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Table 7b. Ivermectin: Selected Clinical Trial Data

Last Updated: December 20, 2023

The clinical trials described in this table are RCTs that had the greatest impact on the Panel’s recommendation. The Panel reviewed other clinical studies of IVM for the treatment of COVID-19.1-26 However, those studies have limitations that make them less definitive and informative than the studies summarized in the table.

Table 7b. Ivermectin: Selected Clinical Trial Data
Methods Results Limitations and Interpretation
ACTIV-6: Double-Blind RCT of Ivermectin 600 μg/kg Once Daily in Outpatients With Mild to Moderate COVID-19 in the United States27

Key Inclusion Criteria

  • Aged ≥30 years
  • Not hospitalized
  • Positive SARS-CoV-2 test result within past 10 days
  • ≥2 COVID-19 symptoms for ≤7 days

Key Exclusion Criteria

  • End-stage kidney disease
  • Liver failure or decompensated cirrhosis

Interventions

  • IVM 600 μg/kg PO once daily for 6 days (n = 602)
  • Placebo (n = 604)

Primary Endpoint

  • Time to sustained recovery (i.e., ≥3 consecutive days without symptoms)

Key Secondary Endpoint

  • Hospitalization or death by Day 28

Safety Endpoint

  • Occurrence of AEs and SAEs

Participant Characteristics 

  • Median age 48 years; 59.1% women
  • 38.1% with BMI >30; 9.2% with DM; 26.8% with HTN
  • 83.6% received ≥2 COVID-19 vaccine doses.
  • Median of 5 days from symptom onset to receipt of study drug

Primary Outcome

  • Median time to sustained recovery: 11 days in IVM arm vs. 11 days in placebo arm (HR 1.02; 95% CrI, 0.92–1.13)

Secondary Outcome

  • Hospitalization or death by Day 28: 5 (0.8%) in IVM arm vs. 2 (0.3%) in placebo arm

Safety Outcomes

  • Occurrence of AEs: 52 of 566 patients (9.2%) in IVM arm vs. 41 of 576 patients (7.1%) in placebo arm
  • Occurrence of SAEs: 5 of 566 patients (0.9%) in IVM arm vs. 3 of 576 patients (0.5%) in placebo arm
Key Limitation 
  • The low number of events limited the power to determine an effect on hospitalization and death.

Interpretation 

  • Among outpatients with COVID-19, IVM 600 μg/kg PO once daily for 6 days did not shorten time to sustained recovery or reduce incidence of hospitalization or death.
ACTIV-6: Double-Blind RCT of Ivermectin 400 μg/kg Once Daily in Outpatients With Mild to Moderate COVID-19 in the United States28

Key Inclusion Criteria

  • Aged ≥30 years
  • Not hospitalized
  • Positive SARS-CoV-2 test result within past 10 days
  • ≥2 COVID-19 symptoms for ≤7 days

Key Exclusion Criteria

  • End-stage kidney disease
  • Liver failure or decompensated cirrhosis

Interventions

  • IVM 400 μg/kg PO once daily for 3 days (n = 817)
  • Placebo (n = 774)

Primary Endpoint

  • Time to sustained recovery (i.e., ≥3 consecutive days without symptoms)

Key Secondary Endpoint

  • Hospitalization or death by Day 28

Safety Endpoint

  • Occurrence of AEs and SAEs

Participant Characteristics

  • Mean age 48 years; 59% women
  • 41% with BMI >30; 11.5% with DM; 26% with HTN
  • 47% received ≥2 COVID-19 vaccine doses.
  • Median of 6 days from symptom onset to receipt of study drug

Primary Outcome

  • Median time to sustained recovery: 12 days in IVM arm vs. 13 days in placebo arm (HR 1.07; 95% CrI, 0.96–1.17)

Secondary Outcome

  • Hospitalization or death by Day 28: 10 (1.2%) in IVM arm vs. 9 (1.2%) in placebo arm

Safety Outcomes

  • Occurrence of AEs: 24 of 766 patients (3.1%) in IVM arm vs. 27 of 724 patients (3.7%) in placebo arm
  • Occurrence of SAEs: 9 of 766 patients (1.2%) in IVM arm vs. 9 of 724 patients (1.2%) in placebo arm

Key Limitation

  • The low number of events limited the power to determine an effect on hospitalization and death.

Interpretation

  • Among outpatients with COVID-19, IVM 400 μg/kg PO once daily for 3 days did not shorten time to sustained recovery or reduce incidence of hospitalization or death.
TOGETHER: Double-Blind, Adaptive RCT of Ivermectin in Nonhospitalized Patients With COVID-19 in Brazil29

Key Inclusion Criteria

  • Positive SARS-CoV-2 antigen test result 
  • Within 7 days of symptom onset
  • ≥1 high-risk factor for disease progression (e.g., aged >50 years, comorbidities, immunosuppression)

Interventions

  • IVM 400 μg/kg PO once daily for 3 days (n = 679)
  • Placebo (n = 679; not all patients received IVM placebo) 

Primary Endpoint

  • Composite of ED observation >6 hours or hospitalization for COVID-19 by Day 28

Key Secondary Endpoints

  • Viral clearance at Day 7
  • All-cause mortality
  • Occurrence of AEs

Participant Characteristics

  • Median age 49 years; 46% aged ≥50 years; 58% women; 95% self-identified as mixed race
  • Most prevalent risk factor: 50% with obesity
  • 44% within 3 days of symptom onset at enrollment

Primary Outcome

  • Composite of ED observation >6 hours or hospitalization for COVID-19 by Day 28 (ITT): 100 (14.7%) in IVM arm vs. 111 (16.4%) in placebo arm (relative risk 0.90; 95% CrI, 0.70–1.16) 
    • 171 (81%) of events were hospitalizations (ITT)

Secondary Outcomes

  • No difference between IVM arm and placebo arm in:
    • Viral clearance at Day 7 (relative risk 1.00; 95% CrI, 0.68–1.46)
    • All-cause mortality: 21 (3.1%) vs. 24 (3.5%) (relative risk 0.88; CrI, 0.49–1.55) 
    • Occurrence of AEs
Key Limitations
  • Health care facility capacity may have influenced the number and duration of ED visits and hospitalizations.
  • No details on safety outcomes (e.g., type of treatment-emergent AEs) other than grading were reported.

Interpretation

  • In outpatients with recent SARS-CoV-2 infection, IVM did not reduce the need for ED visits or hospitalization when compared with placebo.
COVID-OUT: RCT of Metformin, Ivermectin, and Fluvoxamine in Nonhospitalized Adults With COVID-19 in the United States30

Key Inclusion Criteria

  • Aged 30–85 years
  • BMI ≥25 or ≥23 if Asian or Latinx
  • Laboratory-confirmed SARS-CoV-2 infection within 3 days of randomization
  • ≤7 days of COVID-19 symptoms

Key Exclusion Criteria

  • Immunocompromised
  • Hepatic impairment
  • Stage 4–5 chronic kidney disease or eGFR <45 mL/min/1.73 m2

Interventions

  • IVM 390–470 ug/kg PO once daily for 3 days (n = 410) in the following arms:
    • IVM alone (n = 206)
    • Metformin plus IVM (n = 204)
  • IVM control (n = 398), which included the following arms:
    • Placebo alone (n = 203)
    • Metformin alone (n = 195)

Primary Endpoints

  • Composite of hypoxemia (SpO2 ≤93%, as measured by a home pulse oximeter), ED visit, hospitalization, or death by Day 14
  • A prespecified secondary analysis evaluated the occurrence of ED visits, hospitalization, or death by Day 14. 

Key Secondary Endpoints

  • Total symptom severity score by Day 14, as measured by a symptom severity scale
  • Drug discontinuation or interruption

Participant Characteristics

  • Median age 46 years; 56% women; 82% White
  • Median BMI 30 
  • 27% with CVD
  • 52% received primary COVID-19 vaccination series.
  • Mean of 4.8 days of symptoms
  • Approximately 68% enrolled while Delta was the dominant variant; approximately 29% enrolled while Omicron was dominant.

Primary Outcomes

  • Composite of hypoxemia, ED visit, hospitalization, or death by Day 14: 105 (25.8%) in IVM arm vs. 96 (24.6%) in control arm (aOR 1.05; 95% CI, 0.76–1.45, P = 0.78)
  • No difference between IVM alone arm and placebo alone arm in occurrence of primary endpoint (aOR 1.06; 95% CI, 0.67–1.67)
  • ED visit, hospitalization, or death by Day 14 in a prespecified secondary analysis: 23 (5.7%) in IVM arm vs. 16 (4.1%) in control arm (aOR 1.39; 95% CI, 0.72–2.69)
  • Hospitalization or death by Day 14 in a prespecified secondary analysis: 4 (1.0%) in IVM arm vs. 5 (1.3%) in control arm (aOR 0.73; 95% CI, 0.19–2.77); 1 death in IVM arm vs. 0 deaths in control arm

Secondary Outcomes

  • No difference between arms in total symptom severity score by Day 14
  • Drug discontinuation or interruption: 20% in IVM arm vs. 25% in placebo alone arm

Key Limitations

  • Study included SpO2 measurements using home pulse oximeters as 1 of the composite measures of the primary endpoint. However, the FDA has issued a statement concerning the accuracy of these home pulse oximeters, making this study endpoint less reliable.
  • SpO2 data were incomplete or missing for 30% of the patients.
  • The low number of events limited the power to determine the effect on hospitalization and death.

Interpretations

  • IVM did not prevent the composite endpoint of hypoxemia, ED visit, hospitalization, or death.
  • No primary, secondary, or subgroup analysis demonstrated a benefit for the use of IVM over placebo.
IVERCOR-COVID19: Double-Blind, Placebo-Controlled, Randomized Trial of Ivermectin in Nonhospitalized Patients With COVID-19 in Argentina31

Key Inclusion Criterion

  • Positive SARS-CoV-2 RT-PCR result within 48 hours of screening

Key Exclusion Criteria

  • Required supplemental oxygen or hospitalization
  • Concomitant use of CQ or HCQ

Interventions

  • Weight-based dose of IVM PO at enrollment and 24 hours later for a maximum total dose of 48 mg (n = 250)
  • Placebo (n = 251)

Primary Endpoint

  • Hospitalization for any reason

Key Secondary Endpoints

  • Need for MV
  • All-cause mortality
  • Occurrence of AEs

Participant Characteristics

  • Mean age 42 years; 8% aged ≥65 years; 47% women
  • 24% with HTN; 10% with DM; 58% with ≥1 comorbidity
  • Median of 4 days from symptom onset

Primary Outcome

  • Hospitalization for any reason: 5.6% in IVM arm vs. 8.3% in placebo arm (OR 0.65; 95% CI, 0.32–1.31; P = 0.23)

Secondary Outcomes

  • Need for MV: 2% in IVM arm vs. 1% in placebo arm (P = 0.7)
  • All-cause mortality: 2% in IVM arm vs. 1% in placebo arm (P = 0.7)
  • Occurrence of AEs: 18% in IVM arm vs. 21% in placebo arm (P = 0.6)

Key Limitation

  • Study enrolled a young population with few of the comorbidities that predict disease progression.

Interpretation

  • Among patients who had recently acquired SARS-CoV-2 infection, there was no evidence that IVM provided any clinical benefit.
Double-Blind, Placebo-Controlled, Randomized Trial of Ivermectin in Patients With Mild COVID-19 in Colombia32

Key Inclusion Criteria

  • Positive SARS-CoV-2 RT-PCR or antigen test result
  • ≤7 days of COVID-19 symptoms
  • Mild disease 

Key Exclusion Criteria

  • Asymptomatic disease
  • Severe pneumonia
  • Hepatic dysfunction

Interventions

  • IVM 300 μg/kg PO once daily for 5 days (n = 200)
  • Placebo PO (n = 198)

Primary Endpoint

  • Time to symptom resolution within 21 days 

Key Secondary Endpoints

  • Clinical deterioration
  • Escalation of care
  • Occurrence of AEs

Participant Characteristics

  • Median age 37 years; 4% aged ≥65 years in IVM arm, 8% in placebo arm; 39% men in IVM arm, 45% in placebo arm
  • 79% with no known comorbidities
  • Median of 5 days from symptom onset to randomization

Primary Outcome

  • Median time to symptom resolution: 10 days in IVM arm vs. 12 days in placebo arm (HR 1.07; P = 0.53)
    • Symptoms resolved by Day 21: 82% in IVM arm vs. 79% in placebo arm 

Secondary Outcomes

  • No difference between arms in proportion of patients who showed clinical deterioration or required escalation of care
  • Occurrence of AEs:
    • Discontinued treatment due to AEs: 8% in IVM arm vs. 3% in placebo arm 
    • No SAEs related to intervention

Key Limitations

  • Due to low event rates, the primary endpoint changed from the proportion of patients with clinical deterioration to the time to symptom resolution during the trial.
  • The study enrolled younger, healthier patients, a population that does not typically develop severe COVID-19.

Interpretation

  • In patients with mild COVID-19, IVM 300 μg/kg once daily for 5 days did not improve the time to symptom resolution.
I-TECH: Open-Label RCT of Ivermectin in Patients With Mild to Moderate COVID-19 in Malaysia33

Key Inclusion Criteria

  • Positive SARS-CoV-2 RT-PCR or antigen test result within 7 days of symptom onset
  • Aged ≥50 years 
  • ≥1 comorbidities

Key Exclusion Criteria

  • Required supplemental oxygen
  • Severe hepatic impairment (ALT >10 times the ULN)

Interventions

  • IVM 400 μg/kg PO once daily for 5 days plus SOC (n = 241)
  • SOC (n = 249)

Primary Endpoint

  • Progression to severe COVID-19 (i.e., hypoxemia requiring supplemental oxygen to maintain SpO2 ≥95%)

Key Secondary Endpoints

  • In-hospital, all-cause mortality by Day 28
  • MV or ICU admission
  • Occurrence of AEs

Participant Characteristics

  • Mean age 63 years; 55% women
  • 68% received ≥1 COVID-19 vaccine dose; 52% received 2 doses.
  • Most common comorbidities: 75% with HTN; 54% with DM; 24% with dyslipidemia
  • Mean of 5 days symptom duration

Primary Outcome

  • Progression to severe COVID-19 (mITT): 52 (21.6%) in IVM plus SOC arm vs. 43 (17.3%) in SOC alone arm (relative risk 1.25; 95% CI, 0.87–1.80; P = 0.25)

Secondary Outcomes

  • No difference between IVM plus SOC arm and SOC alone arm in:
    • In-hospital, all-cause mortality by Day 28: 3 (1.2%) vs. 10 (4.0%) (relative risk 0.31; 95% CI, 0.09–1.11; P = 0.09)
    • MV: 4 (1.7%) vs. 10 (4.0%) (relative risk 0.41; 95% CI, 0.13–1.30; P = 0.17)
    • ICU admission: 6 (2.5%) vs. 8 (3.2%) (relative risk 0.78; 95% CI, 0.27–2.20; P = 0.79)
  • Occurrence of AEs: 33 (13.7%) in IVM plus SOC arm vs. 11 (4.4%) in SOC alone arm; most with diarrhea (14 vs. 4)

Key Limitation

  • Open-label study

Interpretation

  • In patients with mild to moderate COVID-19, there was no evidence that IVM provided any clinical benefit, including no evidence that IVM reduced the risk of progression to severe disease. 
COVER: Phase 2, Double-Blind RCT of Ivermectin in Nonhospitalized Patients With COVID-19 in Italy34

Key Inclusion Criteria

  • Asymptomatic or oligosymptomatic disease
  • SARS-CoV-2 infection confirmed by RT-PCR result 
  • Not hospitalized or receiving supplemental oxygen

Key Exclusion Criteria

  • CNS disease
  • Receiving dialysis
  • Severe medical condition with <6 months survival prognosis
  • Use of warfarin, antiviral agents, CQ, or HCQ 

Interventions

  • IVM 1,200 μg/kg PO once daily for 5 days (n = 32)
  • IVM 600 μg/kg plus placebo PO once daily for 5 days (n = 29)
  • Placebo PO (n = 32)

Primary Endpoints

  • Number of SAEs
  • Change in VL at Day 7

Other Endpoint

  • Drug discontinuation or interruption

Participant Characteristics

  • Median age 47 years; 58% men
  • 86% with COVID-19 symptoms
  • 2.2% received a COVID-19 vaccine.

Primary Outcomes

  • No SAEs related to intervention 
  • Mean log10 reduction in VL at Day 7: 2.9 in IVM 1,200 μg/kg arm vs. 2.5 in IVM 600 μg/kg arm vs. 2.0 in placebo arm (IVM 1,200 μg/kg vs. placebo, P = 0.099; IVM 600 μg/kg vs. placebo, P = 0.122)

Other Outcomes

  • 14 (15.1%) discontinued treatment: 11 (34.4%) in IVM 1,200 μg/kg arm vs. 2 (6.9%) in IVM 600 μg/kg arm vs. 1 (3.1%) in placebo arm
  • All discontinuations in IVM 1,200 μg/kg arm were due to tolerability

Key Limitations

  • Small, Phase 2 study
  • 90% of subjects screened were not enrolled for various reasons.
  • Recruitment stopped early because of a decline in the number of COVID-19 cases.

Interpretations

  • A high dose of IVM (1,200 μg/kg) appears to be safe but not well tolerated; 34% of patients discontinued therapy due to AEs.
  • There was no significant difference in reduction of VL between IVM and placebo arms. 
Open-Label RCT of Ivermectin in Hospitalized Patients With COVID-19 in Egypt35

Key Inclusion Criteria

  • RT-PCR-confirmed SARS-CoV-2 infection by pharyngeal swab
  • Hospitalized with mild to moderate COVID-19

Key Exclusion Criterion

  • Cardiac problems

Interventions

  • IVM 12 mg PO once daily for 3 days (n = 82) 
  • SOC (n = 82)

Primary Endpoint

  • All-cause mortality by 28 days

Key Secondary Endpoints

  • Hospital LOS
  • Need for MV 

Participant Characteristics

  • Mean age 42 years for IVM arm, 39 years for SOC arm; 50% men
  • 49% with ≥1 comorbidities

Primary Outcome

  • All-cause mortality by 28 days: 3 (3.7%) in IVM arm vs. 4 (4.9%) in SOC arm (P = 1.00) 

Secondary Outcomes

  • Mean hospital LOS: 9 days in IVM arm vs. 11 days in SOC arm (P = 0.085) 
  • Need for MV: 3 (3.7%) in each arm (P = 1.00)

Key Limitation

  • Small, open-label study

Interpretation

  • The use of IVM did not reduce all-cause mortality, hospital LOS, or the need for MV among patients with mild to moderate COVID-19.
Double-Blind, Placebo-Controlled, Randomized Trial of Ivermectin in Patients With Mild to Moderate COVID-19 in India36

Key Inclusion Criteria

  • Positive SARS-CoV-2 RT-PCR or antigen test result
  • Hospitalized with mild to moderate COVID-19

Interventions

  • IVM 12 mg PO once daily for 2 days (n = 55)
  • Placebo PO (n = 57)

Primary Endpoint

  • Negative SARS-CoV-2 RT-PCR result on Day 6

Key Secondary Endpoints

  • Symptom resolution by Day 6
  • Discharge by Day 10
  • Need for ICU admission or MV
  • In-hospital mortality 

Participant Characteristics

  • Mean age 53 years; 28% women
  • 35% with HTN; 36% with DM
  • 79% with mild COVID-19
  • Mean of 6.9 days from symptom onset
  • 100% received HCQ, steroids, and antibiotics; 21% received RDV; 6% received tocilizumab.

Primary Outcome

  • Negative SARS-CoV-2 RT-PCR result on Day 6: 24% in IVM arm vs. 32% in placebo arm (rate ratio 0.8; P = 0.348)

Secondary Outcomes

  • Symptom resolution by Day 6: 84% in IVM arm vs. 90% in placebo arm (rate ratio 0.9; P = 0.36)
  • Discharge by Day 10: 80% in IVM arm vs. 74% in placebo arm (rate ratio 1.1; P = 0.43)
  • No difference between arms in need for ICU admission or MV
  • In-hospital mortality: 0 in IVM arm (0%) vs. 4 in placebo arm (7%)

Key Limitations

  • Although the primary endpoint was a negative SARS-CoV-2 RT-PCR result on Day 6, no RT-PCR result or an inconclusive RT-PCR result was reported for 42% of patients in the IVM arm and 23% in the placebo arm.
  • The time to discharge was not reported, and outcomes after discharge were not evaluated.

Interpretation

  • IVM provided no significant virologic or clinical benefit for patients with mild to moderate COVID-19.
RIVET-COV: Double-Blind, Placebo-Controlled, Randomized Trial of Ivermectin in Patients With Mild to Moderate COVID-19 in India37

Key Inclusion Criteria

  • Positive SARS-CoV-2 RT-PCR or antigen test result
  • Nonsevere COVID-19

Key Exclusion Criteria

  • CrCl <30 mL/min
  • Transaminases >5 times ULN
  • MI, heart failure, QTc interval prolongation
  • Severe comorbidity

Interventions

  • Single dose of IVM 24 mg PO (n = 51)
  • Single dose of IVM 12 mg PO (n = 49)
  • Placebo (n = 52)

Primary Endpoints

  • Negative SARS-CoV-2 RT-PCR result at Day 5
  • Decline of VL at Day 5

Key Secondary Endpoints

  • Time to symptom resolution
  • Clinical worsening at Day 14
  • Number of hospital-free days at Day 28
  • Frequency of AEs

Participant Characteristics

  • Mean age 35 years; 89% men
  • 60% to 68% with mild COVID-19 (including asymptomatic patients); 33% to 40% with moderate COVID-19
  • Median of 4–5 days symptom duration; similar across arms
  • 10% in each arm received concurrent antivirals (RDV, favipiravir, or HCQ).

Primary Outcomes

  • Negative SARS-CoV-2 RT-PCR result at Day 5: 48% in IVM 24 mg arm vs. 35% in IVM 12 mg arm vs. 31% in placebo arm (P = 0.30)
  • No significant difference between arms in decline of VL at Day 5

Secondary Outcomes 

  • No difference between arms in time to symptom resolution
  • Clinical worsening at Day 14: 8% in IVM 24 mg arm vs. 5% in IVM 12 mg arm vs. 11% in placebo arm (P = 0.65)
  • No difference between arms in number of hospital-free days at Day 28
  • No difference between arms in frequency of AEs; no SAEs were reported

Key Limitation

  • Small sample size

Interpretation

  • The use of IVM did not affect the proportion of patients with negative SARS-CoV-2 RT-PCR results at Day 5 or the clinical outcomes.
Double-Blind RCT of Ivermectin, Chloroquine, or Hydroxychloroquine in Hospitalized Adults With Severe COVID-19 in Brazil38

Key Inclusion Criteria

  • Hospitalized with laboratory-confirmed SARS-CoV-2 infection
  • ≥1 of the following severity criteria: 
    • Dyspnea 
    • Tachypnea (>30 breaths/min) 
    • SpO2 <93%
    • PaO2/FiO2 <300 mm Hg 
    • Involvement of >50% of lungs confirmed by CXR or CT scan

Key Exclusion Criterion

  • Cardiac arrhythmia

Interventions

  • IVM 14 mg once daily for 3 days (n = 53)
  • CQ 450 mg twice daily on Day 0, then once daily for 4 days (n = 61)
  • HCQ 400 mg twice daily on Day 0, then once daily for 4 days (n = 54)

Endpoints

  • Need for supplemental oxygen, MV, or ICU admission 
  • Occurrence of AEs
  • Mortality

Participant Characteristics

  • Mean age 53 years; 58% men
  • Most common comorbidities: 43% with HTN; 28% with DM; 38% with BMI >30
  • 76% with respiratory failure on admission

Outcomes

  • No difference between IVM, CQ, and HCQ arms in:
    • Need for supplemental oxygen: 88% vs. 89% vs. 90%
    • Need for MV: 24% vs. 21% vs. 21%
    • ICU admission: 28% vs. 22% vs. 21%
    • Mortality: 23% vs. 21% vs. 22%
    • Mean number of days of supplemental oxygen: 8 days in each arm
  • No difference between arms in occurrence of AEs
  • Baseline characteristics significantly associated with mortality:
    • Aged >60 years (HR 2.4)
    • DM (HR 1.9)
    • BMI >33 (HR 2.0)
    • SpO2 <90% (HR 5.8)

Key Limitations

  • Small sample size
  • No clearly defined primary endpoint

Interpretation

  • Compared to CQ or HCQ, IVM did not reduce the proportion of hospitalized patients with severe COVID-19 who died or who required supplemental oxygen, ICU admission, or MV.

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