Table 7b.

Ivermectin: Selected Clinical Trial Data

Last Updated: December 20, 2023

The clinical trials described in this table are the RCTs that had the greatest impact on the Panel’s recommendation. The Panel reviewed other
clinical studies that evaluated the use 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 this table.

Methods Results Limitations and Interpretation

ACTIV-6: Double-Blind RCT of Ivermectin 600 μg/kg in Outpatients With Mild to Moderate COVID-19 in the United States27
Key Inclusion Criteria Participant Characteristics Key Limitation
• Aged ≥30 years • Median age 48 years; 59.1% women • The low number of events limited
• Not hospitalized • 38.1% with BMI >30; 9.2% with DM; 26.8% with HTN the power to determine an effect on
hospitalization and death.
• Positive SARS-CoV-2 test result within past 10 days • 83.6% received ≥2 COVID-19 vaccine doses.
• ≥2 COVID-19 symptoms for ≤7 days • Median of 5 days from symptom onset to receipt of Interpretation
study drug • Among outpatients with COVID-19, IVM
Key Exclusion Criteria 600 μg/kg PO once daily for 6 days did
• End-stage kidney disease Primary Outcome not shorten time to sustained recovery
• Liver failure or decompensated cirrhosis • Median time to sustained recovery: 11 days in IVM arm or reduce incidence of hospitalization or
vs. 11 days in placebo arm (HR 1.02; 95% CrI, 0.92– death.
Interventions 1.13)
• IVM 600 μg/kg PO once daily for 6 days (n = 602) Secondary Outcome
• Placebo (n = 604) • Hospitalization or death by Day 28: 5 (0.8%) in IVM arm
Primary Endpoint vs. 2 (0.3%) in placebo arm
• Time to sustained recovery (i.e., ≥3 consecutive days Safety Outcomes
without symptoms) • Occurrence of AEs: 52 of 566 patients (9.2%) in IVM arm
Key Secondary Endpoint vs. 41 of 576 patients (7.1%) in placebo arm
• Hospitalization or death by Day 28 • Occurrence of SAEs: 5 of 566 patients (0.9%) in IVM arm
vs. 3 of 576 patients (0.5%) in placebo arm
Safety Endpoint
• Occurrence of AEs and SAEs

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 Methods Results Limitations and Interpretation

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 Participant Characteristics Key Limitation
• Aged ≥30 years • Mean age 48 years; 59% women • The low number of events limited
• Not hospitalized • 41% with BMI >30; 11.5% with DM; 26% with HTN the power to determine an effect on
hospitalization and death.
• Positive SARS-CoV-2 test result within past 10 days • 47% received ≥2 COVID-19 vaccine doses.
• ≥2 COVID-19 symptoms for ≤7 days • Median of 6 days from symptom onset to receipt of study Interpretation
drug • Among outpatients with COVID-19, IVM
Key Exclusion Criteria 400 μg/kg PO once daily for 3 days did
• End-stage kidney disease Primary Outcome not shorten time to sustained recovery
• Liver failure or decompensated cirrhosis • Median time to sustained recovery: 12 days in IVM arm or reduce incidence of hospitalization or
vs. 13 days in placebo arm (HR 1.07; 95% CrI, 0.96– death.
Interventions 1.17)
• IVM 400 μg/kg PO once daily for 3 days (n = 817) Secondary Outcome
• Placebo (n = 774) • Hospitalization or death by Day 28: 10 (1.2%) in IVM arm
Primary Endpoint vs. 9 (1.2%) in placebo arm
• Time to sustained recovery (i.e., ≥3 consecutive days Safety Outcomes
without symptoms) • Occurrence of AEs: 24 of 766 patients (3.1%) in IVM arm
Key Secondary Endpoint vs. 27 of 724 patients (3.7%) in placebo arm
• Hospitalization or death by Day 28 • Occurrence of SAEs: 9 of 766 patients (1.2%) in IVM arm
vs. 9 of 724 patients (1.2%) in placebo arm
Safety Endpoint
• Occurrence of AEs and SAEs

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 Methods Results Limitations and Interpretation

TOGETHER: Double-Blind, Adaptive RCT of Ivermectin in Nonhospitalized Patients With COVID-19 in Brazil29
Key Inclusion Criteria Participant Characteristics Key Limitations
• Positive SARS-CoV-2 antigen test result • Median age 49 years; 46% aged ≥50 years; 58% • Health care facility capacity may have
• Within 7 days of symptom onset women; 95% self-identified as mixed race influenced the number and duration of
• Most prevalent risk factor: 50% with obesity ED visits and hospitalizations.
• ≥1 high-risk factor for disease progression (e.g., aged
>50 years, comorbidities, immunosuppression) • 44% within 3 days of symptom onset at enrollment • No details on safety outcomes (e.g., type
of treatment-emergent AEs) other than
Interventions Primary Outcome grading were reported.
• IVM 400 μg/kg PO once daily for 3 days (n = 679) • Composite of ED observation >6 hours or hospitalization Interpretation
• Placebo (n = 679; not all patients received IVM placebo) 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, • In outpatients with recent SARS-CoV-2
Primary Endpoint 0.70–1.16) infection, IVM did not reduce the need
• Composite of ED observation >6 hours or hospitalization for ED visits or hospitalization when
• 171 (81%) of events were hospitalizations (ITT) compared with placebo.
for COVID-19 by Day 28
Secondary Outcomes
Key Secondary Endpoints
• No difference between IVM arm and placebo arm in:
• Viral clearance at Day 7
• Viral clearance at Day 7 (relative risk 1.00; 95% CrI,
• All-cause mortality 0.68–1.46)
• Occurrence of AEs • All-cause mortality: 21 (3.1%) vs. 24 (3.5%) (relative
risk 0.88; CrI, 0.49–1.55)
• Occurrence of AEs

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 Methods Results Limitations and Interpretation

COVID-OUT: RCT of Metformin, Ivermectin, and Fluvoxamine in Nonhospitalized Adults With COVID-19 in the United States30
Key Inclusion Criteria Participant Characteristics Key Limitations
• Aged 30–85 years • Median age 46 years; 56% women; 82% White • Study included SpO2 measurements
• BMI ≥25 or ≥23 if Asian or Latinx • Median BMI 30 using home pulse oximeters as 1 of
the composite measures of the primary
• Laboratory-confirmed SARS-CoV-2 infection within 3 days • 27% with CVD endpoint. However, the FDA has issued
of randomization • 52% received primary COVID-19 vaccination series. a statement concerning the accuracy
• ≤7 days of COVID-19 symptoms • Mean of 4.8 days of symptoms of these home pulse oximeters, making
Key Exclusion Criteria this study endpoint less reliable.
• Approximately 68% enrolled while Delta was the
• Immunocompromised dominant variant; approximately 29% enrolled while • SpO2 data were incomplete or missing
Omicron was dominant. for 30% of the patients.
• Hepatic impairment
Primary Outcomes • The low number of events limited
• Stage 4–5 chronic kidney disease or eGFR <45 mL/ the power to determine the effect on
min/1.73 m² • Composite of hypoxemia, ED visit, hospitalization, or hospitalization and death.
death by Day 14: 105 (25.8%) in IVM arm vs. 96 (24.6%)
Interventions Interpretations
in control arm (aOR 1.05; 95% CI, 0.76–1.45, P = 0.78)
• IVM 390–470 ug/kg PO once daily for 3 days (n = 410) in • IVM did not prevent the composite
• No difference between IVM alone arm and placebo alone
the following arms: endpoint of hypoxemia, ED visit,
arm in occurrence of primary endpoint (aOR 1.06; 95%
• IVM alone (n = 206) CI, 0.67–1.67) hospitalization, or death.
• Metformin plus IVM (n = 204) • ED visit, hospitalization, or death by Day 14 in a • No primary, secondary, or subgroup
• IVM control (n = 398), which included the following arms: prespecified secondary analysis: 23 (5.7%) in IVM arm analysis demonstrated a benefit for the
vs. 16 (4.1%) in control arm (aOR 1.39; 95% CI, 0.72– use of IVM over placebo.
• Placebo alone (n = 203)
2.69)
• Metformin alone (n = 195)
• Hospitalization or death by Day 14 in a prespecified
Primary Endpoints secondary analysis: 4 (1.0%) in IVM arm vs. 5 (1.3%) in
• Composite of hypoxemia (SpO2 ≤93%, as measured by a control arm (aOR 0.73; 95% CI, 0.19–2.77); 1 death in
home pulse oximeter), ED visit, hospitalization, or death IVM arm vs. 0 deaths in control arm
by Day 14 Secondary Outcomes
• A prespecified secondary analysis evaluated the • No difference between arms in total symptom severity
occurrence of ED visits, hospitalization, or death by Day score by Day 14
14.
• Drug discontinuation or interruption: 20% in IVM arm vs.
Key Secondary Endpoints 25% in placebo alone arm
• Total symptom severity score by Day 14, as measured by
a symptom severity scale
• Drug discontinuation or interruption

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 Methods Results Limitations and Interpretation

IVERCOR-COVID19: Double-Blind, Placebo-Controlled, Randomized Trial of Ivermectin in Nonhospitalized Patients With COVID-19 in Argentina31
Key Inclusion Criterion Participant Characteristics Key Limitation
• Positive SARS-CoV-2 RT-PCR result within 48 hours of • Mean age 42 years; 8% aged ≥65 years; 47% women • Study enrolled a young population with
screening • 24% with HTN; 10% with DM; 58% with ≥1 comorbidity few of the comorbidities that predict
disease progression.
Key Exclusion Criteria • Median of 4 days from symptom onset
• Required supplemental oxygen or hospitalization Interpretation
Primary Outcome
• Concomitant use of CQ or HCQ • Among patients who had recently
• Hospitalization for any reason: 5.6% in IVM arm vs. 8.3% acquired SARS-CoV-2 infection, there
Interventions in placebo arm (OR 0.65; 95% CI, 0.32–1.31; P = 0.23) was no evidence that IVM provided any
• Weight-based dose of IVM PO at enrollment and 24 Secondary Outcomes clinical benefit.
hours later for a maximum total dose of 48 mg (n = • Need for MV: 2% in IVM arm vs. 1% in placebo arm (P =
250) 0.7)
• Placebo (n = 251) • All-cause mortality: 2% in IVM arm vs. 1% in placebo
Primary Endpoint arm (P = 0.7)
• Hospitalization for any reason • Occurrence of AEs: 18% in IVM arm vs. 21% in placebo
arm (P = 0.6)
Key Secondary Endpoints
• Need for MV
• All-cause mortality
• Occurrence of AEs

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 Methods Results Limitations and Interpretation

Double-Blind, Placebo-Controlled, Randomized Trial of Ivermectin in Patients With Mild COVID-19 in Colombia32
Key Inclusion Criteria Participant Characteristics Key Limitations
• Positive SARS-CoV-2 RT-PCR or antigen test result • Median age 37 years; 4% aged ≥65 years in IVM arm, 8% • Due to low event rates, the primary
• ≤7 days of COVID-19 symptoms in placebo arm; 39% men in IVM arm, 45% in placebo endpoint changed from the proportion of
arm patients with clinical deterioration to the
• Mild disease time to symptom resolution during the
• 79% with no known comorbidities
Key Exclusion Criteria trial.
• Median of 5 days from symptom onset to randomization
• Asymptomatic disease • The study enrolled younger, healthier
Primary Outcome patients, a population that does not
• Severe pneumonia
• Median time to symptom resolution: 10 days in IVM arm typically develop severe COVID-19.
• Hepatic dysfunction vs. 12 days in placebo arm (HR 1.07; P = 0.53) Interpretation
Interventions • Symptoms resolved by Day 21: 82% in IVM arm vs. • In patients with mild COVID-19, IVM
• IVM 300 μg/kg PO once daily for 5 days (n = 200) 79% in placebo arm 300 μg/kg once daily for 5 days did not
• Placebo PO (n = 198) Secondary Outcomes improve the time to symptom resolution.
Primary Endpoint • No difference between arms in proportion of patients who
• Time to symptom resolution within 21 days showed clinical deterioration or required escalation of
care
Key Secondary Endpoints • Occurrence of AEs:
• Clinical deterioration • Discontinued treatment due to AEs: 8% in IVM arm vs.
• Escalation of care 3% in placebo arm
• Occurrence of AEs • No SAEs related to intervention

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 Methods Results Limitations and Interpretation

I-TECH: Open-Label RCT of Ivermectin in Patients With Mild to Moderate COVID-19 in Malaysia33
Key Inclusion Criteria Participant Characteristics Key Limitation
• Positive SARS-CoV-2 RT-PCR or antigen test result • Mean age 63 years; 55% women • Open-label study
within 7 days of symptom onset • 68% received ≥1 COVID-19 vaccine dose; 52% received Interpretation
• Aged ≥50 years 2 doses.
• In patients with mild to moderate
• ≥1 comorbidities • Most common comorbidities: 75% with HTN; 54% with COVID-19, there was no evidence
DM; 24% with dyslipidemia that IVM provided any clinical benefit,
Key Exclusion Criteria
• Mean of 5 days symptom duration including no evidence that IVM reduced
• Required supplemental oxygen the risk of progression to severe disease.
• Severe hepatic impairment (ALT >10 times the ULN) Primary Outcome
• Progression to severe COVID-19 (mITT): 52 (21.6%)
Interventions
in IVM plus SOC arm vs. 43 (17.3%) in SOC alone arm
• IVM 400 μg/kg PO once daily for 5 days plus SOC (n = (relative risk 1.25; 95% CI, 0.87–1.80; P = 0.25)
241)
Secondary Outcomes
• SOC (n = 249)
• No difference between IVM plus SOC arm and SOC alone
Primary Endpoint arm in:
• Progression to severe COVID-19 (i.e., hypoxemia • In-hospital, all-cause mortality by Day 28: 3 (1.2%) vs.
requiring supplemental oxygen to maintain SpO2 ≥95%) 10 (4.0%) (relative risk 0.31; 95% CI, 0.09–1.11; P =
Key Secondary Endpoints 0.09)
• In-hospital, all-cause mortality by Day 28 • MV: 4 (1.7%) vs. 10 (4.0%) (relative risk 0.41; 95% CI,
0.13–1.30; P = 0.17)
• MV or ICU admission
• ICU admission: 6 (2.5%) vs. 8 (3.2%) (relative risk 0.78;
• Occurrence of AEs 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)

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 Methods Results Limitations and Interpretation

COVER: Phase 2, Double-Blind RCT of Ivermectin in Nonhospitalized Patients With COVID-19 in Italy34
Key Inclusion Criteria Participant Characteristics Key Limitations
• Asymptomatic or oligosymptomatic disease • Median age 47 years; 58% men • Small, Phase 2 study
• SARS-CoV-2 infection confirmed by RT-PCR result • 86% with COVID-19 symptoms • 90% of subjects screened were not
• Not hospitalized or receiving supplemental oxygen • 2.2% received a COVID-19 vaccine. enrolled for various reasons.
• Recruitment stopped early because of a
Key Exclusion Criteria Primary Outcomes
decline in the number of COVID-19 cases.
• CNS disease • No SAEs related to intervention
Interpretations
• Receiving dialysis • 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 • A high dose of IVM (1,200 μg/kg) appears
• Severe medical condition with <6 months survival to be safe but not well tolerated; 34% of
prognosis arm (IVM 1,200 μg/kg vs. placebo, P = 0.099; IVM 600
μg/kg vs. placebo, P = 0.122) patients discontinued therapy due to AEs.
• Use of warfarin, antiviral agents, CQ, or HCQ • There was no significant difference in
Other Outcomes
Interventions reduction of VL between IVM and placebo
• 14 (15.1%) discontinued treatment: 11 (34.4%) in IVM arms.
• IVM 1,200 μg/kg PO once daily for 5 days (n = 32) 1,200 μg/kg arm vs. 2 (6.9%) in IVM 600 μg/kg arm vs. 1
• IVM 600 μg/kg plus placebo PO once daily for 5 days (n (3.1%) in placebo arm
= 29) • All discontinuations in IVM 1,200 μg/kg arm were due to
• Placebo PO (n = 32) tolerability
Primary Endpoints
• Number of SAEs
• Change in VL at Day 7
Other Endpoint
• Drug discontinuation or interruption

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 Methods Results Limitations and Interpretation

Open-Label RCT of Ivermectin in Hospitalized Patients With COVID-19 in Egypt35

Key Inclusion Criteria Participant Characteristics Key Limitation
• RT-PCR-confirmed SARS-CoV-2 infection by pharyngeal • Mean age 42 years for IVM arm, 39 years for SOC arm; • Small, open-label study
swab 50% men
Interpretation
• Hospitalized with mild to moderate COVID-19 • 49% with ≥1 comorbidities
• The use of IVM did not reduce all-cause
Key Exclusion Criterion Primary Outcome mortality, hospital LOS, or the need
• Cardiac problems • All-cause mortality by 28 days: 3 (3.7%) in IVM arm vs. 4 for MV among patients with mild to
(4.9%) in SOC arm (P = 1.00) moderate COVID-19.
Interventions
• IVM 12 mg PO once daily for 3 days (n = 82) Secondary Outcomes
• SOC (n = 82) • Mean hospital LOS: 9 days in IVM arm vs. 11 days in SOC
arm (P = 0.085)
Primary Endpoint
• Need for MV: 3 (3.7%) in each arm (P = 1.00)
• All-cause mortality by 28 days
Key Secondary Endpoints
• Hospital LOS
• Need for MV

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 Methods Results Limitations and Interpretation

Double-Blind, Placebo-Controlled, Randomized Trial of Ivermectin in Patients With Mild to Moderate COVID-19 in India36
Key Inclusion Criteria Participant Characteristics Key Limitations
• Positive SARS-CoV-2 RT-PCR or antigen test result • Mean age 53 years; 28% women • Although the primary endpoint was a
• Hospitalized with mild to moderate COVID-19 • 35% with HTN; 36% with DM negative SARS-CoV-2 RT-PCR result
on Day 6, no RT-PCR result or an
Interventions • 79% with mild COVID-19 inconclusive RT-PCR result was reported
• IVM 12 mg PO once daily for 2 days (n = 55) • Mean of 6.9 days from symptom onset for 42% of patients in the IVM arm and
• Placebo PO (n = 57) • 100% received HCQ, steroids, and antibiotics; 21% 23% in the placebo arm.
received RDV; 6% received tocilizumab. • The time to discharge was not reported,
Primary Endpoint and outcomes after discharge were not
Primary Outcome
• Negative SARS-CoV-2 RT-PCR result on Day 6 evaluated.
• Negative SARS-CoV-2 RT-PCR result on Day 6: 24% in
Key Secondary Endpoints IVM arm vs. 32% in placebo arm (rate ratio 0.8; P = Interpretation
• Symptom resolution by Day 6 0.348) • IVM provided no significant virologic or
• Discharge by Day 10 Secondary Outcomes clinical benefit for patients with mild to
moderate COVID-19.
• Need for ICU admission or MV • Symptom resolution by Day 6: 84% in IVM arm vs. 90% in
• In-hospital mortality 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%)

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 Methods Results Limitations and Interpretation

RIVET-COV: Double-Blind, Placebo-Controlled, Randomized Trial of Ivermectin in Patients With Mild to Moderate COVID-19 in India37
Key Inclusion Criteria Participant Characteristics Key Limitation
• Positive SARS-CoV-2 RT-PCR or antigen test result • Mean age 35 years; 89% men • Small sample size
• Nonsevere COVID-19 • 60% to 68% with mild COVID-19 (including asymptomatic Interpretation
patients); 33% to 40% with moderate COVID-19
Key Exclusion Criteria • The use of IVM did not affect the
• Median of 4–5 days symptom duration; similar across proportion of patients with negative
• CrCl <30 mL/min
arms SARS-CoV-2 RT-PCR results at Day 5 or
• Transaminases >5 times ULN the clinical outcomes.
• 10% in each arm received concurrent antivirals (RDV,
• MI, heart failure, QTc interval prolongation favipiravir, or HCQ).
• Severe comorbidity Primary Outcomes
Interventions • Negative SARS-CoV-2 RT-PCR result at Day 5: 48% in
• Single dose of IVM 24 mg PO (n = 51) IVM 24 mg arm vs. 35% in IVM 12 mg arm vs. 31% in
• Single dose of IVM 12 mg PO (n = 49) placebo arm (P = 0.30)
• Placebo (n = 52) • No significant difference between arms in decline of VL at
Day 5
Primary Endpoints
Secondary Outcomes
• Negative SARS-CoV-2 RT-PCR result at Day 5
• No difference between arms in time to symptom
• Decline of VL at Day 5 resolution
Key Secondary Endpoints • Clinical worsening at Day 14: 8% in IVM 24 mg arm vs.
• Time to symptom resolution 5% in IVM 12 mg arm vs. 11% in placebo arm (P = 0.65)
• Clinical worsening at Day 14 • No difference between arms in number of hospital-free
days at Day 28
• Number of hospital-free days at Day 28
• No difference between arms in frequency of AEs; no SAEs
• Frequency of AEs
were reported

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 Methods Results Limitations and Interpretation

Double-Blind RCT of Ivermectin, Chloroquine, or Hydroxychloroquine in Hospitalized Adults With Severe COVID-19 in Brazil38
Key Inclusion Criteria Participant Characteristics Key Limitations
• Hospitalized with laboratory-confirmed SARS-CoV-2 • Mean age 53 years; 58% men • Small sample size
infection • Most common comorbidities: 43% with HTN; 28% with • No clearly defined primary endpoint
• ≥1 of the following severity criteria: DM; 38% with BMI >30
Interpretation
• Dyspnea • 76% with respiratory failure on admission
• Compared to CQ or HCQ, IVM did not
• Tachypnea (>30 breaths/min) Outcomes reduce the proportion of hospitalized
• SpO2 <93% • No difference between IVM, CQ, and HCQ arms in: patients with severe COVID-19 who died
• PaO2/FiO2 <300 mm Hg or who required supplemental oxygen,
• Need for supplemental oxygen: 88% vs. 89% vs. 90% ICU admission, or MV
• Involvement of >50% of lungs confirmed by CXR or • Need for MV: 24% vs. 21% vs. 21%
CT scan
• ICU admission: 28% vs. 22% vs. 21%
Key Exclusion Criterion • Mortality: 23% vs. 21% vs. 22%
• Cardiac arrhythmia • Mean number of days of supplemental oxygen: 8 days
Interventions in each arm
• IVM 14 mg once daily for 3 days (n = 53) • No difference between arms in occurrence of AEs
• CQ 450 mg twice daily on Day 0, then once daily for 4 • Baseline characteristics significantly associated with
days (n = 61) mortality:
• HCQ 400 mg twice daily on Day 0, then once daily for 4 • Aged >60 years (HR 2.4)
days (n = 54) • DM (HR 1.9)
Endpoints • BMI >33 (HR 2.0)
• Need for supplemental oxygen, MV, or ICU admission • SpO2 <90% (HR 5.8)
• Occurrence of AEs
• Mortality
Key: AE = adverse event; ALT = alanine transaminase; BMI = body mass index; CNS = central nervous system; CQ = chloroquine; CrCl = creatinine clearance; CT =
computed tomography; CVD = cardiovascular disease; CXR = chest X-ray; DM = diabetes mellitus; ED = emergency department; eGFR = estimated glomerular filtration
rate; FDA = Food and Drug Administration; HCQ = hydroxychloroquine; HTN = hypertension; ICU = intensive care unit; ITT = intention-to-treat; IVM = ivermectin; LOS
= length of stay; MI = myocardial infarction; mITT = modified intention-to-treat; MV = mechanical ventilation; the Panel = the COVID-19 Treatment Guidelines Panel;
PaO2/FiO2 = ratio of arterial partial pressure of oxygen to fraction of inspired oxygen; PO = oral; RCT = randomized controlled trial; RDV = remdesivir; RT-PCR = reverse
transcriptase polymerase chain reaction; SAE = severe adverse event; SOC = standard of care; SpO2 = oxygen saturation; ULN = upper limit of normal; VL = viral load

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