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

NCT04718480 | Completed Phase 2

• 2 other identifiers: SD-COVID19-012020-002299-11
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

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).

Conditions

Covid19

Keywords

moderate COVID-19; fluvoxamine

Outcome Measures

Primary Outcomes (1)

• Time to clinical recovery after treatment

  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)

  74 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

2 x 100 mg placebo daily po. (with careful dose escalation and tapered dose reduction). Overall treatment period is 74 days.

Drug: Placebo

Fluvoxamine

EXPERIMENTAL

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

Drug: Fluvoxamine

Interventions

Placebo DRUG

po placebo tablets

Placebo

Fluvoxamine DRUG

po fluvoxamine tablets

Fluvoxamine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SigmaDrugs Research Ltd.: lead

Study Sites (4)

Dél-pesti Centrumkórház

Budapest, 1097, Hungary

Location

Semmelweis Egyetem Pulmonológiai Klinika

Budapest, H-1083, Hungary

Location

Országos Korányi Pulmonológiai Intézet

Budapest, H-1121, Hungary

Location

Debreceni Egyetem Kenézy Gyula Kórház Infektológia

Debrecen, 4032, Hungary

Location

MeSH Terms

Conditions

COVID-19

Interventions

Fluvoxamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind, placebo-controlled,
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, adaptive design add-on treatment study.

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: November 27, 2020
• Primary Completion: March 15, 2022
• Study Completion: May 31, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

HU (4)