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 Pegilatrd
Interferon Lambda in SARS-CoV-2 infections and observational studies have suggested a reduced
complications in patients with COVID-19 disease.
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
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
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
Important considerations on TOGETHER Trial:
Vaccinated patients were proposed to be an exclusion criteria on amendment 3 which was
received final National Ethics Committee (CONEP) decision letter number 4.747.755_E3
dated June 01, 2021. We evaluated vaccination data and outcomes on two large cities
involving 150.000 individuals and based on these results we submitted to the IRB a
notification request to withdraw the exclusion criteria 4 (vaccination > 14 days) on
July 14, 2021, which was granted.
The amendment 5 proposed a collaborative partnership with ANTICOV Consortia and
incorporating the fluoxetine + budesonide and its active comparator (paracetamol) arms,
as per ANTICOV protocol WHO ERC approval version 13.0. These generated data will be
analyzed along with ANTICOV fluoxetine + budesonide and paracetamol arms.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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