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Table 2d. Ivermectin: Selected Clinical Data

Last Updated: April 29, 2022

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 2d. Ivermectin: Selected Clinical Data
Methods Results Limitations and Interpretation
TOGETHER: Double-Blind, Adaptive, RCT of Ivermectin in Nonhospitalized Patients With COVID-19 in Brazil27

Key Inclusion Criteria:

  • Positive SARS-CoV-2 antigen test
  • 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 per day for 3 days (n = 679)
  • Placebo (n = 679; not all participants received IVM placebo)

Primary Endpoint:

  • Composite of emergency setting observation >6 hours or hospitalized for COVID-19 within 28 days of randomization

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% “mixed race”
  • Most prevalent risk factor: 50% with obesity
  • Symptom onset: 44% within 3 days

Primary Outcome:

  • Composite of emergency setting observation >6 hours or hospitalized within 28 days of randomization (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 all events were hospitalizations (ITT)

Secondary Outcomes:

  • No difference between IVM and placebo arms 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 emergency setting 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 COVID-19 infection, IVM did not reduce the need for emergency setting visits or hospitalization when compared with placebo.
IVERCOR-COVID19: Double-Blind, Placebo-Controlled, Randomized Trial of Ivermectin in Nonhospitalized Patients With COVID-19 in Argentina28

Key Inclusion Criterion:

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

Key Exclusion Criteria:

  • Oxygen supplementation 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 time from symptom onset: 4 days

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:

  • Enrolled a fairly 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.
I-TECH: Open-Label RCT of Ivermectin in Patients With Mild to Moderate COVID-19 in Malaysia29

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Interventions:

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

Primary Endpoint:

  • Progression to severe COVID-19 (i.e., hypoxia 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 dose COVID-19 vaccine; 52% received 2 doses
  • Most common comorbidities: 75% with HTN; 54% with DM; 24% with dyslipidemia
  • Mean duration of symptoms: 5 days

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: 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 the IVM plus SOC arm vs. 11 (4.4%) in the 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 progression to severe disease.
Double-Blind, Placebo-Controlled, Randomized Trial of Ivermectin in Patients With Mild COVID-19 in Colombia30

Key Inclusion Criteria:

  • Positive SARS-CoV-2 RT-PCR or antigen test result
  • Symptoms ≤7 days
  • Mild disease

Key Exclusion Criteria:

  • Asymptomatic disease
  • Severe pneumonia
  • Hepatic dysfunction

Interventions:

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

Primary Endpoint:

  • Time to resolution of symptoms 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 symptom onset to randomization: 5 days

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:

  • Clinical deterioration: no difference between arms
  • Escalation of care: no difference between arms
  • Occurrence of AEs:
    • Discontinued treatment due to AEs: 8% in IVM arm vs. 3% in placebo arm
    • No SAEs were 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 per day for 5 days did not improve the time to resolution of symptoms.
Open-Label RCT of Ivermectin in Hospitalized Patients With COVID-19 in Egypt31

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 comorbidity

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:

  • Use of IVM, when compared with the SOC, did not result in differences in all-cause mortality, hospital LOS, or the need for MV.
Double-Blind, Placebo-Controlled, Randomized Trial of Ivermectin in Patients With Mild to Moderate COVID-19 in India32

Key Inclusion Criteria:

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

Interventions:

  • IVM 12 mg PO 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 6.9 days from symptom onset
  • 100% received HCQ, steroids, and antibiotics; 21% received RDV; 6% received tocilizumab

Primary Outcome:

  • Negative 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)
  • Need for ICU admission or MV: no difference between arms
  • 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 India33

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 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 duration of symptoms: 4–5 days, similar across arms
  • 10% received concurrent antivirals (RDV, favipiravir, or HCQ); no difference across arms

Primary Outcomes:

  • Negative 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)
  • Decline of VL at Day 5: no significant difference between arms

Secondary Outcomes:

  • Time to symptom resolution: no difference between arms
  • 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)
  • Number of hospital-free days at Day 28: no difference between arms
  • Frequency of AEs: no difference between arms; no SAEs

Key Limitation:

  • Small sample size

Interpretation:

  • For patients who received IVM and those who received placebo, there was no difference in the proportion of negative RT-PCR results at Day 5 or clinical outcomes.
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

Participant Characteristics:

  • Median age 47 years; 58% men
  • 86% with symptoms

Primary Outcomes:

  • Number of SAEs: 0
  • 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)

AE 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 due to tolerability

Key Limitations:

  • Small, Phase 2 study
  • 90% of subjects screened were not enrolled for various reasons.
  • Recruitment stopped early because of 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% discontinued therapy due to AEs.
  • There was no significant difference in reduction of VL between IVM and placebo arms.
Double-Blind RCT of Ivermectin, Chloroquine, or Hydroxychloroquine in Hospitalized Adults With Severe COVID-19 in Brazil35

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 by CXR or CT

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%
    • ICU admission: 28% vs. 22% vs. 21%
    • Need for MV: 24% vs. 21% vs. 21%
    • Mortality: 23% vs. 21% vs. 22%
    • Mean number of days of supplemental oxygen: 8 days for each arm
  • Occurrence of AEs: no difference between arms
  • 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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