SARS-CoV2 InfectionPhase 2/3NCT05283954
Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression Progression in Papua New Guinea
A Phase 2/3 study testing Combination regimen: Fluoxetine, Prednisolone, Ivermectin and Combination regimen: Albendazole, Vitamin C in people with SARS-CoV2 Infection and COVID-19, run by Oriol Mitja.
Trial summary
The Fluo-Pred-Iver clinical trial will test the efficacy of a combined regimen of Fluoxetine, Prednisolone and Ivermectin (Fluo-Pred-Iver), as treatment for ambulatory patients with mild COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- SARS-CoV2 Infection, COVID-19
- What is being tested?
- Combination regimen: Fluoxetine, Prednisolone, Ivermectin and Combination regimen: Albendazole, Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 30 Jul 2022
- Phase
- Phase 2/3
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female individuals of ≥18 years old.
- In women of childbearing potential, negative pregnancy test at inclusion/baseline visit.
- Has confirmed SARS-CoV-2 infection as determined by PCR, a validated NAAT (i.e., GeneXpert), or validated antigen rapid diagnostic test from nasopharyngeal swabs ≤5 days prior to inclusion/baseline visit.
- Symptomatic with mild COVID-19 with symptoms onset date ≤ 7 days prior to inclusion/baseline visit. Mild COVID-19, as defined per NIH: Individuals who have any of the common signs and/or symptoms of COVID-19 (i.e., fever, cough, sore throat, malaise, headache, muscle pain) without shortness of breath, dyspnoea, or abnormal chest imaging.
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
- Has understood the information provided and capable of giving informed consent.
Who cannot join
- If female, pregnant or breastfeeding, or planning a pregnancy during the study.
- Moderate COVID-19, as defined per NIH:
- Moderate COVID-19: Individuals who have evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (SpO2) ≥94% on room air at sea level.
- Severe or critical COVID-19, as defined per NIH:
- Severe COVID-19: respiratory frequency >30 breaths per minute, SpO2 <94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mmHg, or lung infiltrates >50%.
- Critical COVID-19: respiratory failure, septic shock, and/or multiple organ dysfunction.
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- History of previous confirmed SARS-CoV-2 infection.
- History of significantly abnormal liver function (Child Pugh C).
- History of chronic kidney disease (CKD) ≥ stage 4 or need of dialysis treatment.
- Any pre-existing condition that increases risk of thrombosis.
- History of allergic reactions to ivermectin, fluoxetine, prednisolone, or vitamins C, albendazole, any of its excipients.
- Concomitant use of medications that are highly dependent of CYP 2D6 for clearance and for which elevated plasma concentrations may be associated with serious and/or life-threatening events.
- Phenytoin
- Tricyclic antidepressants
- Antipsychotics: phenothiazines (i.e., chlorpromazine) haloperidol and most atypical (i.e., amitriptyline, aripiprazole, brexpiprazole, risperidone).
- Donepezil
- Tamoxifen
- Antiarrhytmics: propafenone, flecainide
- Amphetamine
- Concomitant use of SSRIs, SNRIs, or tricyclic antidepressants, linezolid, or methylene blue (rationale: increased risk of serotonin syndrome or TCA overdose).
- Concomitant use of drugs that could prolong the QT interval:
- Specific antipsychotics: ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol
- Specific antibiotics: erythromycin, gatifloxacin, moxifloxacin, sparfloxacin
- Class 1A antiarrhytmics: amiodarone, sotalol
- Concomitant use of donepezil (S1R agonist) or sertraline (S1R antagonist)
- Uncontrolled psychiatric disorders, or suicidal ideation.
- Inability to consent and/or comply with study protocol, in the opinion of the investigator.
About this study
Official title: Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression in Papua New Guinea: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
The Fluo-Pred-Iver clinical trial will test the efficacy of a combined regimen of Fluoxetine, Prednisolone and Ivermectin (Fluo-Pred-Iver), as treatment for ambulatory patients with mild COVID-19. The overarching idea of the work proposed herein is to investigate the use of Fluo-Pred-Iver to treat COVID-19, conducting a randomized controlled clinical trial to evaluate a new indication for these widely available drugs. It is estimated to include 954 participants.
Read the detailed description
In this study, individuals who have a confirmed SARS-CoV-2 infection, as determined by a PCR or antigen rapid diagnostic test within the last 5 days, will be informed about the study.
Interested participants will be screened for eligibility criteria by research study staff. After review of inclusion and exclusion criteria, informed consent will be obtained. Participants who consent will be randomized to receive a combined regimen of Fluoxetine, Prednisolone and Ivermectin (Fluo-Pred-Iver), or a combined regimen of Albendazole and Vitamin C as control.
Patients will be followed remotely and/or in persona with visits on day 3, 7, 10 and 14 after inclusion. The primary objective will be to measure the proportion of a composite endpoint of moderate, severe or critical COVID-19 (as defined by NIH) and Emergency Department attendance of hospitalization, or death up to day 14. The reduction of SARS-CoV-2 viral load at day 7 measured by RT-qPCR will also be evaluated.
As secondary endpoints, the therapeutic potential of early administration of the combined regimen Fluo-Pred-Iver in reducing WHO Clinical progression scale score and the safety and tolerability of Fluo-Pred-Iver will be evaluated.
- Conditions
- SARS-CoV2 Infection, COVID-19
- Being tested
- Combination regimen: Fluoxetine, Prednisolone, Ivermectin, Combination regimen: Albendazole, Vitamin C
- Keywords
- Ivermectin, Fluoxetin, Prednisolone
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination regimen: Fluoxetine, Prednisolone, IvermectinDrug
Subjects will receive the following treatments:
Fluoxetine 20 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 09 days.
Prednisolone 25 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 04 days.
Ivermectin 3 mg oral tablets: Tablets started right after randomization (Day 0; 400mcg/ kg dosing), administered once a day for 05 consecutive days.
Combination regimen: Albendazole, Vitamin CDrug
Subjects will receive the following treatments:
Vitamin C 50 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 09 days.
Albendazole 200 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 04 days.
Vitamin C 50 mg oral tablets: Tablets started right after randomization (Day 0; 130mcg/ kg dosing), administered once a day for 05 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Combined Regime of Fluoxetine, Prednisolone and Ivermectin | Experimental | Fluoxetine: 20mg tablet; 20 mg; once daily for 10 days; oral
Prednisolone: 25 mg tablet; 25mg; once daily for 5 days; oral
Ivermectin: 3 mg tablet; 0.4 mg/kg; once daily for 5 days; oral Receives: Drug: Combination regimen: Fluoxetine, Prednisolone, Ivermectin |
| Combination of Vitamin C and Albendazole | Other | Vitamin C: 50 mg tablet; 1 tablet; Once daily for 10 days; Oral
Albendazole; 200 mg; 1 tablet; Once daily for 5 days; Oral
Vitamin C: 50 mg tablet; 0.13 tablet/kg*; Once daily for 5 days; Oral
*Same number of tablets than for Ivermectin Receives: Drug: Combination regimen: Albendazole, Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 disease progression
This is a composite endpoint of moderate, severe or critical COVID-19 and Emergency Room attendace or hospitalization, or death
Measured: Up to 14 days after administration of investigational medicinal product (IMP)
SARS-CoV-2 viral load
Reduction in SARS-CoV-2 viral load in nasopharyngeal swabs at day 7 after start of treatment, as determined by RT-qPCR
Measured: Up to 7 days after administration of IMP
Secondary outcomes (2)
COVID-19 WHO Clinical progression scale score
Change in COVID-19 WHO Clinical progression scale score
Measured: Up to 14 days after administration of IMP
Adverse Events
Incidence of Adverse Events
Measured: Up to 14 days after administration of IMP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 May 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oriol Mitja
- Sponsor type
- University, hospital or other
- Collaborators
- National Department of Health, Papua New Guinea, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Responsible party
- Sponsor-investigator, Oriol Mitja, Lihir Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283954
- Sponsor's protocol ID
- Fluo-Pred-Iver
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2022
- Last updated
- 9 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Combined Regimen of Fluoxetine, Prednisolone and Ivermectin in the Treatment of Mild COVID-19 to Prevent Disease Progression in Papua New Guinea: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05283954
- Acronym / sponsor ID
- Fluo-Pred-Iver
- Conditions
- SARS-CoV2 Infection, COVID-19
- Keywords
- Ivermectin, Fluoxetin, Prednisolone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Oriol MitjaUniversity, hospital or other
- Collaborators
- National Department of Health, Papua New Guinea, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 17 Mar 2022 (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.
The Fluo-Pred-Iver clinical trial will test the efficacy of a combined regimen of Fluoxetine, Prednisolone and Ivermectin (Fluo-Pred-Iver), as treatment for ambulatory patients with mild COVID-19. The overarching idea of the work proposed herein is to investigate the use of Fluo-Pred-Iver to treat COVID-19, conducting a randomized controlled clinical trial to evaluate a new indication for these widely available drugs. It is estimated to include 954 participants.
Detailed description
In this study, individuals who have a confirmed SARS-CoV-2 infection, as determined by a PCR or antigen rapid diagnostic test within the last 5 days, will be informed about the study.
Interested participants will be screened for eligibility criteria by research study staff. After review of inclusion and exclusion criteria, informed consent will be obtained. Participants who consent will be randomized to receive a combined regimen of Fluoxetine, Prednisolone and Ivermectin (Fluo-Pred-Iver), or a combined regimen of Albendazole and Vitamin C as control.
Patients will be followed remotely and/or in persona with visits on day 3, 7, 10 and 14 after inclusion. The primary objective will be to measure the proportion of a composite endpoint of moderate, severe or critical COVID-19 (as defined by NIH) and Emergency Department attendance of hospitalization, or death up to day 14. The reduction of SARS-CoV-2 viral load at day 7 measured by RT-qPCR will also be evaluated.
As secondary endpoints, the therapeutic potential of early administration of the combined regimen Fluo-Pred-Iver in reducing WHO Clinical progression scale score and the safety and tolerability of Fluo-Pred-Iver will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Regime of Fluoxetine, Prednisolone and Ivermectin | Experimental | Drug: Combination regimen: Fluoxetine, Prednisolone, IvermectinFluoxetine: 20mg tablet; 20 mg; once daily for 10 days; oral Prednisolone: 25 mg tablet; 25mg; once daily for 5 days; oral Ivermectin: 3 mg tablet; 0.4 mg/kg; once daily for 5 days; oral |
| Combination of Vitamin C and Albendazole | Other | Drug: Combination regimen: Albendazole, Vitamin CVitamin C: 50 mg tablet; 1 tablet; Once daily for 10 days; Oral Albendazole; 200 mg; 1 tablet; Once daily for 5 days; Oral Vitamin C: 50 mg tablet; 0.13 tablet/kg*; Once daily for 5 days; Oral *Same number of tablets than for Ivermectin |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult male or female individuals of ≥18 years old.
- In women of childbearing potential, negative pregnancy test at inclusion/baseline visit.
- Has confirmed SARS-CoV-2 infection as determined by PCR, a validated NAAT (i.e., GeneXpert), or validated antigen rapid diagnostic test from nasopharyngeal swabs ≤5 days prior to inclusion/baseline visit.
- Symptomatic with mild COVID-19 with symptoms onset date ≤ 7 days prior to inclusion/baseline visit. Mild COVID-19, as defined per NIH: Individuals who have any of the common signs and/or symptoms of COVID-19 (i.e., fever, cough, sore throat, malaise, headache, muscle pain) without shortness of breath, dyspnoea, or abnormal chest imaging.
- Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
Key exclusion criteria (27 listed)
- If female, pregnant or breastfeeding, or planning a pregnancy during the study.
- Moderate COVID-19, as defined per NIH:
- Severe or critical COVID-19, as defined per NIH:
- History of previous confirmed SARS-CoV-2 infection.
- History of significantly abnormal liver function (Child Pugh C).
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 |
|---|---|---|
| Combination regimen: Fluoxetine, Prednisolone, IvermectinSubjects will receive the following treatments: Fluoxetine 20 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 09 days. Prednisolone 25 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 04 days. Ivermectin 3 mg oral tablets: Tablets started right after randomization (Day 0; 400mcg/ kg dosing), administered once a day for 05 consecutive days. | Drug | Combined Regime of Fluoxetine, Prednisolone and Ivermectin |
| Combination regimen: Albendazole, Vitamin CSubjects will receive the following treatments: Vitamin C 50 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 09 days. Albendazole 200 mg oral tablets: One tablet right after randomization (Day 0) followed by one daily tablet for the following 04 days. Vitamin C 50 mg oral tablets: Tablets started right after randomization (Day 0; 130mcg/ kg dosing), administered once a day for 05 consecutive days. | Drug | Combination of Vitamin C and Albendazole |
Primary outcome
COVID-19 disease progression
Time frame: Up to 14 days after administration of investigational medicinal product (IMP)
This is a composite endpoint of moderate, severe or critical COVID-19 and Emergency Room attendace or hospitalization, or death
SARS-CoV-2 viral load
Time frame: Up to 7 days after administration of IMP
Reduction in SARS-CoV-2 viral load in nasopharyngeal swabs at day 7 after start of treatment, as determined by RT-qPCR
2 secondary outcomes
COVID-19 WHO Clinical progression scale score
Time frame: Up to 14 days after administration of IMP
Adverse Events
Time frame: Up to 14 days after administration of IMP
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Combination regimen: Fluoxetine, Prednisolone, Ivermectin and Combination regimen: Albendazole, Vitamin C in people with SARS-CoV2 Infection and COVID-19, run by Oriol Mitja.
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 6 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: withdrawn, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
COVID-19 disease progression (time frame: Up to 14 days after administration of investigational medicinal product (IMP)). The study lists 2 primary outcomes in all. 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 9 Mar 2023.