Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fluvoxamine Administration in Moderate SARS-CoV-2 (COVID-19) Infected Patients

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: NCT04718480
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
SigmaDrugs Research Ltd.

Brief Summary:
This is a randomized, double-blind, placebo-controlled, adaptive two-stage design, human phase 2 study, with add-on treatment arrangement of fluvoxamine or placebo on top of standard of care (base therapy: the actual proposed therapy of moderate SARS-CoV-2 infected patients according to "Hungarian Coronavirus Handbook", including antiviral and immunmodulant therapy and reconvalescent plasma therapy in serious cases as indicated by the investigator).

Condition or disease Intervention/treatment Phase
Covid19 Drug: Placebo Drug: Fluvoxamine Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, adaptive design add-on treatment study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind, placebo-controlled,
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Adaptive-design Study to Assess the Safety and Efficacy of Daily 200 mg Fluvoxamine as add-on Therapy to Standard of Care in Moderate Severity COVID-19 Patients
Actual Study Start Date : November 27, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
2 x 100 mg placebo daily po. (with careful dose escalation and tapered dose reduction). Overall treatment period is 74 days.
Drug: Placebo
po placebo tablets

Experimental: Fluvoxamine
2 x 100 mg fluvoxamine daily po. (with careful dose escalation and tapered dose reduction). Overall treatment period is 74 days.
Drug: Fluvoxamine
po fluvoxamine tablets




Primary Outcome Measures :
  1. Time to clinical recovery after treatment [ Time Frame: 74 days ]

    days from randomization (Day 1) to ANY THREE items of the following four:

    1. resolution from fever (oral or tympanic temperature ≤ 37.5 °C, axillary ≤ 37.0 °C for at least 48 hours without antipyretics)
    2. return of respiratory rate to normal (≤ 20 / min)
    3. normalization of SpO2 ( ≥95% on room air )
    4. cough remission (any reduction in cough-burden Visual Analogue Scale, compared to Day 1 baseline)



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 18-70 years of age at screening
  • Hospitalized patients with confirmed SARS-CoV-2 by PCR or known contact of confirmed case with syndrome consistent with coronavirus disease (COVID-19) with PCR pending (positive PCR result should be available prior to randomisation).
  • Moderate cases (each of the followings met): showing dyspnoea but not manifest respiratory distress, respiratory rate 22-29 / min; oxygen saturation at rest > 93%; with or without the need for oxygen supplementation; pneumonia on medical imaging with pulmonary infiltrates occupying ≤ 50% of the lung-fields
  • Subjects who are able to communicate with the Investigator and research staff, who understand the study, are able to comply with all study procedures, and willing to provide written informed consent prior to the screening examinations.

Exclusion Criteria:

  • Mild COVID-19 at randomisation (each of the followings met): no dyspnoea, respiratory rate < 22 / min, no need for oxygen supplementation, no pneumonia on medical imaging

    • Severe COVID-19 at randomisation: respiratory distress - respiratory rate ≥ 30/min, oxygen saturation at rest ≤ 93%, pulmonary infiltrates occupy > 50% of the lung-fields
    • Critical COVID-19 at randomisation: acute respiratory distress, requiring mechanical ventilation, radiomorphology of ARDS, shock, including septic shock, other organ dysfunction necessitating ICU admission
    • High-risk patient for progression of COVID-19, as defined by having a calculated pneumonia PORT-score of > 90
    • Concomitant or previous administration of any experimental, non-established COVID-19 therapy, either in off-label indication (of a registered medicinal product) or as a non-registered drug candidate in a clinical trial setting or compassionate use program (or equivalents thereof), EXCEPT therapies recommended by the "Magyar Koronavírus Kézikönyv" (Hungarian Coronavirus Manual), and as such, are considered as standard-of-care. Concomitant use of LMWHs can be considered as emerging standard-of-care, and therefore their application is not prohibited.
    • Standard of care treatment planned with chloroquine or hydroxychloroquine.
    • Any clinically significant abnormality identified during pre-study full physical examination, vital signs, laboratory tests and ECG which is deemed by the Investigator to be incompatible / inappropriate for study participation.
    • Known hepatitis B, C, or HIV infection.
    • A current or recent history of drug or substance abuse, including alcohol (> 14 units per week), within 3 months prior to screening (one unit of alcohol equals ½ pint [285 mL] of beer or lager, one glass [125 mL] of wine, or one shot [25 mL] of spirits)
    • Patients who regularly consume more than 4 cups daily of beverage containing caffeine
    • Current strong smoker as defined by smoking over 10 cigarettes a day, or its equivalent
    • Positive pregnancy test result for women with childbearing potential at screening
    • Women who are pregnant or nursing, or who are planning to get pregnant within 3 months after the last dose of study drug
    • A history of allergy, intolerance or sensitivity to fluvoxamine or any component of the study drug formulation
    • Closed-angle glaucoma
    • Patients who are assessed as at risk for suicidal intent during screening by psychiatric evaluation (including C-SSRS questionnaire). A score of 15 or higher on the PHQ-9 depression scale at screening.
    • Have undergone surgery or have donated blood within 12 weeks prior to the start of the study
    • A history of bleeding diathesis or other bleeding disorders
    • Participated in any clinical trial involving an investigational drug or investigational device within 1 month preceding study entry, or within 5 terminal half-life of the investigational drug of this previous study
    • A history of or present malignancy, with the exception of resected basal cell carcinoma or squamous cell carcinoma of the skin, or resected cervical intraepithelial neoplasia.

Prohibited concomitant medications:

  • Co-administration of fluvoxamine with monoamine oxidase inhibitors (MAOI), including methylene blue (intravenous dye) and linezolid (an antibiotic which is a reversible non-selective MAOI)
  • Co-administration of thioridazine, mesoridazine, pimozide, terfenadine, astemizole, or cisapride with fluvoxamine; each of these drugs alone produces prolongation of the QTc interval, which is associated with serious ventricular arrhythmias, such as torsade de pointes-type arrhythmias and sudden death
  • Co-administration of tizanidine and fluvoxamine
  • Co-administration of fluvoxamine with ramelteon
  • Co-administration of fluvoxamine with chloroquine or hydroxychloroquine
  • Co-administration of morphine, or other opioids.

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): NCT04718480


Contacts
Layout table for location contacts
Contact: Andrea Fekete, PhD 0036309472333 andrea.fekete@sigmadrugs.com
Contact: Dóra FAZEKAS, Dr +36707010091 dora.fazekas@cortexps.hu

Locations
Layout table for location information
Hungary
Dél-pesti Centrumkórház Recruiting
Budapest, Hungary, 1097
Principal Investigator: János Szlávik, MD         
Semmelweis Egyetem Pulmonológiai Klinika Recruiting
Budapest, Hungary, H-1083
Principal Investigator: Veronika Müller, Prof         
Országos Korányi Pulmonológiai Intézet Recruiting
Budapest, Hungary, H-1121
Principal Investigator: János Varga, MD         
Principal Investigator: Krisztina Tóth, MD         
Debreceni Egyetem Kenézy Gyula Kórház Infektológia Recruiting
Debrecen, Hungary, 4032
Principal Investigator: István Várkonyi, MD         
Sponsors and Collaborators
SigmaDrugs Research Ltd.
Layout table for additonal information
Responsible Party: SigmaDrugs Research Ltd.
ClinicalTrials.gov Identifier: NCT04718480    
Other Study ID Numbers: SD-COVID19-01
2020-002299-11 ( EudraCT Number )
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study results will be published at the end of the study.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by SigmaDrugs Research Ltd.:
moderate COVID-19; fluvoxamine
Additional relevant MeSH terms:
Layout table for MeSH terms
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