Fluvoxamine for Early Treatment of Covid-19 (Stop Covid 2)

NCT04668950 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 202011101
• Study Type: interventional
• Target: 670
• Locations: 2 countries
• Sites: 5

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. People around the United States and Canada can participate.

Conditions

Covid19; Coronavirus

Keywords

fluvoxamine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinical Deterioration

  Defined as the number of participants who experienced the following: both of the following: 1)Presence of dyspnea and/or hospitalization for shortness of breath or pneumonia, 2)) decrease in O2 saturation (\<92% on room air) and/or supplemental oxygen requirement to keep O2 saturation ≥92%).

  RCT-approximately 15 days

Study Arms (2)

Fluvoxamine

EXPERIMENTAL

Start fluvoxamine 50mg capsule once, then 100mg twice daily. May reduce dose for tolerability reasons. Will be followed in the RCT for approximately 15 days.

Drug: Fluvoxamine

Placebo

PLACEBO COMPARATOR

Start placebo one capsule, twice daily. May reduce dose for tolerability reasons. Will be followed in RCT for approximately 15 days.

Drug: Placebo

Interventions

Fluvoxamine DRUG

Up to 200mg per day (2 capsules per day) as tolerated, for approximately 15 days

Also known as: Luvox

Fluvoxamine

Placebo DRUG

Will take 2 capsules per day as tolerated for approximately 15 days

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and woman age 30 and older;
• Not currently hospitalized
• Proven SARS-CoV-2 positive (per lab or physician report).
• Currently symptomatic with one or more of the following symptoms: fever, cough, myalgia, mild dyspnea, chest pain, diarrhea, nausea, vomiting, anosmia (inability to smell), ageusia (inability to taste), sore throat, nasal congestion.
• Able to provide informed consent.
• Upon initial screening, participant reports one of the following risk factors for clinical deterioration: age≥40, racial/ethnic group African-American, Hispanic, or Native American (including more than one race), or 1+ of the following medical conditions which increase risk for developing moderate-severe COVID illness: obesity, hypertension, diabetes, heart disease (coronary artery disease, history of myocardial infarction, or heart failure), lung disease (eg asthma, COPD), immune disorder (eg rheumatoid arthritis, lupus).

You may not qualify if:

• Illness severe enough to require hospitalization or already meeting study's primary endpoint for clinical worsening (eg current O2 saturation \<92% on room air, current use of supplemental oxygen to maintain O2 saturation ≥92%).
• Unstable medical comorbidities (eg decompensated cirrhosis), per patient report and/or medical records.
• Immunocompromised from the following: solid organ transplant, BMT, high dose steroids (\>20mg prednisone per day), or tocilizumab
• Already enrolled in another COVID 19 medication trial (not including vaccination or prophylaxis trials)
• Unable to provide informed consent
• Unable to perform the study procedures
• Taking donepezil (rationale: donepezil is a S1R agonist), or sertraline (rationale: sertraline is a strong sigma-1 antagonist).
• Taking warfarin-also known as Coumadin (rationale: increased risk of bleeding), phenytoin (rationale: fluvoxamine inhibits its metabolism), clopidogrel (rationale: fluvoxamine inhibits its metabolism from pro-drug to active drug which raises risk of cardiovascular events), and St John's wort (rationale: fluvoxamine + St John's wort are considered contraindicated because of the risk of serotonin syndrome)
• Taking SSRIs, SNRIs, or tricyclic antidepressants, unless these are at a low dose such that a study investigator concludes that a clinically significant interaction with fluvoxamine (ie either serotonin syndrome or TCA overdose) is unlikely (examples: participant takes escitalopram but only at 5-10mg daily; that dose plus 200mg fluvoxamine would be insufficient to cause serotonin syndrome; or, participant takes amitriptyline but only at 25mg nightly; even if fluvoxamine inhibits its metabolism, it would be an insufficient dose to cause QTc prolongation or problematic side effects).
• Individuals who report they have bipolar disorder or are taking medication for bipolar disorder (lithium, valproate, high-dose antipsychotic), unless the investigator concludes that the risk for mania is unlikely (ie it is doubtful that the patient actually has bipolar disorder).
• Individuals who take alprazolam or diazepam and are unwilling to cut the medication by 25% (rationale: fluvoxamine modestly inhibits the metabolism of these drugs).
• Participants taking theophylline, tizanidine, clozapine, or olanzapine (drugs with a narrow therapeutic index that are primarily metabolized by CYP 1A2, which is inhibited by fluvoxamine) will be reviewed with a study investigator and excluded unless the investigator concludes that the risk to the participant is low (this would be unlikely; example: participant takes tizanidine only as needed and is willing to avoid it for the 15 days of the study).
• Received vaccine for COVID-19.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Covid-19 Early Treatment Fund: collaborator
• McGill University: collaborator
• Cures Within Reach: collaborator

Study Sites (5)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Fred Hutchinson

Seattle, Washington, 98109, United States

Location

McGill University Health Center

Montreal, Quebec, H4A3S9, Canada

Location

Related Publications (1)

• Reiersen AM, Mattar C, Bender Ignacio RA, Boulware DR, Lee TC, Hess R, Lankowski AJ, McDonald EG, Miller JP, Powderly WG, Pullen MF, Rado JT, Rich MW, Schiffer JT, Schweiger J, Spivak AM, Stevens A, Vigod SN, Agarwal P, Yang L, Yingling M, Gettinger TR, Zorumski CF, Lenze EJ. The STOP COVID 2 Study: Fluvoxamine vs Placebo for Outpatients With Symptomatic COVID-19, a Fully Remote Randomized Controlled Trial. Open Forum Infect Dis. 2023 Aug 8;10(8):ofad419. doi: 10.1093/ofid/ofad419. eCollection 2023 Aug.

  PMID: 37622035 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Dr. Eric Lenze
• Organization: Washington University in St. Louis

lenzee@wustl.edu

314-362-5154

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 16, 2020
• Study Start: December 22, 2020
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: October 31, 2022
• Results First Posted: October 18, 2022

Record last verified: 2022-10

Locations

CA (1); US (4)