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Table 2d. Ivermectin: Selected Clinical Data

Last Updated: December 16, 2021

The Panel has 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 discussed below. The studies summarized below are the randomized controlled trials that have had the greatest impact on the Panel’s recommendations.

Table 2d. Ivermectin: Selected Clinical Data
Methods Results Limitations and Interpretation
IVERCOR-COVID19: Double-Blind, Placebo-Controlled RCT of Ivermectin to Prevent Hospitalizations in Patients With COVID-19 in Argentina27
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 doses of IVM given 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

Participant Characteristics:

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

Primary Outcome:

  • COVID-19-related hospitalizations: 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 deaths: 2% in IVM arm vs. 1% in placebo arm (P = 0.7)
  • AEs: 18% in IVM arm vs. 21% in placebo arm (P = 0.6)
Key Limitation:
  • Study enrolled a fairly young population with few comorbidities that predict disease progression

Interpretation:

  • In patients who had recently acquired SARS-CoV-2 infection, there was no evidence of a clinical benefit for IVM.
Double-Blind, Placebo-Controlled RCT of Ivermectin for Treatment of Mild COVID-19 in Columbia28
Key Inclusion Criteria:
  • Positive SARS-CoV-2 PCR or antigen test result
  • Symptoms for ≤7 days
  • Mild disease

Key Exclusion Criteria:

  • Asymptomatic disease
  • Severe pneumonia
  • Hepatic dysfunction

Interventions:

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

Primary Endpoint:

  • Time to resolution of symptoms within 21 days

Key Secondary Endpoint:

  • Proportion of patients with clinical deterioration
  • Proportion of patients who required escalation in care

Participant Characteristics:

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

Primary Outcomes:

  • 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 had clinical deterioration or who required escalation in care.

Safety Outcomes:

  • Discontinued treatment due to an AE: 8% in IVM arm vs. 3% in placebo arm
  • No SAEs were considered to be related to study interventions.
Key Limitations:
  • Primary endpoint changed from proportion of patients with clinical deterioration to time to symptom resolution during the trial due to low event rates
  • Study enrolled younger, healthier patients; this population does not typically develop severe COVID-19

Interpretation:

  • A 5-day course of IVM 300 μg/kg per day did not improve the time to resolution of symptoms in patients with mild COVID-19.
Open-Label RCT of Ivermectin Plus Doxycycline Versus Hydroxychloroquine Plus Azithromycin for Asymptomatic Patients and Patients With Mild to Moderate COVID-19 in Bangladesh29
Key Inclusion Criteria:
  • Aged 16–80 years
  • PCR-confirmed SARS-CoV-2 infection
  • SpO2 ≥95%
  • Normal or near-normal CXR
  • No unstable comorbidities

Interventions:

  • Single dose of IVM 200 μg/kg plus DOX 100 mg twice daily for 10 days (n = 60)
  • HCQ 400 mg on Day 1, then HCQ 200 mg twice daily for 9 days plus AZM 500 mg once daily for 5 days (n = 56)

Primary Endpoints:

  • Time to negative PCR result
  • Time to resolution of symptoms

Participant Characteristics:

  • Mean age 34 years; 78% were men
  • 78% were symptomatic at baseline

Primary Outcomes:

  • Mean time to negative PCR result: 9 days in both arms
  • In patients who were symptomatic at baseline, mean time to negative PCR result: 9 days in IVM/DOX arm vs. 10 days in HCQ/AZM arm (P = 0.07)
  • Mean time to symptom recovery: 6 days in IVM/DOX arm vs. 7 days in HCQ/AZM arm (P = 0.07)
  • Patients who received IVM/DOX had fewer AEs than those who received HCQ/AZM (32% vs. 46%).
Key Limitations:
  • Small sample size
  • Open-label study
  • No SOC alone group
  • Study enrolled young patients who were not at high risk for disease progression

Interpretation:

  • There was no difference in the time to a negative SARS-CoV-2 PCR result or symptom recovery between patients who received IVM plus DOX and those who received HCQ plus AZM.
Double-Blind, Placebo-Controlled RCT of Ivermectin for Treatment of Mild to Moderate COVID-19 in India30
Key Inclusion Criteria:
  • Positive SARS-CoV-2 RT-PCR or antigen test result
  • Hospitalized with mild or moderate COVID-19

Interventions:

  • IVM 12 mg for 2 days (n = 55)
  • Placebo (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
  • Mortality

Participant Characteristics:

  • Mean age 53 years; 28% were 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 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 (RR 1.1; P = 0.43)
  • No difference between arms in proportion of patients who were admitted to ICU or who required MV.
  • Inpatient deaths: 0 in IVM arm (0%) vs. 4 in placebo arm (7%)
Key Limitations:
  • The primary endpoint of the study was a negative SARS-CoV-2 RT-PCR result on Day 6. However, the study reported no RT-PCR result or an inconclusive RT-PCR result for 42% of patients in the IVM arm and 23% in the placebo arm.
  • Time to discharge was not reported and outcomes after discharge were not evaluated

Interpretation:

  • There was no significant virologic or clinical benefit of IVM for patients with mild to moderate COVID-19.
RIVET-COV: Double-Blind, Placebo-Controlled RCT of Ivermectin in Patients With Mild to Moderate COVID-19 in India31
Key Inclusion Criteria:
  • Positive SARS-CoV-2 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 (n = 51)
  • Single dose of IVM 12 mg (n = 49)
  • Placebo (n = 52)

Primary Endpoints:

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

Key Secondary Endpoints:

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

Participant Characteristics:

  • Mean age 35 years; 89% were men
  • 60% to 68% had mild COVID-19 (including asymptomatic patients); 33% to 40% had moderate COVID-19
  • Median duration of symptoms was similar between arms (4–5 days).
  • 10% received concurrent antivirals (RDV, favipiravir, or HCQ); no difference between arms.

Primary Outcomes:

  • Proportion with negative PCR result on Day 5: 48% in IVM 24 mg arm vs. 35% in IVM 12 mg arm vs. 31% in placebo arm (P = 0.30)
  • VL at enrollment did not impact conversion to negative RT-PCR on Day 5.
  • No significant difference between arms in VL decline by Day 5.

Secondary Outcomes:

  • No difference between arms in time to symptom resolution or number of hospital-free days at Day 28.
  • Proportion with clinical worsening similar across arms: 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 frequency of AEs.
  • No SAEs reported.
Key Limitation:
  • Small sample size

Interpretation:

  • There was no difference in the rate of negative PCR results on Day 5 or clinical outcomes between patients who received IVM and those who received placebo.
Double-Blind RCT of Ivermectin, Chloroquine, or Hydroxychloroquine in Hospitalized Adults With Severe COVID-19 in Brazil32
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 on 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
  • Mortality

Participant Characteristics:

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

Outcomes:

  • No difference between IVM, CQ, and HCQ arms in:
    • Proportion requiring 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
  • No difference in proportion of patients with AEs between the arms.
  • Baseline characteristics that were 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 placebo control
  • 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 required supplemental oxygen, ICU admission, or MV or the proportion of patients who died.
Double-Blind RCT of Ivermectin as Adjunctive Therapy in Hospitalized Patients With Mild to Severe COVID-19 in Iran33
Key Inclusion Criterion:
  • Symptoms suggestive of COVID-19 pneumonia, with compatible chest CT scan or positive SARS-CoV-2 PCR result

Key Exclusion Criterion:

  • Severe immunosuppression, malignancy, or chronic kidney disease

Interventions:

  • HCQ 200 mg twice daily as SOC plus 1 of the following:
    • SOC alone (n = 30)
    • Placebo (n = 30)
    • Single dose of IVM 200 μg/kg (n = 30)
    • IVM 200 μg/kg on Days 1, 3, and 5 (n = 30)
    • Single dose of IVM 400 μg/kg (n = 30)
    • IVM 400 μg/kg on Day 1, then IVM 200 μg/kg on Days 3 and 5 (n = 30)

Primary Endpoints:

  • Clinical recovery
  • All-cause mortality

Participant Characteristics:

  • Median age 53–61 years across arms; 50% were men
  • Disease severity stratification (based on CT findings): negative (1%), mild (14%), moderate (73%), severe (12%)
  • Median SpO2 at baseline was 88% to 91% across arms
  • Proportion of patients in each arm with a positive SARS-CoV-2 PCR result varied, with a range of 47% to 97%

Primary Outcomes:

  • Median duration of hypoxemia was shorter in IVM arms than in placebo arm (P = 0.025).
  • Median duration of hospitalization was shorter in IVM arms than in placebo arm (P = 0.006).
  • No difference between the arms in number of days of tachypnea or number of days to return to normal temperature.
  • Mortality was higher in SOC and placebo arms (18%) than in IVM arms (3%; P < 0.001).
Key Limitations:
  • Since IVM was given as a single dose or multiple doses and no placebo was given to patients in these arms, the study was not truly blinded
  • Large proportion of patients did not have laboratory-confirmed SARS-CoV-2 infection, and there was an imbalance across arms in the proportion of patients with laboratory-confirmed SARS-CoV-2 infection
  • Concerns have been raised about whether the study was conducted as reported34
  • Post hoc grouping of randomized arms raises risk of false positive findings

Interpretation:

  • The unclear treatment arm assignments and the lack of accounting for disease severity at baseline make it difficult to draw conclusions about the efficacy of using IVM to treat mild COVID-19.

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