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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05283954
Recruitment Status : Withdrawn (Lack of funding)
First Posted : March 17, 2022
Last Update Posted : March 9, 2023
Sponsor:
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
Information provided by (Responsible Party):
Oriol Mitja, Lihir Medical Centre

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 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.

Condition or disease Intervention/treatment Phase
SARS-CoV2 Infection COVID-19 Drug: Combination regimen: Fluoxetine, Prednisolone, Ivermectin Drug: Combination regimen: Albendazole, Vitamin C Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 1, 2022
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : July 30, 2022


Arm Intervention/treatment
Experimental: Combined Regime of Fluoxetine, Prednisolone and Ivermectin

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

Drug: Combination regimen: Fluoxetine, Prednisolone, Ivermectin

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 of Vitamin C and Albendazole

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

Drug: Combination regimen: Albendazole, Vitamin C

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.





Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. COVID-19 WHO Clinical progression scale score [ Time Frame: Up to 14 days after administration of IMP ]
    Change in COVID-19 WHO Clinical progression scale score

  2. Adverse Events [ Time Frame: Up to 14 days after administration of IMP ]
    Incidence of Adverse Events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult male or female individuals of ≥18 years old.
  2. In women of childbearing potential, negative pregnancy test at inclusion/baseline visit.
  3. 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.
  4. 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.
  5. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
  6. Has understood the information provided and capable of giving informed consent.

Exclusion Criteria:

  1. If female, pregnant or breastfeeding, or planning a pregnancy during the study.
  2. 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.

  3. Severe or critical COVID-19, as defined per NIH:

    1. 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%.
    2. Critical COVID-19: respiratory failure, septic shock, and/or multiple organ dysfunction.
  4. History of previous confirmed SARS-CoV-2 infection.
  5. History of significantly abnormal liver function (Child Pugh C).
  6. History of chronic kidney disease (CKD) ≥ stage 4 or need of dialysis treatment.
  7. Any pre-existing condition that increases risk of thrombosis.
  8. History of allergic reactions to ivermectin, fluoxetine, prednisolone, or vitamins C, albendazole, any of its excipients.
  9. 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.

    1. Phenytoin
    2. Tricyclic antidepressants
    3. Antipsychotics: phenothiazines (i.e., chlorpromazine) haloperidol and most atypical (i.e., amitriptyline, aripiprazole, brexpiprazole, risperidone).
    4. Donepezil
    5. Tamoxifen
    6. Antiarrhytmics: propafenone, flecainide
    7. Amphetamine
  10. Concomitant use of SSRIs, SNRIs, or tricyclic antidepressants, linezolid, or methylene blue (rationale: increased risk of serotonin syndrome or TCA overdose).
  11. Concomitant use of drugs that could prolong the QT interval:

    1. Specific antipsychotics: ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol
    2. Specific antibiotics: erythromycin, gatifloxacin, moxifloxacin, sparfloxacin
    3. Class 1A antiarrhytmics: amiodarone, sotalol
  12. Concomitant use of donepezil (S1R agonist) or sertraline (S1R antagonist)
  13. Uncontrolled psychiatric disorders, or suicidal ideation.
  14. Inability to consent and/or comply with study protocol, in the opinion of the investigator.
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Responsible Party: Oriol Mitja, Community Health Program Director, Lihir Medical Centre
ClinicalTrials.gov Identifier: NCT05283954    
Other Study ID Numbers: Fluo-Pred-Iver
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Oriol Mitja, Lihir Medical Centre:
Ivermectin
Fluoxetin
Prednisolone
Additional relevant MeSH terms:
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COVID-19
Disease Progression
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Ivermectin
Albendazole
Prednisolone
Fluoxetine
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Selective Serotonin Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators