Status:
WITHDRAWN
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
Lead Sponsor:
Oriol Mitja
Collaborating Sponsors:
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
Conditions:
SARS-CoV2 Infection
COVID-19
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
PHASE3
Brief 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. 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 part...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- If female, pregnant or breastfeeding, or planning a pregnancy during the study.
- Moderate COVID-19, as defined per NIH:
- a. 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.
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05283954
Start Date
May 1 2022
End Date
July 30 2022
Last Update
March 9 2023
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