Characteristics of ongoing studies

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Studies ordered by study ID

NCT04510194
Study name	COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19)
Methods	Trial design: randomised, triple-blinded Type of record: trial register entry and published protocol Sample size: 1350 Setting: outpatients Country: Canada, USA Language: English Number of centres: 5 Trial registration number: NCT04510194 Date of trial registration: 12 August 2020
Participants	Inclusion Criteria Both male and female aged 30 years to 85 years Positive laboratory test for active SARS-CoV-2 viral infection based on local laboratory standard (PCR) No known history of confirmed SARS-CoV-2 infection Electronic device for communication Exclusion Criteria Hospitalised, for COVID-19 or other reasons History of severe kidney disease Unstable heart failure
Interventions	Details of intervention Eligible patients shall be randomised to receive one of the antibiotics/combinations. metformin only fluvoxamine only ivermectin only metformin + fluvoxamine metformin + ivermectin Route of administration: oral Treatment details of control group (e.g. dose, route of administration) Placebo
Outcomes	Primary study outcomes clinical progression at 14 days; defined as emergency department visit for any COVID-19 related symptom (including hospitalisation or death) or decrease in O2 saturation (≤ 93% on room air, or need for supplemental oxygen to maintain an O2 saturation > 93%) Relevant review outcomes planned quality of life hospitalisation or death Secondary outcome maximum symptom severity at 14 days and 28 days clinical progression at 14 days and 28 days time to meaningful recovery at 14 days and 28 days
Starting date	1 January 2021
Contact information	covidout@umn.edu
Notes	Recruitment status: recruiting Prospective completion date: February 2023 Date last update was posted: 16 January 2022 Sponsorship/funding source: University of Minnesota

NCT04718480
Study name	Fluvoxamine Administration in Moderate SARS-CoV-2 (COVID-19) Infected Patients
Methods	Trial design: randomised, double-blind, placebo-controlled, adaptive-design Type of record: trial register entry and published protocol Sample size: 100 Setting: hospitalised, inpatients Country: Hungary Language: English Number of centres: 4 Trial registration number: NCT04718480 Date of trial registration: 22 January 2021
Participants	Inclusion criteria Adults (18 to 70 years) Hospitalised patients with confirmed SARS-CoV-2 by PCR Exclusion criteria Mild, severe or critical COVID-19 at randomisation Standard care treatment planned with chloroquine or hydroxychloroquine History of bleeding diathesis or other bleeding disorders, or present malignancy
Interventions	Details of intervention 2 x 100 mg fluvoxamine daily (with careful dose escalation and tapered dose reduction) Overall treatment period: 74 days Route of administration: oral Treatment details of control group (e.g. dose, route of administration) 2 x 100 mg placebo daily (with careful dose escalation and tapered dose reduction) Overall treatment period: 74 days Standard care
Outcomes	Primary study outcomes time to clinical recovery after treatment at 74 days resolution from fever return of respiratory rate to normal (≤ 20 per min) cough remission Relevant review outcomes planned clinical status quality of life Secondary outcomes maximum symptom severity at 14 and 28 days clinical progression at 14 and 28 days time to meaningful recovery at 14 and 28 days
Starting date	18 January 2021
Contact information	andrea.fekete@sigmadrugs.com
Notes	Recruitment Status: recruiting Prospective completion date: August 2022 Date last update was posted: 27 September 2021 Sponsorship/funding source: Sigma Drugs Research Ltd

NCT04885530
Study name	ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications
Methods	Trial design: randomised, double-blind, placebo-controlled Type of record: trial register entry and published protocol Sample size: 15000 Setting: non-hospitalised, outpatients Country: USA Language: English Number of centres: 74 Trial registration number: NCT04885530 Date of trial registration: 13 May 2021
Participants	Inclusion criteria Adults aged ≥ 30 years old PCR confirmed SARS-CoV-2 infection or antigen test collected within 10 days of screening Two or more current symptoms of acute infection for ≤ 7 days Exclusion criteria Prior diagnosis of COVID-19 infection Current or recent hospitalisation Known allergy/sensitivity or any hypersensitivity to components of the study drug or placebo Known contraindications to study drugs, including prohibited concomitant medications
Interventions	Details of intervention Eligible patients shall be randomised to receive one of 3 antibiotics: ivermectin (7 mg): prespecified number of tablets for 3 consecutive days based on weight for a daily dose of approximately 300 to 400 µg per kg fluvoxamine: 50 mg twice a day for 10 days fluticasone: 200 µg (1 blister) once daily for 14 days Route of administration: oral Treatment details of control group (e.g. dose, route of administration) Placebo doses matched to respective study drug
Outcomes	Primary study outcomes number of hospitalisations at 14 days number of deaths at 14 days number of symptoms at 14 days Relevant review outcomes planned clinical status quality of life symptom resolution hospitalisation Secondary outcome number of deaths at 28 days number of symptom resolution at 28 days change in quality of life composite score of hospitalisations, urgent care visits, and emergency room visits at 28 days
Starting date	13 May 2021
Contact information	sybil.wilson@duke.edu, and april.ray@duke.edu
Notes	Recruitment Status: recruiting Prospective completion date: December 2022 Date last update was posted: 13 May 2021 Sponsorship/funding source: Susanna Naggie, MD

NCT05087381
Study name	Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community
Methods	Trial design: randomised, open-label Type of record: trial register entry and published protocol Sample size: 15000 Setting: non-hospitalised, outpatients Country: Thailand Language: English Number of centres: 2 Trial registration number: NCT05087381 Date of trial registration: 21 October 2021
Participants	Inclusion criteria Adults 18 years or older Antigen Test Kit or PCR for SARS-CoV-2 positive patients with mild symptoms Exclusion criteria Recovered (generally much improved and symptoms now mild or almost absent) Clinician deems ineligible Pregnancy and breastfeeding
Interventions	Details of intervention Fluvoxamine Fluvoxamine + bromhexine Fluvoxamine + cyproheptadine Route of administration: oral Treatment details of control group (e.g. dose, route of administration) Standard care
Outcomes	Primary outcomes hospital admission related to COVID-19 at 28 days time taken to self-report recovery progression to severe COVID-19 mortality Relevant review outcomes planned: clinical worsening quality of life symptom resolution hospitalisation mortality Secondary outcomes change in respiratory viral clearance at 0, 7, 14 days time to resolution of fever
Starting date	21 October 2021
Contact information	Dhammika.L@chula.ac.th, Phatthranit.pha@mahidol.edu
Notes	Recruitment Status: recruiting Prospective completion date: March 2022 Date last update was posted: 26 January 2022 Sponsorship/funding source: Chulalongkorn University

TCTR20210615002
Study name	Effect of Combined Fluvoxamine with Favipiravir versus Favipiravir Monotherapy in Prevention of Clinical Deterioration among mild to moderate COVID-19 patients Monitoring by Telemedicine in Virtual Clinic
Methods	Trial design: randomised, open-label Type of record: trial register entry and published protocol Sample size: 296 Setting: outpatients Country: Thailand Language: English Number of centres: 2 Trial registration number: TCTR20210615002 Date of trial registration: 14 June 2021
Participants	Inclusion criteria Thai people aged 18 years or over Confirmed COVID-19 Asymptomatic COVID-19 Nasopharyngeal swab or oropharyngeal swab Exclusion criteria Respiratory tract symptoms compatible with a bacterial infection Previous receiving anti-SARS-CoV-2 agents Complete coronavirus vaccination History of favipiravir or fluvoxamine allergy Need oxygen therapy Previous use of immunosuppressive agents, a corticosteroid, azathioprine, mycophenolate mofetil, cyclosporin, JAK inhibitor Cannot home quarantine Unable to receive enteral nutrition Pregnancy or breastfeeding Terminal illness, heart failure, end-stage renal disease Taking the antibiotics, anti-inflammatory drugs, or herb within 48 hours Depression or suicidal idea Glaucoma Receiving chemotherapy Organ transplantation Evidence of any respiratory viral infection other than coronavirus
Interventions	Details of intervention Fluvoxamine + favipiravir: favipiravir 3600 mg in the initial day, then 1600 mg per day for 4 days, and fluvoxamine 100 mg per day for 10 days Favipiravir: 3600 mg in the initial day then 1600 mg per day for 4 days Fluvoxamine + favipiravir + dexamethasone: favipiravir 3600 mg in the initial day, then 1600 mg per day for 9 days, fluvoxamine 100 mg per day and dexamethasone 6 mg per day orally for 10 days Favipiravir + dexamethasone: favipiravir 3600 mg in the initial day, then 1600 mg per day for 9 days, and dexamethasone 6 mg per day orally for 10 days Route of administration: oral Treatment details of control group (e.g. dose, route of administration) Standard care
Outcomes	Primary outcome clinical deterioration in moderate COVID-19 clinical deterioration in moderate COVID-19 (pneumonia) Relevant review outcomes planned clinical worsening quality of life symptom resolution hospitalisation mortality adverse events (any grade) viral clearance Secondary outcomes duration from initial treatment to clinical deterioration changing of inflammatory marker at 0, 2, 5, 14 days adverse events at any time
Starting date	16 June 2021
Contact information	taweegrit.sir@pccms.ac.th.
Notes	Recruitment status: pending Prospective completion date: none Date last update was posted: 15 June 2021 Sponsorship/funding source: Chulabhorn Royal Academy

Footnotes

COVID-19: Coronavirus Disease 2019; JAK: Janus Kinase; PCR: Polymerase Chain Reaction; SARS-CoV-2: Severe Acute Respiratory Syndrome Coronavirus 2

Supplementary material 5 to:
Fluvoxamine for the treatment of COVID-19

Characteristics of ongoing studies

Table of contents

Studies ordered by study ID

Footnotes

References to studies

NCT04510194 {unpublished data only}

NCT04718480 {unpublished data only}

NCT04885530 {unpublished data only}

NCT05087381 {unpublished data only}

TCTR20210615002 {unpublished data only}

Supplementary material 5 to:Fluvoxamine for the treatment of COVID-19

Characteristics of ongoing studies

Table of contents

Studies ordered by study ID

Footnotes

References to studies

NCT04510194 {unpublished data only}

NCT04718480 {unpublished data only}

NCT04885530 {unpublished data only}

NCT05087381 {unpublished data only}

TCTR20210615002 {unpublished data only}

Supplementary material 5 to:
Fluvoxamine for the treatment of COVID-19