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RECRUITING
NCT04727424
PHASE3

Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms

Sponsor: Cardresearch

View on ClinicalTrials.gov

Summary

The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in patients with early-onset disease and mild symptoms. Experimental studies have demonstrated a potential anti-inflammatory role of Fluvoxamine, Fluoxetine, Budesonide and Spirulin Platensis in SARS-CoV-2 infections and observational studies have suggested a reduced complications in patients with COVID-19 disease.

Official title: A Multicenter, Prospective, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Fluvoxamine Plus Budesonide, Fluoxetine Plus Budesonide and Spirulin Platensis, in High Risk Patients With Mild COVID-19

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

7819

Start Date

2021-01-19

Completion Date

2024-07-01

Last Updated

2024-05-08

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Spirulin Platensis

Two tablets every 12 hours since randomization through day 09 following randomization

DRUG

Budesonide Powder

One Fluvoxamine tablet every 12 hours since randomization through day 09. PLUS 01 Budesonide powder (inhalation) every 12 hours since randomization through day 09.

DRUG

Fluoxetine 20 MG

Two Fluoxetine tablets every day starting just after randomization through day 07. PLUS 01 Budesonide powder (inhalation) every 12 hours since randomization through day 07.

DRUG

Placebo

Placebo oral tablets (10-day schedule): Matching tablets started after randomization using the dosing regimen of 01 tablet every 12 hs starting at Randomization Day (Day 0) until end of Day 09 (total of 10 day schedule) PLUS Placebo Inhalation Therapy: One dosing (inhalation puff) right after randomization (Day 0) followed by one puff BID for the following 09 days OR Paracetamol (07-day schedule - active comparator): Paracetamol 500 mg tablets started after randomization using the dosing regimen of 01 tablet BID starting at Rand. Day (Day 0) until end of Day 06 (total of 07 days schedule - ANTICOV Arm) OR Matching tablets started after randomization using the dosing regimen of 02 tablets every 12 hs starting at Randomization Day (Day 0) until end of Day 09 (total of 10 day schedule)

Locations (12)

CARDRESEARCH - Cardiologia Assistencial e de Pesquisa

Belo Horizonte, Minas Gerais, Brazil

City of Betim

Betim, Minas Gerais, Brazil

City of Brumadinho

Brumadinho, Minas Gerais, Brazil

Hospital e Maternidade Santa Rita

Contagem, Minas Gerais, Brazil

City of Governador Valadares

Governador Valadares, Minas Gerais, Brazil

City of Ibirité

Ibirité, Minas Gerais, Brazil

City of Igarapé

Igarapé, Minas Gerais, Brazil

Centro Universitário FIPMOC

Montes Claros, Minas Gerais, Brazil

City of Nova Lima

Nova Lima, Minas Gerais, Brazil

Universidade Federal de Ouro Preto

Ouro Preto, Minas Gerais, Brazil

City of Santa Luzia

Santa Luzia, Minas Gerais, Brazil

City of Sete Lagoas

Sete Lagoas, Minas Gerais, Brazil