At a glance
ClinicalIndex Comparison Record- ✓Age over 18 years with ability to provide informed consent
- ✓Acute flu-like symptoms less than 7 days duration
- ✓At least one risk/enhancement criteria including age >50, diabetes, hypertension, cardiovascular disease, lung disease, asthma, obesity (BMI >30), transplant, stage IV CKD/dialysis, fever >38°C, specific respiratory symptoms, immunosuppression, or cancer history in last 5 years
- ✓Positive SARS-CoV-2 antigen rapid test at screening or positive diagnostic test within 7 days of symptom onset
- ✕Negative SARS-CoV-2 diagnostic test (unless early negative followed by later positive within 7 days)
- ✕Acute respiratory condition requiring hospitalization decision at primary care
- ✕Acute respiratory symptoms from other causes
- ✕Dyspnea secondary to other respiratory causes or infections (COPD, bronchitis, non-viral pneumonia, PAH)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04727424Phase 3RecruitingUpdate OverdueUpdated 25mo ago · Completion was 25mo agoA 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
In Brief
A Phase 3 clinical trial evaluating Spirulin Platensis, Budesonide Powder, and 2 other interventions for Covid19 and SARS-Associated Coronavirus. Currently recruiting, targeting 7,819 participants across 12 sites.
Signals
Detailed 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.
Study Details
Timeline
Interventions
Two tablets every 12 hours since randomization through day 09 following randomization
One Fluvoxamine tablet every 12 hours since randomization through day 09. PLUS 01 Budesonide powder (inhalation) every 12 hours since randomization through day 09.
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.
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)