Study Summary
This trial is testing whether repurposed drugs can help relieve symptoms in people with mild to moderate COVID-19. People will either get the drugs or a placebo, and report any new or worsening symptoms. The trial is mostly remote, but some people may need in-person visits.
Eligible Conditions
- Coronavirus
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
3 Primary · 20 Secondary · Reporting Duration: Baseline, Day 7, 14, 28, 90, and 120
Day 7
Change in Quality of Life (QOL) as measured by the PROMIS-29
Difference in Quality of Life (QOL) as measured by the PROMIS-29 - anxiety domain
Difference in Quality of Life (QOL) as measured by the PROMIS-29 - depression domain
Difference in Quality of Life (QOL) as measured by the PROMIS-29 - fatigue domain
Difference in Quality of Life (QOL) as measured by the PROMIS-29 - pain domain
Difference in Quality of Life (QOL) as measured by the PROMIS-29 - physical function domain
Difference in Quality of Life (QOL) as measured by the PROMIS-29 - sleep domain
Difference in Quality of Life (QOL) as measured by the PROMIS-29 - social domain
Day 7, 14, 28
Difference in COVID Clinical Progression Scale
Up to 14 days
Cumulative difference in symptom and clinical event scale (difference in days benefit).
Difference in mean time unwell
Up to 28 days
Change in COVID Clinical Progression Scale
Composite score of hospitalizations, urgent care visits, and emergency room visits as measured by patient reports
Instances of 28 day hospitalization, urgent care, and emergency room visit, or death
Instances of 28 day mortality
Instances of hospitalization or death
Number of Symptom Resolutions as measured by patient reports
Number of deaths as measured by patient reports
Number of hospitalizations as measured by patient reports
Number of hospitalizations as measured by patient reports.
Number of symptoms as measured by patient reports
Time to mortality
Time to sustained recovery
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
13 Treatment Groups
Arm A - Ivermectin
1 of 13
Arm B - Fluvoxamine
1 of 13
Arm C - Fluticasone
1 of 13
Arm F - Montelukast
1 of 13
Arm D - Ivermectin 600
1 of 13
Arm A - Ivermectin 400
1 of 13
Arm E - Fluvoxamine 100
1 of 13
Arm A - Placebo
1 of 13
Arm D - Placebo
1 of 13
Arm F - Placebo
1 of 13
Arm B- Placebo
1 of 13
Arm C - Placebo
1 of 13
Arm E - Placebo
1 of 13
Experimental Treatment
Non-Treatment Group
15000 Total Participants · 13 Treatment Groups
Primary Treatment: Fluvoxamine · Has Placebo Group · Phase 3
Arm A - Ivermectin
Drug
Experimental Group · 1 Intervention: Ivermectin · Intervention Types: DrugArm B - Fluvoxamine
Drug
Experimental Group · 1 Intervention: Fluvoxamine · Intervention Types: DrugArm C - Fluticasone
Drug
Experimental Group · 1 Intervention: Fluticasone · Intervention Types: DrugArm F - Montelukast
Drug
Experimental Group · 1 Intervention: Montelukast · Intervention Types: DrugArm D - Ivermectin 600
Drug
Experimental Group · 1 Intervention: Ivermectin · Intervention Types: DrugArm A - Ivermectin 400
Drug
Experimental Group · 1 Intervention: Ivermectin · Intervention Types: DrugArm E - Fluvoxamine 100
Drug
Experimental Group · 1 Intervention: Fluvoxamine · Intervention Types: DrugArm A - Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherArm D - Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherArm F - Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherArm B- Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherArm C - Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherArm E - Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montelukast
2008
Completed Phase 4
~15460
Ivermectin
FDA approved
Fluvoxamine
FDA approved
Fluticasone furoate
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, day 7, 14, 28, 90, and 120
Who is running the clinical trial?
National Center for Advancing Translational Science (NCATS)NIH
99 Previous Clinical Trials
24,895 Total Patients Enrolled
Susanna Naggie, MDLead Sponsor
2 Previous Clinical Trials
3,071 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
202 Previous Clinical Trials
341,040 Total Patients Enrolled
Vanderbilt University Medical CenterOTHER
784 Previous Clinical Trials
583,840 Total Patients Enrolled
Adrian Hernandez, MDPrincipal InvestigatorDuke Clinical Research Institute
11 Previous Clinical Trials
9,977 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are currently experiencing two or more symptoms of an infection lasting less than a week. These symptoms can include fatigue, difficulty breathing, fever, cough, nausea, vomiting, diarrhea, body aches, chills, headache, sore throat, runny nose, or loss of sense of taste or smell.
Who else is applying?
What state do they live in?
| Texas | 60.0% |
| New Jersey | 20.0% |
| Indiana | 20.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Focus Clinical Research Solutions | 33.3% |
| Franciscan Health Michigan City | 33.3% |
| Texas Health Physicians Group | 33.3% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
How many prior treatments have patients received?
| 0 | 100.0% |
References
- Dodds, Michael G, Eileen B Doyle, Angela M Reiersen, Fran Brown, and Craig R Rayner. 2022. “Fluvoxamine for the Treatment of COVID-19”. The Lancet Global Health. Elsevier BV. doi:10.1016/s2214-109x(22)00006-7.
- Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group, and Susanna Naggie. 2022. “Inhaled Fluticasone for Outpatient Treatment of Covid-19: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial”. []. Cold Spring Harbor Laboratory. doi:10.1101/2022.07.12.22277548.
- Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group, and Susanna Naggie. 2022. “Ivermectin for Treatment of Mild-to-moderate COVID-19 in the Outpatient Setting: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial”. []. Cold Spring Harbor Laboratory. doi:10.1101/2022.06.10.22276252.
- Naggie S, Boulware DR, Lindsell CJ, Stewart TG, Gentile N, Collins S, McCarthy MW, Jayaweera D, Castro M, Sulkowski M, McTigue K, Thicklin F, Felker GM, Ginde AA, Bramante CT, Slandzicki AJ, Gabriel A, Shah NS, Lenert LA, Dunsmore SE, Adam SJ, DeLong A, Hanna G, Remaly A, Wilder R, Wilson S, Shenkman E, Hernandez AF; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) Study Group and Investigators. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Oct 21. doi: 10.1001/jama.2022.18590. [Epub ahead of print]
- Naggie S, Boulware DR, Lindsell CJ, Stewart TG, Gentile N, Collins S, McCarthy MW, Jayaweera D, Castro M, Sulkowski M, McTigue K, Thicklin F, Felker GM, Ginde AA, Bramante CT, Slandzicki AJ, Gabriel A, Shah NS, Lenert LA, Dunsmore SE, Adam SJ, DeLong A, Hanna G, Remaly A, Wilder R, Wilson S, Shenkman E, Hernandez AF; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) Study Group and Investigators. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Oct 25;328(16):1595-1603. doi: 10.1001/jama.2022.18590.
- Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group, Naggie S. Inhaled Fluticasone for Outpatient Treatment of Covid-19: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial. medRxiv. 2022 Aug 11:2022.07.12.22277548. doi: 10.1101/2022.07.12.22277548. Preprint.
- Dodds MG, Doyle EB, Reiersen AM, Brown F, Rayner CR. Fluvoxamine for the treatment of COVID-19. Lancet Glob Health. 2022 Mar;10(3):e332. doi: 10.1016/S2214-109X(22)00006-7. No abstract available.
- Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group, Naggie S. Ivermectin for Treatment of Mild-to-Moderate COVID-19 in the Outpatient Setting: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial. medRxiv. 2022 Aug 11:2022.06.10.22276252. doi: 10.1101/2022.06.10.22276252. Preprint.
- Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group; Naggie S. Ivermectin for Treatment of Mild-to-Moderate COVID-19 in the Outpatient Setting: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial. medRxiv. 2022 Aug 11:2022.06.10.22276252. doi: 10.1101/2022.06.10.22276252. Preprint.
- Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group; Naggie S. Inhaled Fluticasone for Outpatient Treatment of Covid-19: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial. medRxiv. 2022 Aug 11:2022.07.12.22277548. doi: 10.1101/2022.07.12.22277548. Preprint.
- Naggie S, Boulware DR, Lindsell CJ, Stewart TG, Gentile N, Collins S, McCarthy MW, Jayaweera D, Castro M, Sulkowski M, McTigue K, Thicklin F, Felker GM, Ginde AA, Bramante CT, Slandzicki AJ, Gabriel A, Shah NS, Lenert LA, Dunsmore SE, Adam SJ, DeLong A, Hanna G, Remaly A, Wilder R, Wilson S, Shenkman E, Hernandez AF; Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-6) Study Group and Investigators. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Oct 25;328(16):1595-1603. doi: 10.1001/jama.2022.18590. Erratum In: JAMA. 2023 Jan 10;329(2):178.
- Susanna Naggie, MD 2021. "ACTIV-6: COVID-19 Study of Repurposed Medications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04885530.
Frequently Asked Questions
What does Fluvoxamine commonly help with?
"Fluvoxamine is often given to patients suffering from strongyloidiasis, which is caused by strongyloides stercoralis infection. In addition, Fluvoxamine can help treat other conditions such as obsessive-compulsive disorder, sinusitis, and seasonal allergic rhinitis." - Anonymous Online Contributor
Unverified Answer
Where are the patients being drawn from for this trial?
"There are 94 clinical trial sites participating in this study, including but not limited to: Highlands Medical Associates, P.A. in Highlands, Texas, Health Quality Primary Care in Lawrence, Massachusetts, and Olivo Wellness Medical Center in Chicago, Illinois." - Anonymous Online Contributor
Unverified Answer
Does fluvoxamine have a history of being studied?
"Fluvoxamine was first studied in 2016 at Milton Keynes University Hospital. So far, there have been 18474 completed studies. 29 trials are still recruiting, many of which are based in Highlands, Texas." - Anonymous Online Contributor
Unverified Answer
Does Fluvoxamine have a high potential for abuse?
"Fluvoxamine's safety is well-documented, as it has gone through Phase 3 clinical trials. These trials not only test for efficacy, but also repeat testing to confirm safety." - Anonymous Online Contributor
Unverified Answer
Are we currently able to enroll in this trial?
"That is correct, the online information from clinicaltrials.gov does show that the trial is still looking for participants. The 15000 patients needed for the study are being recruited from 94 different locations, and the trial was first posted on June 8th, 2021." - Anonymous Online Contributor
Unverified Answer