Supplementary material 4 to:
Fluvoxamine for the treatment of COVID-19

Nyirenda JLZ, Sofroniou M, Toews I, Mikolajewska A, Lehane C, Monsef I, Abu-taha A, Maun A, Stegemann M, Schmucker C
https://doi.org/10.1002/14651858.CD015391

Cochrane disclaims all liability and responsibility arising from any reliance placed on this supplementary material which has been supplied by the author(s). The above associated publication’s Author Licence will apply in respect of any supplemental materials published. How to cite the supplementary material is defined in the Cochrane policy.

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Characteristics of studies awaiting classification

Table of contents

Studies ordered by study ID

NCT04668950
Methods

  • Trial design: randomised, triple-blind, placebo-controlled

  • Type of record: trial register entry and published protocol

  • Sample size: 683

  • Setting: non-hospitalised, outpatients

  • Country: Canada, USA

  • Language: English

  • Number of centres: 5

  • Trial registration number: NCT04342663

  • Date of trial registration: 16 December 2020
Participants

Inclusion criteria

  • Adult (30 years and older)

  • Proven SARS-CoV-2 positive (per lab or physician report)

  • Symptomatic: fever, cough, myalgia, mild dyspnoea, chest pain, diarrhoea, nausea, vomiting, anosmia (inability to smell), ageusia (inability to taste), sore throat, nasal congestion

  • Risk factors for clinical deterioration

Exclusion criteria

  • Unstable medical comorbidities (e.g. decompensated cirrhosis), per patient report and/or medical records

  • Immunocompromised; e.g. solid organ transplant, BMT, high dose steroids (>20 mg prednisone per day), or tocilizumab

  • Already enrolled in another COVID-19 medication trial (not including vaccination or prophylaxis trials)

  • Unable to perform the study procedures

  • Taking other medications like donepezil, or sertraline, or warfarin (Coumadin), or taking SSRIs or tricyclic antidepressants at high dose, or taking alprazolam or diazepam

  • Received vaccine for COVID-19
Interventions

Details of intervention

  • Fluvoxamine 50 mg once daily, then 100 mg twice daily; up to 200 mg per day as tolerated, for approximately 15 days; reduce dose for tolerability reasons

Treatment details of control group (e.g. type, dose, route of administration)

  • Placebo one capsule, twice daily, for approximately 15 days; may reduce dose for tolerability reasons
Outcomes

Primary study outcomes

  • Clinical deterioration at 15 days defined as 1) presence of dyspnoea and/or hospitalisation for shortness of breath or pneumonia and 2) decrease in O2 saturation (< 92% on room air) and/or supplemental oxygen requirement (to keep O2 saturation ≥ 92%

Relevant study outcomes planned

  • Quality of life

Secondary outcomes

  • Post-Covid function at day 15 and day 90
Notes

  • Reason for awaiting classification: as of 13 January 2022, completed recruitment, but no results have been published

  • Recruitment status: completed

  • Prospective completion date: 28 September 2021

  • Data last update was posted: 13 January 2022

  • Sponsorship/funding source: Washington University School of Medicine
Safa 2020
Methods

  • Trial design: randomised clinical trial

  • Type of record: trial register entry and published protocol

  • Sample size: 40

  • Setting: hospitalised, inpatients

  • Country: Iran

  • Language: Persian

  • Number of centres: 1

  • Trial registration number: IRCT20131115015405N4

  • Date of trial registration: 03 October 2020 (retrospective registration)
Participants

Inclusion criteria

  • Adult (18 years and older)

  • COVID-19 patients on intensive care unit

  • Being conscious

  • Informed consent

  • Definite diagnosis of COVID-19 in medical records of the patient

Exclusion criteria

  • Being pregnant

  • Simultaneous consumption of any kind of alcohol or substance
Interventions

Details of intervention of relevant arms

  • Fluvoxamine 50 mg capsule per night (dose to be increased to 300 mg/day if tolerated)

Treatment details of control group (e.g. type, dose, route of administration)

  • Standard care
Outcomes

Primary study outcomes

  • quality of life

  • mortality
Notes

  • Reasons for awaiting classification

    • publication is in the Persian language

    • contacting the authors was not successful

    • automated translations was insufficient for a formal assessment or inclusion of the study

  • Recruitment Status: completed and results published

  • Prospective completion date: 5 September 2020

  • Date last update was posted: 6 October 2020

  • Sponsorship/funding source: Shahid Beheshti University of Medical Sciences

Footnotes

COVID-19: coronavirus disease 2019; SARS-CoV-2: Severe Acute Respiratory Syndrome Coronavirus 2; SSRIs: selective serotonin reuptake inhibitors

References to studies

NCT04668950 {unpublished data only}

Safa 2020 {published and unpublished data}