Trial NCT04727424
Publication Reis G, Lancet Glob, 2021 (published paper)
Dates: 2021-01-20 to 2021-08-05
Funding: Public/non profit (FastGrants; The Rainwater Foundation.)
Conflict of interest: No
| Methods | |
| RCT Blinding: quadruple blinding | |
| Location :
Multicenter / Brazil Follow-up duration (days): 28 | |
| Inclusion criteria | Patients older than 18 years; Presenting to an outpatient care setting with an acute clinical condition consistent with COVID-19 and symptoms beginning within 7 days of the screening date, or positive rapid test for SARS-CoV-2 antigen done at the time of screening or patient with positive SARS-CoV-2 diagnostic test within 7 days of symptom onset; At least one additional criterion for high risk: diabetes; systemic arterial hypertension requiring at least one oral medication for treatment; known cardiovascular disease (heart failure, congenital heart disease, valve disease, coronary artery disease, cardiomyopathies being treated, clinically manifested heart disease and with clinical repercussion); symptomatic lung disease or treatment for such (emphysema, fibrosing diseases); symptomatic asthma requiring chronic use of agents to control symptoms; smoking; obesity, defined as body-mass index greater than 30 kg/m² (weight and height information provided by the patient); having had a transplant; stage IV chronic kidney disease or on dialysis; immunosuppression or use of corticosteroid therapy (equivalent to at least 10 mg of prednisone per day) or immunosuppressive therapy; history of cancer in the last 0·5 years or undergoing current cancer treatment or aged 50 years or older; and unvaccinated status; patients with negative test taken early and becoming positive a few days later were eligible, if they were less than 7 days after the onset of flu-like symptoms |
| Exclusion criteria | Diagnostic examination for SARS-CoV-2 negative associated with acute flu-like symptoms; Acute respiratory condition compatible with COVID-19 treated in primary care and previously requiring hospitalisation; Acute respiratory condition owing to other causes; Received vaccination for SARS-CoV-2; Dyspnoea secondary to other acute and chronic respiratory causes or infections (eg, decompensated chronic obstructive pulmonary disease, acute bronchitis, pneumonia, primary pulmonary arterial hypertension); Current use of SSRIs (use of other serotonin reuptake inhibitors were not excluded); Uncontrolled psychiatric disorders or suicidal ideation; inability or unwillingness to follow research guidelines and procedures; Pregnant. |
| Interventions | |
| Treatment
Fluvoxamine 100 mg orally twice a day for 10 days |
|
| Control
Placebo | |
| Participants | |
| Randomized 1497 participants (n1=741 / n2= 756) | |
| Characteristics of participants N=1497 Mean age : NR 635 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register 1. Rate of fluvoxamine, ivermectin, doxasozin, peginterferon Lambda and peginterferon beta in changing the need for emergency care AND observation for more than 06 hours due to the worsening of COVID-19; [ Time Frame: 28 days ] Evaluation of emergency visits and observation unit stay > 06 hours 2. Rate of fluvoxamine, ivermectin, doxasozin, peginterferon lambda and peginterferon beta in changing need for Hospitalization due to COVID-19 progression and related complications, including lower respiratory tract infection (LRTI) [ Time Frame: 28 days ] Hospitalization due to COVID-19 progression and related complications | |
| In the report Composite endpoint of medical admission to a hospital setting due to COVID-19- related illness defined as COVID-19 emergency setting visits with participants remaining under observation for more than 6 h or referral to further hospitalisation due to the progression of COVID-19 within 28 days of randomisation. | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment |
In addition to the published article, the pre-print, the study registry, master protocol, supplementary appendix and statistical analysis plan were used in data extraction and risk of bias assessment. There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper. A number of secondary outcomes in the registry (WHO ordinal scale, time in ICU, Health and Functioning after COVID-19 disease) were not reported in the published article.
This study was updated on November 17th, 2021 with data from the published journal report. |