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A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection (STOP COVID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04342663
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Eric Lenze, Washington University School of Medicine

Brief Summary:

The purpose of this research study is to determine if a drug called fluvoxamine can be used early in the course of the COVID-19 infection to prevent more serious complications like shortness of breath. Fluvoxamine is an anti-depressant drug approved by the FDA for the treatment of obsessive-compulsive disorder. The use of fluvoxamine for the treatment of COVID-19 is considered investigational, which means the US Food and Drug Administration has not approved it for this use.

This study is fully-remote, which means that there is no face-to-face contact; study materials including study drug will be shipped to participants' houses. Only residents of Missouri and Illinois may participate.


Condition or disease Intervention/treatment Phase
COVID 19 Coronavirus Drug: Fluvoxamine Drug: Placebo Phase 2

Detailed Description:

We will consent approximately 152 participants, age 18 and older, who have tested tested positive for COVID-19 and are currently experiencing mild symptoms. All interactions for this study will be conducted remotely by videoconferencing, email, or phone.

Screening: All participants will first complete a pre-screen to see if they may be eligible for the study. Once a participant is confirmed eligible and consented, the study team will send the study materials. These materials will consist of study medication and self-monitoring equipment, including a pregnancy test (for females of childbearing age not using contraception), an oxygen saturation monitor, blood pressure monitor, and thermometer. Once the study team has finalized the screening process, the participant will begin taking the study medication.

RCT: Participants will be randomly assigned (1:1) to take either fluvoxamine or a placebo. This phase of the study will last approximately 15 days and is double-blinded. Participants will take 100mg of fluvoxamine or placebo by mouth three times a day for a daily total of 300mg. They will continue this dose for approximately 15 days. Depending on tolerability, the dose may be adjusted. Participants will also complete short 10-15 minute assessments daily to assess symptoms, results of self-monitoring (including oxygen level, blood pressure, and temperature) and any adverse events.

Open-label Phase: After completing the randomization phase, participants will then participate in an open-label phase (participant will definitely receive fluvoxamine) that will last up to 15 days. Those randomized to placebo will have the opportunity to try fluvoxamine during this time. Those randomized to fluvoxamine will continue this medication while slowly decreasing the drug. The participant may opt out of this phase. The dosage during this time will be 50-100mg two times daily until discontinuing the drug. Participants will also continue completing short 10-15 minute daily assessments to assess physical symptoms, vitals, and any adverse events.

Follow-up Phase: We will follow participants for approximately 30 days after the end of the randomized phase. During this time, they may continue to complete daily study assessments to monitor physical symptoms, vitals, and adverse events. If needed, the study team will review medical records to determine the clinical course of participants.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled Clinical Trial of Fluvoxamine for Symptomatic Individuals With COVID-19 Infection
Actual Study Start Date : April 10, 2020
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : September 1, 2020


Arm Intervention/treatment
Experimental: Fluvoxamine
Start fluvoxamine 100mg capsules, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in the RCT for approximately 15 days.
Drug: Fluvoxamine
Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.
Other Name: Luvox

Placebo Comparator: Placebo
Start placebo one capsule, three times daily. May reduce dose (or start at reduced dose) for tolerability reasons. Will be followed in RCT for approximately 15 days.
Drug: Placebo
Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.




Primary Outcome Measures :
  1. Time to clinical worsening [ Time Frame: RCT (approximately 15 days) ]
    Clinical worsening is defined meeting both of the following: (1) presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, plus (2) decrease in O2 saturation (<92%) on room air and/or supplemental oxygen requirement in order to keep O2 saturation >92%.


Secondary Outcome Measures :
  1. clinical deterioration on a Likert-type scale (1-6) [ Time Frame: RCT (approximately 15 days) ]
    (1) moderate severity of illness as defined by O2 saturation <92% but no supplemental oxygen requirement; (2) O2 saturation plus supplemental oxygen requirement; (3) O2 saturation <92% plus hospitalization (related to dyspnea/hypoxia); (4) the above, plus ventilator support requirement; (5) the above, plus ventilator support for at least 3 days; (6) death.

  2. clinical deterioration measured by number of days [ Time Frame: RCT (approximately 15 days) ]
    (1) requiring supplemental oxygen; (2) requiring hospitalization; (3) requiring ventilator support.

  3. Symptomatic severity on a likert scale (0-10 where 0= none and 10=very severe) [ Time Frame: RCT (approximately 15 days) ]
    Outcomes will be collected daily, with symptomatic data collected approximately twice daily. The most severe symptom at baseline will be the focus.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. men and woman age 18 and older;
  2. Not hospitalized;
  3. Has recently tested SARS-CoV-2 (COVID-19 virus) positive.
  4. Currently symptomatic with one or more of one or more of the following symptoms: fever, cough, myalgia, mild dyspnea, diarrhea, vomiting, anosmia (inability to smell), ageusia (inability to taste), sore throat.
  5. Able to provide informed consent.

Exclusion Criteria:

  1. Illness severe enough to require hospitalization or already meeting study's primary endpoint for clinical worsening.
  2. Unstable medical comorbidities including, but not limited to: Severe underlying lung disease (COPD on home oxygen, interstitial lung disease, pulmonary hypertension), decompensated cirrhosis, Congestive heart failure (stage 3 or 4 per patient report and/or medical records).
  3. Immunocompromised (solid organ transplant, BMT, AIDS, on biologics and/or high dose steroids (>20mg prednisone per day)
  4. Unable to provide informed consent (eg moderate-severe dementia diagnosis)
  5. Unable to perform the study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04342663


Contacts
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Contact: Angela Stevens (314)362-6291 stevens.a@wustl.edu
Contact: Marissa Rhea, MA (314)362-3797 marissa@wustl.edu

Locations
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United States, Illinois
BJC Recruiting
Belleville, Illinois, United States, 62220
Contact: Angela Stevens         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Angela Stevens         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Eric J Lenze, MD Washington University School of Medicine
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Responsible Party: Eric Lenze, Wallace and Lucille Renard Professor of Psychiatry, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04342663    
Other Study ID Numbers: 202004023
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eric Lenze, Washington University School of Medicine:
COVID 19
fluvoxamine
Additional relevant MeSH terms:
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Infection
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Fluvoxamine
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors