NCT05283954

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

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

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Oriol Mitja · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-06-30
• Completion: 2022-07-30
• First posted: 2022-03-17
• Last updated: 2023-03-09