | 0 | 0 |
| 4 = Hospitalized, on oxygen by mask or nasal prongs | 0 | 0 |
| 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen | 0 | 0 |
| 6 = Hospitalized, on intubation and mechanical ventilation | 0 | 0 |
| 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO) | 0 | 0 |
| 8 = Death | 0 | 0 |
COVID Clinical Progression Scale is a scale of 0 to 8 where 0 = No clinical or virological evidence of infection, 1 = No limitation of activities, 2 = Limitation of activities, 3 = Hospitalized, no oxygen therapy, 4 = Hospitalized, on oxygen by mask or nasal prongs, 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen, 6 = Hospitalized, on intubation and mechanical ventilation, 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO), 8 = Death.
| Participants | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| 0 = No clinical or virological evidence of infection | 40 | 30 |
| 1 = No limitation of activities | 569 | 528 |
| 2 = Limitation of activities | 21 | 12 |
| 3 = Hospitalized, no oxygen therapy | 0 | 0 |
| 4 = Hospitalized, on oxygen by mask or nasal prongs | 0 | 0 |
| 5 = Hospitalized, on non-invasive ventilation or high-flow oxygen | 0 | 0 |
| 6 = Hospitalized, on intubation and mechanical ventilation | 0 | 0 |
| 7 = Hospitalized, on ventilation + additional organ support (pressors, RRT, ECMO) | 0 | 0 |
| 8 = Death | 0 | 0 |
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a higher score correlates to better outcome for physical function. Day 90 data to be reported by September 4, 2023.
| score on a scale | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Day 7 | 20 (16 to 20) | 20 (17 to 20) |
| Day 14 | 20 (19 to 20) | 20 (19 to 20) |
| Day 28 | 20 (20 to 20) | 20 (20 to 20) |
| Day 90 | 20 (20 to 20) | 20 (20 to 20) |
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for fatigue. Day 90 data to be reported by September 4, 2023.
| score on a scale | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Day 7 | 8 (7 to 12) | 8 (7 to 12) |
| Day 14 | 7 (4 to 9) | 7 (4 to 8) |
| Day 28 | 4.5 (4 to 8) | 4 (4 to 8) |
| Day 90 | 4 (4 to 8) | 4 (4 to 7) |
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for pain. Day 90 data to be reported by September 4, 2023.
| score on a scale | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Day 7 | 4 (4 to 8) | 4 (4 to 8) |
| Day 14 | 4 (4 to 6) | 4 (4 to 5) |
| Day 28 | 4 (4 to 4) | 4 (4 to 4) |
| Day 90 | 4 (4 to 4) | 4 (4 to 4) |
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20, where a lower score correlates to better outcome for depression. Day 90 data to be reported by September 4, 2023.
| score on a scale | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Day 7 | 4 (4 to 6) | 4 (4 to 6) |
| Day 14 | 4 (4 to 5) | 4 (4 to 5) |
| Day 28 | 4 (4 to 4) | 4 (4 to 5) |
| Day 90 | 4 (4 to 4) | 4 (4 to 5) |
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for anxiety.
| score on a scale | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Day 7 | 5 (4 to 7) | 5 (4 to 8) |
| Day 14 | 4 (4 to 6) | 4 (4 to 6) |
| Day 28 | 4 (4 to 5) | 4 (4 to 5) |
| Day 90 | 4 (4 to 5) | 4 (4 to 5) |
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a higher score correlates to better outcome for social roles and activities. Day 90 data to be reported by September 4, 2023.
| score on a scale | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Day 7 | 16.5 (14 to 20) | 18 (14 to 20) |
| Day 14 | 20 (16 to 20) | 20 (16 to 20) |
| Day 28 | 20 (18 to 20) | 20 (18 to 20) |
| Day 90 | 20 (19 to 20) | 20 (19 to 20) |
The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) consists of seven health domains with four 5-level items associated with each and a pain intensity assessment using a 0-10 numeric rank. The seven health domains include physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance. Raw score ranges from 4-20 where a lower score correlates to better outcome for sleep. Day 90 data to be reported by September 4, 2023.
| score on a scale | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Day 7 | 10 (8 to 12) | 10 (7 to 12) |
| Day 14 | 9 (6 to 12) | 9 (6 to 11) |
| Day 28 | 8 (6 to 11) | 8 (6 to 11) |
| Day 90 | 8 (6 to 11) | 8 (6 to 10) |
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). Time unwell was the portion of follow-up (in days) that a participant was symptomatic, hospitalized, or deceased. The quantity is estimated from a Bayesian longitudinal ordinal regression model with covariate adjustment and weakly informative priors.
| days | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Time Unwell in Days as Measured by the Symptom and Clinical Event Scale | 11.21 (11.03 to 11.42) | 11.28 (11.10 to 11.48) |
The symptom and clinical event scale is a daily measurement that combines the global symptom burden scale with clinical events hospitalization and mortality. (No symptoms, mild symptoms, moderate symptoms, severe symptoms, hospitalized, deceased). The cumulative benefit of treatment A is the probability of experiencing a better outcome on treatment A compared to treatment B, summed over the days of follow-up. The difference between the cumulative benefit of treatment A and the cumulative benefit of treatment B is known as the difference in days benefit. Measure of dispersion is 95% credible interval.
| days | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| Mean Days Benefit as Measured by the Symptom and Clinical Event Scale | 3.45 (3.23 to 3.70) | 3.37 (3.14 to 3.60) |
Collected over Up to 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm B - Fluvoxamine 50 | 0/676 (0%) | 3/676 (0.4%) | 0/676 (0%) |
| Arm B - Placebo | 0/615 (0%) | 6/615 (1%) | 0/615 (0%) |
| Event | Arm B - Fluvoxamine 50 | Arm B - Placebo |
|---|---|---|
| COPD exacerbationRespiratory, thoracic and mediastinal disorders | 2/676 | 0/615 |
| COVID-19 pneumoniaInfections and infestations | 0/676 | 1/615 |
| Coronary vasospasmVascular disorders | 0/676 | 1/615 |
| Diabetes mellitusMetabolism and nutrition disorders | 0/676 | 1/615 |
| Ophthalmic migraineEye disorders | 0/676 | 1/615 |
| Broken ankleInjury, poisoning and procedural complications | 0/676 | 1/615 |
| Chest painGeneral disorders | 0/676 | 1/615 |
| Infected fingerInfections and infestations | 1/676 | 0/615 |
Participants with Baseline Characteristics data collected.
| Age, Continuous(years) | Arm B - Fluvoxamine 50 | Arm B - Placebo | Total |
|---|---|---|---|
| Median | 47 (38 to 57) | 47 (39 to 58) | 47 (38 to 57) |
| Sex/Gender, Customized(Participants) | Arm B - Fluvoxamine 50 | Arm B - Placebo | Total |
|---|---|---|---|
| Sex/Gender — Female | 372 | 327 | 699 |
| Sex/Gender — Male | 273 | 254 | 527 |
| Sex/Gender — Prefer Not to Answer the Question | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Arm B - Fluvoxamine 50 | Arm B - Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 113 | 93 | 206 |
| Not Hispanic or Latino | 533 | 490 | 1023 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Arm B - Fluvoxamine 50 | Arm B - Placebo | Total |
|---|---|---|---|
| Race — American Indian or Alaska Native | 0 | 4 | 4 |
| Race — Asian | 39 | 33 | 72 |
| Race — Black, African American, or African | 39 | 43 | 82 |
| Race — Middle Eastern or North African | 2 | 3 | 5 |
| Race — Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Race — White | 508 | 462 | 970 |
| Race — More than one race | 16 | 9 | 25 |
| Race — None of the above | 26 | 15 | 41 |
| Race — Prefer not to answer | 9 | 10 | 19 |
| Race — No response | 7 | 3 | 10 |
| Region of Enrollment(Participants) | Arm B - Fluvoxamine 50 | Arm B - Placebo | Total |
|---|---|---|---|
| United States | 646 | 583 | 1229 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — We will share this data after it has been de-identified. We will share data beginning around 6 months after publication and for up to 36 months afterward. Access will only be shared with those who have obtained prior IRB approval to be able to access this data.
Supporting information: Sap, Csr
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Susanna Naggie, MD