scholarly journals Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial

2020 ◽  
Author(s):  
Prasanna Jagannathan ◽  
Jason Andrews ◽  
Hector Bonilla ◽  
Haley Hedlin ◽  
Karen Jacobson ◽  
...  
Keyword(s):  
Single Dose ◽  
Confidence Interval ◽  
Median Time ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Secondary Endpoint ◽  
Liver Transaminase ◽  
Viral Shedding ◽  
Subcutaneous Dose

Abstract Type III interferons have been touted as promising therapeutics in outpatients with coronavirus disease 2019 (COVID-19). We conducted a randomized placebo-controlled trial in 120 patients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint, NCT04331899). In both the 60 patients receiving Lambda and 60 receiving placebo, the median time to cessation of viral shedding was 7 days (hazard ratio [HR] = 0.81; 95% confidence interval [CI] 0.56 to 1.19). Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively (HR 0.94; 95% CI 0.64 to 1.39). At enrollment; 41% of subjects were SARS-CoV-2 IgG seropositive; compared to placebo, lambda tended to delay shedding cessation in seronegatives (aHR 0.66, 95% CI 0.39-1.10) and to hasten shedding cessation in seropositives (aHR 1.58, 95% CI 0.88-2.86; p for interaction = 0.03). Liver transaminase elevations were more common in the Lambda vs. placebo arm (15/60 vs 5/60; p = 0.027). In this study, a single dose of subcutaneous Peginterferon Lambda-1a neither shortened the duration of SARS-CoV-2 viral shedding nor improved symptoms in outpatients with uncomplicated COVID-19.

scholarly journals Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial

2020 ◽  
Author(s):  
Prasanna Jagannathan ◽  
Jason R. Andrews ◽  
Hector Bonilla ◽  
Haley Hedlin ◽  
Karen B. Jacobson ◽  
...  
Keyword(s):  
Single Dose ◽  
Confidence Interval ◽  
Median Time ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Secondary Endpoint ◽  
Liver Transaminase ◽  
Viral Shedding ◽  
Subcutaneous Dose

AbstractType III interferons have been touted as promising therapeutics in outpatients with coronavirus disease 2019 (COVID-19). We conducted a randomized placebo-controlled trial in 120 patients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint, NCT04331899). In both the 60 patients receiving Lambda and the 60 receiving placebo, the median time to cessation of viral shedding was 7 days (hazard ratio [HR] = 0.81; 95% confidence interval [CI] 0.56 to 1.19). Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively (HR 0.94; 95% CI 0.64 to 1.39). At enrollment; 41% of subjects were SARS-CoV-2 IgG seropositive; compared to placebo, lambda tended to delay shedding cessation in seronegatives (aHR 0.66, 95% CI 0.39-1.10) and to hasten shedding cessation in seropositives (aHR 1.58, 95% CI 0.88-2.86; p for interaction = 0.03). Liver transaminase elevations were more common in the Lambda vs. placebo arm (15/60 vs 5/60; p = 0.027). In this study, a single dose of subcutaneous Peginterferon Lambda-1a neither shortened the duration of SARS-CoV-2 viral shedding nor improved symptoms in outpatients with uncomplicated COVID-19.

scholarly journals Peginterferon Lambda-1a for treatment of outpatients with uncomplicated COVID-19: a randomized placebo-controlled trial

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Prasanna Jagannathan ◽  
Jason R. Andrews ◽  
Hector Bonilla ◽  
Haley Hedlin ◽  
Karen B. Jacobson ◽  
...  
Keyword(s):  
Single Dose ◽  
Confidence Interval ◽  
Median Time ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Symptom Duration ◽  
Liver Transaminase ◽  
Viral Shedding ◽  
Subcutaneous Dose ◽  
Single Blind

AbstractType III interferons have been touted as promising therapeutics in outpatients with coronavirus disease 2019 (COVID-19). We conducted a randomized, single-blind, placebo-controlled trial (NCT04331899) in 120 outpatients with mild to moderate COVID-19 to determine whether a single, 180 mcg subcutaneous dose of Peginterferon Lambda-1a (Lambda) within 72 hours of diagnosis could shorten the duration of viral shedding (primary endpoint) or symptoms (secondary endpoint). In both the 60 patients receiving Lambda and 60 receiving placebo, the median time to cessation of viral shedding was 7 days (hazard ratio [HR] = 0.81; 95% confidence interval [CI] 0.56 to 1.19). Symptoms resolved in 8 and 9 days in Lambda and placebo, respectively, and symptom duration did not differ significantly between groups (HR 0.94; 95% CI 0.64 to 1.39). Both Lambda and placebo were well-tolerated, though liver transaminase elevations were more common in the Lambda vs. placebo arm (15/60 vs 5/60; p = 0.027). In this study, a single dose of subcutaneous Peginterferon Lambda-1a neither shortened the duration of SARS-CoV-2 viral shedding nor improved symptoms in outpatients with uncomplicated COVID-19.

Abstract 15091: Significant Reductions in Both Adjudicated and Investigator-Reported Ischemic Events in REDUCE-IT

Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Deepak L Bhatt ◽  
Robert Giugliano ◽  
Philippe G Steg ◽  
Michael Miller ◽  
Eliot A Brinton ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Coronary Revascularization ◽  
Hazard Ratio ◽  
Secondary Endpoint ◽  
Icosapent Ethyl ◽  
Clinical Events ◽  
High Degree ◽  
Ischemic Events ◽  
Fatal Myocardial Infarction

Introduction: REDUCE-IT was an event-driven trial that randomized 8,179 statin-treated patients with controlled LDL-C and moderately elevated triglycerides to icosapent ethyl (IPE) 4g daily or placebo, with a median of 4.9 years of follow-up. There was a significant reduction in the prespecified adjudicated rates of the primary endpoint (cardiovascular [CV] death, non-fatal myocardial infarction [MI], non-fatal stroke, coronary revascularization, and unstable angina requiring hospitalization) and of the key secondary endpoint (CV death, MI, stroke), as well as in all the primary endpoint components. We sought to determine the effect of IPE on investigator-reported events. Methods: The Clinical Endpoint Committee (CEC) blindly adjudicated investigator-reported events according to a prespecified charter. Medical records and reports were also reviewed to assess for clinical events not reported by investigators. An endpoint management team compiled and electronically provided event packets to the CEC via an adjudication database. The CEC Chair provided final adjudication if the two primary adjudicators could not reach consensus. Results: IPE significantly reduced the rate of the primary endpoint (hazard ratio 0.74, p=0.0000000002) and the key secondary endpoint (hazard ratio 0.75, p=0.000007) as reported by the site investigators, with consistent benefits in each component of the primary endpoint (Table). There was a high degree of concordance between investigator-reported and adjudicated endpoints. Conclusions: Icosapent ethyl significantly reduced multiple types of ischemic events, both by independent, blinded adjudication as well as by investigator-reported assessment. These results underscore the robustness of the benefits of icosapent ethyl seen in REDUCE-IT.

Lithium vs valproate in the maintenance treatment of bipolar I disorder: A post- hoc analysis of a randomized double-blind placebo-controlled trial

2019 ◽  
Vol 54 (3) ◽  
pp. 298-307
Author(s):  
Mehar G Kang ◽  
Hong Qian ◽  
Kamyar Keramatian ◽  
Trisha Chakrabarty ◽  
Gayatri Saraf ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Atypical Antipsychotic ◽  
Maintenance Treatment ◽  
Atypical Antipsychotics ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Hoc Analysis ◽  
Post Hoc

Objective: Lithium and valproate are commonly used either in monotherapy or in combination with atypical antipsychotics in maintenance treatment of bipolar I disorder; however, their comparative efficacy is not well understood. This study aimed to compare the efficacy of valproate and lithium on mood stability either in monotherapy or in combination with atypical antipsychotics. Methods: We performed a post hoc analysis using data from a 52-week randomized double-blind, placebo-controlled trial, that recruited 159 patients with recently remitted mania during treatment with lithium or valproate and adjunctive atypical antipsychotic therapy. Patients were randomized to discontinue adjunctive atypical antipsychotic at 0, 24 or 52 weeks. Results: No significant differences in efficacy were observed between valproate and lithium (hazard ratio: 0.99; 95% confidence interval: [0.66, 1.48]) in time to any mood event. Valproate with 24 weeks of atypical antipsychotic was significantly superior to valproate monotherapy in preventing any mood relapse (hazard ratio: 0.46; 95% confidence interval: [0.22, 0.97]) while lithium with 24 weeks of atypical antipsychotic was superior to lithium monotherapy in preventing mania (hazard ratio: 0.27; 95% confidence interval: [0.09, 0.85]) but not depression. Conclusion: Overall, this study did not find significant differences in efficacy between the two mood-stabilizing agents when used as monotherapy or in combination with atypical antipsychotics. However, study design and small sample size might have precluded from detecting an effect if true difference in efficacy existed. Further head-to-head investigations with stratified designs are needed to evaluate maintenance therapies.

Body Mass and Weekly Training Distance Influence the Pain and Injuries Experienced by Runners Using Minimalist Shoes: A Randomized Controlled Trial

2017 ◽  
Vol 45 (5) ◽  
pp. 1162-1170 ◽  
Author(s):  
Joel T. Fuller ◽  
Dominic Thewlis ◽  
Jonathan D. Buckley ◽  
Nicholas A.T. Brown ◽  
Joseph Hamill ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Body Mass ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Level Of Evidence ◽  
Safe Alternative ◽  
Visual Analog Scales ◽  
Weekly Training ◽  
Running Shoes ◽  
Clinical Trials Registry

Background: Minimalist shoes have been popularized as a safe alternative to conventional running shoes. However, a paucity of research is available investigating the longer-term safety of minimalist shoes. Purpose: To compare running-related pain and injury between minimalist and conventional shoes in trained runners and to investigate interactions between shoe type, body mass, and weekly training distance. Study Design: Randomized clinical trial; Level of evidence, 2. Methods: Sixty-one trained, habitual rearfoot footfall runners (mean ± SD: body mass, 74.6 ± 9.3 kg; weekly training distance, 25 ± 14 km) were randomly allocated to either minimalist or conventional shoes. Runners gradually increased the time spent running in their allocated shoes over 26 weeks. Running-related pain intensity was measured weekly by use of 100-mm visual analog scales. Time to first running-related injury was also assessed. Results: Interactions were found between shoe type and weekly training distance for weekly running-related pain; greater pain was experienced with minimalist shoes ( P < .05), and clinically meaningful increases (>10 mm) were noted when the weekly training distance was more than 35 km/wk. Eleven of 30 runners sustained an injury in conventional shoes compared with 16 of 31 runners in minimalist shoes (hazard ratio, 1.64; 95% confidence interval, 0.63-4.27; P = .31). A shoe × body mass interaction was found for time to first running-related injury ( P = .01). For runners using minimalist shoes, relative to runners using conventional shoes, the risk of sustaining an injury became more likely with increasing body mass above 71.4 kg, and the risk was moderately increased (hazard ratio, 2.00; 95% confidence interval, 1.10-3.66; P = .02) for runners using minimalist shoes who had a body mass of 85.7 kg. Conclusions: Runners should limit weekly training distance in minimalist shoes to avoid running-related pain. Heavier runners are at greater risk of injury when running in minimalist shoes. Registration: Australian New Zealand Clinical Trials Registry (ACTRN12613000642785).

P5639Risk stratification for mortality using electrocardiographic markers based on 24-hour holter recordings: the JANIES-SHD study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
T Kinoshita ◽  
K Hashimoto ◽  
K Yoshioka ◽  
Y Miwa ◽  
K Yodogawa ◽  
...  
Keyword(s):  
Heart Disease ◽  
Risk Stratification ◽  
Primary Endpoint ◽  
Left Ventricular ◽  
Hazard Ratio ◽  
Secondary Endpoint ◽  
Cardiac Mortality ◽  
Holter Ecg ◽  
All Cause Mortality ◽  
Holter Recordings

Abstract Background Recent guidelines have stated that reduced left ventricular ejection fraction (LVEF) is the gold standard marker for identifying patients at risk for cardiac mortality. Although reduced LVEF identifies patients at an increased risk of cardiac arrest, sudden cardiac deaths (SCDs) occur considerably more often in patients with relatively preserved LVEF. Current guidelines on SCD risk stratification do not adequately cover this general population pool. Several noninvasive electrocardiographic (ECG) risk stratifiers that reflect depolarization abnormality, repolarization abnormality, and autonomic imbalance have been evaluated so far. With current therapeutic advances using new medicines or devices, an LVEF is often preserved in patients with structural heart disease (SHD). However, the usefulness of noninvasive ECG markers for risk stratification in such a patient population has not yet been elucidated. Purpose This study aimed to assess clinical indices and ECG markers based on 24-hour Holter ECG recordings for predicting cardiac mortality in patients with SHD who have left ventricular dysfunction (LVD) but relatively preserved LVEF. Methods In total, 1,829 patients were enrolled into the Japanese Multicenter Observational Prospective Study (JANIES study). In this study, we analyzed data of 719 patients (569 men, age 64±13 years) with SHD including mainly ischemic heart disease (65.8%). As ECG markers based on 24-hour Holter recordings, nonsustained ventricular tachycardia (NSVT), ventricular late potentials, and heart rate turbulence (HRT) were assessed. The primary endpoint was all-cause mortality, and the secondary endpoint was fatal arrhythmic events. Results During a mean follow-up of 21±11 months, all-cause mortality was eventually observed in 39 patients (5.4%). Among those patients, 32 patients (82%) suffered from cardiac causes such as heart failure and arrhythmia. Multivariate Cox regression analysis showed that after adjustment for age and LVEF, documented NSVT (hazard ratio=2.82, 95% confidence interval [CI]: 1.38–5.76, P=0.005) and abnormal HRT (hazard ratio=2.31, 95% CI: 1.15–4.65, P=0.02) were significantly associated with the primary endpoint. These two ECG markers also had significant predictive values with the secondary endpoint. The combined assessment documented NSVT and abnormal HRT improved predictive accuracy. Conclusion This study demonstrated that combined assessment of documented NSVT and abnormal HRT based on 24-hour Holter ECG recordings are recommended for predicting future serious events in SHD patients who have relatively preserved LVEF. Acknowledgement/Funding Grants-in-Aid (21590909, 24591074, and 15K09103 to T.I.) for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technol

CONCERTO: A randomized, placebo-controlled trial of oral laquinimod in relapsing-remitting multiple sclerosis

2021 ◽  
pp. 135245852110328
Author(s):  
Giancarlo Comi ◽  
Yuval Dadon ◽  
Nissim Sasson ◽  
Joshua R Steinerman ◽  
Volker Knappertz ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Adaptive Immune Response ◽  
Secondary Endpoint ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Relapsing Remitting ◽  
Remitting Multiple Sclerosis ◽  
Relapsing Remitting Multiple Sclerosis

Background: Interventions targeting the adaptive immune response are needed in multiple sclerosis (MS). Objective: Evaluate laquinimod’s efficacy, safety, and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS). Methods: CONCERTO was a randomized, double-blind, placebo-controlled, phase-3 study. RRMS patients were randomized 1:1:1 to receive once-daily oral laquinimod 0.6 or 1.2 mg or placebo for ⩽24 months ( n = 727, n = 732, and n = 740, respectively). Primary endpoint was time to 3-month confirmed disability progression (CDP). The laquinimod 1.2-mg dose arm was discontinued (1 January 2016) due to cardiovascular events at high doses. Safety was monitored throughout the study. Results: CONCERTO did not meet the primary endpoint of significant effect with laquinimod 0.6-mg versus placebo on 3-month CDP (hazard ratio: 0.94; 95% confidence interval: 0.67–1.31; p = 0.706). Secondary endpoint p values were nominal and non-inferential. Laquinimod 0.6 mg demonstrated 40% reduction in percent brain volume change from baseline to Month 15 versus placebo ( p < 0.0001). The other secondary endpoint, time to first relapse, and annualized relapse rate (an exploratory endpoint) were numerically lower (both, p = 0.0001). No unexpected safety findings were reported with laquinimod 0.6 mg. Conclusion: Laquinimod 0.6 mg demonstrated only nominally significant effects on clinical relapses and magnetic resonance imaging (MRI) outcomes and was generally well tolerated. Clinical trial registration number: ClinicalTrials.gov (NCT01707992).

Severe Acute Kidney Injury and Mortality in Extremely Low Gestational Age Neonates

2021 ◽  
Vol 16 (6) ◽  
pp. 862-869
Author(s):  
Sangeeta Hingorani ◽  
Robert H. Schmicker ◽  
Patrick D. Brophy ◽  
Patrick J. Heagerty ◽  
Sandra E. Juul ◽  
...  
Keyword(s):  
Confidence Interval ◽  
Gestational Age ◽  
Regression Models ◽  
Cox Regression ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Time Dependent ◽  
Recombinant Erythropoietin ◽  
The Relationship ◽  
Extremely Low Gestational Age

Background and objectivesAKI is associated with poor short- and long-term outcomes. Questions remain about the frequency and timing of AKI, and whether AKI is a cause of death in extremely low gestational age neonates.Design, setting, participants, & measurementsThe Recombinant Erythropoietin for Protection of Infant Kidney Disease Study examines the kidney outcomes of extremely low gestational age neonates enrolled in the Preterm Epo Neuroprotection study, a randomized, placebo-controlled trial of recombinant human erythropoietin. We included 900 of 941 patients enrolled in Preterm Epo Neuroprotection. Baseline characteristics were compared by primary exposure (severe AKI versus none/stage 1 AKI) using unadjusted logistic regression models. Cox regression models estimated the relationship between severe AKI and death after adjustment for potential confounders. Time-dependent AKI was modeled as a binary outcome and a categorical variable by stage of AKI. We fit Cox models using time-dependent AKI status lagged by <7 days before death. Landmark analyses examined the relationship of death with development of severe AKI.ResultsSevere AKI occurred in 168 of 900 (19%, 95% confidence interval, 17% to 20%) neonates, and stage 3 AKI occurred in 60 (7%, 95% confidence interval, 5% to 8%). Stage 3 AKI occurring 7 days before death (hazard ratio, 3.88; 95% confidence interval, 1.26 to 11.96), intraventricular hemorrhage (hazard ratio, 2.01; 95% confidence interval, 1.01 to 3.99) and sepsis (hazard ratio, 2.85; 95% confidence interval, 1.12 to 7.22) were all independently associated with death. Severe AKI occurring 7 days before death (hazard ratio, 2.21; 95% confidence interval, 0.92 to 5.26) was associated with death but not statistically significant. In a landmark analysis, after adjusting for potential confounders, late (after day 14 and before day 28) severe AKI was strongly associated with higher hazard of death (hazard ratio, 4.57; 95% confidence interval, 1.82 to 11.5).ConclusionsSevere AKI occurs frequently in extremely low gestational age neonates. Stage 3 AKI is associated with mortality, and this association is present 7 days before death.

scholarly journals Association of admission and discharge anemia status with outcomes in patients hospitalized for acute decompensated heart failure: Differences between patients with preserved and reduced ejection fraction

2017 ◽  
Vol 8 (7) ◽  
pp. 606-614 ◽  
Author(s):  
Katsuya Kajimoto ◽  
Yuichiro Minami ◽  
Shigeru Otsubo ◽  
Naoki Sato
Keyword(s):  
Heart Failure ◽  
Confidence Interval ◽  
Ejection Fraction ◽  
Primary Endpoint ◽  
Acute Decompensated Heart Failure ◽  
Decompensated Heart Failure ◽  
Hazard Ratio ◽  
Preserved Ejection Fraction ◽  
Reduced Ejection Fraction ◽  
Heart Failure Patients

Background: In acute decompensated heart failure patients with a preserved or reduced ejection fraction, the association of admission and discharge anemia status with outcomes remains unclear. Methods and results: Of the 4842 patients enrolled in the Acute Decompensated Heart Failure Syndromes (ATTEND) registry, 4433 patients (2017 with a preserved and 2416 with a reduced ejection fraction) were examined to investigate associations among the anemia status at admission and discharge (no anemia, developed anemia, resolved anemia, or persistent anemia), a preserved or reduced ejection fraction and the primary endpoint (all-cause death and readmission for heart failure). In the preserved ejection fraction group, adjusted analysis showed that either developed or persistent anemia was associated with a significantly higher risk of the primary endpoint relative to no anemia (hazard ratio: 1.53; 95% confidence interval (CI): 1.11–2.11; p=0.009 and hazard ratio: 1.60; 95% CI: 1.26–2.04; p<0.001, respectively), but there was no association between resolved anemia and the primary endpoint (hazard ratio: 0.98; 95% CI: 0.67–1.45; p=0.937). In the reduced ejection fraction group, either developed or resolved anemia was associated with a tendency toward higher risk of the primary endpoint relative to no anemia (hazard ratio: 1.29; 95% CI: 0.95–1.62; p=0.089, and hazard ratio: 1.31; 95% CI: 0.96–1.77; p=0.085, respectively), while persistent anemia was associated with a significantly higher risk of the primary endpoint relative to no anemia (hazard ratio: 1.36; 95% CI: 1.12–1.65; p=0.002). Conclusions: In acute decompensated heart failure patients, the association of admission and discharge anemia status with outcomes differs markedly between patients with a preserved or reduced ejection fraction.

scholarly journals Ivermectin in combination with doxycycline for treating COVID-19 symptoms: a randomized trial

2021 ◽  
Vol 49 (5) ◽  
pp. 030006052110135
Author(s):  
Reaz Mahmud ◽  
Md. Mujibur Rahman ◽  
Iftikher Alam ◽  
Kazi Gias Uddin Ahmed ◽  
A.K.M. Humayon Kabir ◽  
...  
Keyword(s):  
Placebo Group ◽  
Treatment Group ◽  
Confidence Interval ◽  
Recovery Time ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Data Repository ◽  
Rt Pcr ◽  
Clinical Recovery ◽  
Number Of Patients

Objective We evaluated whether ivermectin combined with doxycycline reduced the clinical recovery time in adults with COVID-19 infection. Methods This was a randomized, blinded, placebo-controlled trial in patients with mild-to-moderate COVID-19 symptoms randomly assigned to treatment (n = 200) and placebo (n = 200) groups. The primary outcome was duration from treatment to clinical recovery. Secondary outcomes were disease progression and persistent COVID-19 positivity by RT-PCR. Results Among 556 screened patients, 400 were enrolled and 363 completed follow-up. The mean patient age was 40 years, and 59% were men. The median recovery time was 7 (4–10, treatment group) and 9 (5–12, placebo group) days (hazard ratio, 0.73; 95% confidence interval, 0.60–0.90). The number of patients with a ≤7-day recovery was 61% (treatment group) and 44% (placebo groups) (hazard ratio, 0.06; 95% confidence interval, 0.04–0.09). The proportion of patients who remained RT-PCR positive on day 14 and whose disease did not progress was significantly lower in the treatment group than in the placebo group. Conclusions Patients with mild-to-moderate COVID-19 infection treated with ivermectin plus doxycycline recovered earlier, were less likely to progress to more serious disease, and were more likely to be COVID-19 negative by RT-PCR on day 14. Trial Registration ClinicalTrials.gov Identifier: NCT04523831. Data Repository ID Dryad. doi:10.5061/dryad.qjq2bvqf6

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