Covid19Phase 2NCT04718480
Fluvoxamine Administration in Moderate SARS-CoV-2 (COVID-19) Infected Patients
A Phase 2 study testing Fluvoxamine in people with Covid19, run by SigmaDrugs Research Ltd. at 4 sites in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19
- What is being tested?
- Fluvoxamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 4 sitesHungary
- Study dates
- 27 Nov 2020to 31 May 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Hungary4 sites
Dél-pesti Centrumkórház
Budapest, 1097
Semmelweis Egyetem Pulmonológiai Klinika
Budapest, H-1083
Országos Korányi Pulmonológiai Intézet
Budapest, H-1121
Debreceni Egyetem Kenézy Gyula Kórház Infektológia
Debrecen, 4032
About this study
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
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
- Being tested
- Placebo, Fluvoxamine
- Keywords
- moderate COVID-19; fluvoxamine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
po placebo tablets
FluvoxamineDrug
po fluvoxamine tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 2 x 100 mg placebo daily po. (with careful dose escalation and tapered dose reduction). Overall treatment period is 74 days. Receives: 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. Receives: Drug: Fluvoxamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical recovery after treatment
days from randomization (Day 1) to ANY THREE items of the following four:
- resolution from fever (oral or tympanic temperature ≤ 37.5 °C, axillary ≤ 37.0 °C for at least 48 hours without antipyretics)
- return of respiratory rate to normal (≤ 20 / min)
- normalization of SpO2 ( ≥95% on room air )
- cough remission (any reduction in cough-burden Visual Analogue Scale, compared to Day 1 baseline)
Measured: 74 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start27 Nov 2020
- Primary completion15 Mar 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, adaptive design add-on treatment study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- SigmaDrugs Research Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718480
- Sponsor's protocol ID
- SD-COVID19-01
- Other IDs
- 2020-002299-11
- Status last verified
- Aug 2022
- First submitted
- 18 Jan 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study results will be published at the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04718480
- Acronym / sponsor ID
- SD-COVID19-01
- Conditions
- Covid19
- Keywords
- moderate COVID-19; fluvoxamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- SigmaDrugs Research Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, adaptive design add-on treatment study.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo2 x 100 mg placebo daily po. (with careful dose escalation and tapered dose reduction). Overall treatment period is 74 days. |
| Fluvoxamine | Experimental | Drug: Fluvoxamine2 x 100 mg fluvoxamine daily po. (with careful dose escalation and tapered dose reduction). Overall treatment period is 74 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (27 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebopo placebo tablets | Drug | Placebo |
| Fluvoxaminepo fluvoxamine tablets | Drug | Fluvoxamine |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No. Study results will be published at the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluvoxamine in people with Covid19, run by SigmaDrugs Research Ltd. at 4 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical recovery after treatment (time frame: 74 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.