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

NCT04342663 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 202004023
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID 19; Coronavirus

Keywords

COVID 19; fluvoxamine

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Met Clinical Worsening

  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%.

  RCT (approximately 15 days)

Secondary Outcomes (1)

• Clinical Deterioration on a Likert-type Scale (0-6)

  RCT (approximately 15 days)

Study Arms (2)

Fluvoxamine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Fluvoxamine DRUG

Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.

Also known as: Luvox

Fluvoxamine

Placebo DRUG

Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.

Placebo

Eligibility Criteria

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

You may qualify if:

• men and woman age 18 and older;
• Not hospitalized;
• Has recently tested SARS-CoV-2 (COVID-19 virus) positive.
• 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.
• Able to provide informed consent.

You may not qualify if:

• Illness severe enough to require hospitalization or already meeting study's primary endpoint for clinical worsening.
• 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).
• Immunocompromised (solid organ transplant, BMT, AIDS, on biologics and/or high dose steroids (\>20mg prednisone per day)
• Unable to provide informed consent (eg moderate-severe dementia diagnosis)
• Unable to perform the study procedures

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

BJC

Belleville, Illinois, 62220, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020.

  PMID: 33240091 DERIVED

• Lenze EJ, Mattar C, Zorumski CF, Stevens A, Schweiger J, Nicol GE, Miller JP, Yang L, Yingling M, Avidan MS, Reiersen AM. Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial. JAMA. 2020 Dec 8;324(22):2292-2300. doi: 10.1001/jama.2020.22760.

  PMID: 33180097 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

Limitations and Caveats

It was a small study and was conducted within a single geographic area; there was a small number of end point events; it is possible that the differences in clinical deterioration may have been a reflection of the comparative baseline distributions of O2 saturation rather than an effect of treatment; the method of measuring the most severe baseline symptom over time did not appear to provide valid data; the follow-up was short; the 7-point scale created for this study has not been validated.

Results Point of Contact

• Title: Dr. Eric Lenze
• Organization: Washington University School of Medicine

lenzee@wustl.edu

314-362-5154

Study Officials

• Eric J Lenze, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wallace and Lucille Renard Professor of Psychiatry

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 13, 2020
• Study Start: April 10, 2020
• Primary Completion: August 20, 2020
• Study Completion: December 12, 2020
• Last Updated: July 9, 2021
• Results First Posted: July 9, 2021

Record last verified: 2021-07

Locations

US (2)