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

Covid19 Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

In December 2019 a series of viral pneumonia cases were reported in the city of Wuhan, China and a new subtype of coronavirus has been identified as the causative agent of this condition. On February 11, 2000 the disease has been characterized as COVID-19 and on March 11 the World Health Organization (WHO) declared a state of worldwide pandemic. On January 25, 2021 there are 98,794,942 cases and 2,124,193 documented deaths (global case-fatality ratio of 2.15%). To date, no early treatment has been identified as effective in combating this disease which has been identified as with high morbidity and mortality. Epidemiological data suggest that despite development of vaccines we will have hundreds od thousands of cases in the next two years. Thus, we propose the prospective, double-blinded, randomized evaluation of potential therapies against SARS-CoV2 and some clinical evidence derived from observational studies on reducing complications if used early on the disease, before inflammatory cascade is fully activated. Important considerations on TOGETHER Adaptive Trial: 1. The Pegylated Lambda interferon arm was ended on early February 2022. 2. The Proposal of a new arm: Spirulin platensis. 3. The Modification on primary endpoints that will be effective only for new arms added to the trial (Spirulin platensis). ;

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-Associated Coronavirus
• Severe Acute Respiratory Syndrome

• NCT number: NCT04727424
• Study type: Interventional
• Source: Cardresearch
• Contact: Gilmar Reis, MD, PhD
• Phone: +553132416574
• Email: administrador@cardresearch.org
• Status: Recruiting
• Phase: Phase 3
• Start date: January 19, 2021
• Completion date: July 1, 2024