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

NCT05283954 | Withdrawn Phase 2

• 1 other identifier: Fluo-Pred-Iver
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

SARS-CoV2 Infection; COVID-19

Keywords

Ivermectin; Fluoxetin; Prednisolone

Outcome Measures

Primary Outcomes (2)

• COVID-19 disease progression

  This is a composite endpoint of moderate, severe or critical COVID-19 and Emergency Room attendace or hospitalization, or death

  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

  Up to 7 days after administration of IMP

Secondary Outcomes (2)

• COVID-19 WHO Clinical progression scale score

  Up to 14 days after administration of IMP

• Adverse Events

  Up to 14 days after administration of IMP

Study Arms (2)

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

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

Drug: Combination regimen: Albendazole, Vitamin C

Interventions

Combination regimen: Fluoxetine, Prednisolone, Ivermectin DRUG

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.

Combined Regime of Fluoxetine, Prednisolone and Ivermectin

Combination regimen: Albendazole, Vitamin C DRUG

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.

Combination of Vitamin C and Albendazole

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female individuals of ≥18 years old.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Oriol Mitja: lead
• National Department of Health, Papua New Guinea: collaborator
• Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

Prednisolone; Ivermectin; Ascorbic Acid

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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Macrolides; Polyketides; Lactones; Organic Chemicals; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Community Health Program Director

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 17, 2022
• Study Start: May 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 30, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-03