FLCCC Protocol with Ivermectin: Not Recommended Based on Current Evidence
I cannot recommend the FLCCC (Front Line COVID-19 Critical Care Alliance) protocols for COVID-19 treatment, as the highest quality evidence demonstrates that ivermectin has no proven efficacy for COVID-19 prevention or treatment, and established guidelines do not support its use. 1, 2
Why the FLCCC Protocol Is Not Evidence-Based
Ivermectin Lacks Proven Efficacy
A comprehensive Cochrane systematic review found very low- to low-certainty evidence for ivermectin in COVID-19, concluding that "the reliable evidence available does not support the use of ivermectin for treatment or prevention of COVID-19 outside of well-designed randomized trials." 1
Phase III randomized controlled trials consistently showed that ivermectin, when compared to standard care or placebo, did not reduce disease severity, need for mechanical ventilation, ICU admission, or in-hospital mortality. 2
The Surviving Sepsis Campaign guidelines (2020) found insufficient evidence to issue any recommendation on ivermectin or other unproven antivirals for critically ill COVID-19 patients. 3
What the FLCCC Protocol Claims vs. Reality
The FLCCC developed two protocols: 4
- MATH+ Protocol (for hospitalized patients): methylprednisolone, ascorbic acid, thiamine, heparin, plus ivermectin and supplements 4
- I-MASK+ Protocol (for prevention and outpatient treatment): ivermectin-based with supplements 4
However, these protocols were published without rigorous randomized controlled trial evidence, and the authors themselves considered performing such trials "unethical" based on their observational data—a position that contradicts evidence-based medicine principles. 4
What Actually Works: Evidence-Based COVID-19 Management
For Hospitalized Patients WITH Hypoxia (Requiring Oxygen)
Dexamethasone 6 mg daily for 10 days reduces mortality by 3% absolute risk reduction and should be initiated immediately upon oxygen requirement. 5
Prophylactic-dose anticoagulation (low molecular weight heparin preferred) is strongly recommended for all hospitalized COVID-19 patients. 5
For moderate-to-severe ARDS, prone ventilation for 12-16 hours is suggested. 3
For Hospitalized Patients WITHOUT Hypoxia
Do NOT give corticosteroids to non-hypoxic patients—this provides no benefit and causes harm through immunosuppression, hyperglycemia, and increased infection risk (mortality 14.0% vs 17.8% in standard care vs dexamethasone groups). 5
Continue prophylactic anticoagulation regardless of oxygen requirement. 5
What to Avoid Based on Guidelines
Hydroxychloroquine/chloroquine: Strongly recommended AGAINST—no benefit and potential for worse outcomes and severe side effects. 5, 2
Lopinavir/ritonavir: Suggested AGAINST for routine use. 3
Azithromycin: Strongly recommended AGAINST unless documented bacterial co-infection exists—adding azithromycin to standard care did not result in clinical improvement. 5, 2
Ivermectin: Insufficient evidence; not recommended outside clinical trials. 1, 2
Critical Pitfalls to Avoid
Do not use unproven therapies based on in vitro data alone—ivermectin, chloroquine/hydroxychloroquine, and azithromycin all showed mechanistic effects against SARS-CoV-2 in laboratory settings but failed to demonstrate clinical benefit in phase III trials. 2
Do not give corticosteroids prematurely—they are harmful in non-hypoxic patients and should only be initiated when oxygen is required (SpO2 <92%). 5
Do not delay evidence-based interventions—focus on proven therapies (corticosteroids for hypoxic patients, anticoagulation, supportive care) rather than unproven protocols. 3, 5
Monitoring and Escalation
Monitor oxygen saturation at least twice daily, with target SpO2 no higher than 96% if supplemental oxygen is necessary. 5, 6
Start supplemental oxygen when SpO2 falls below 92%, and strongly recommend oxygen when SpO2 <90%. 3, 6
Monitor respiratory rate at least twice daily—this is often the earliest sign of deterioration before oxygen desaturation occurs. 5, 6