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NCT04388709
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Interferon Lambda Therapy for COVID-19 |
Withdrawn |
Phase 2 |
Sep/01/2020 |
Feb/05/2021 |
- Alternative id - GCO 20-0820
- Interventions - Drug: Peginterferon Lambda-1A
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Number of participants with resolution of hypoxia|Number of adverse events.|Days with fever|Time to resolution of fever|Rate of progression to requiring critical care|Overall survival|Time to discharge
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NCT04354259
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Interferon Lambda for Immediate Antiviral Therapy at Diagnosis in COVID-19 |
Recruiting |
Phase 2 |
May/13/2020 |
Jan/15/2023 |
- Alternative id - 20-5334
- Interventions - Drug: Peginterferon Lambda-1A|Other: placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital das Clínicas da Faculdade de Medicina de Botucatu, Botucatu, Brazil|Hospital das Clínicas São Paulo, Sao Paulo, Brazil|Hospital Alemão Oswaldo Cruz, São Paulo, Brazil|University of Calgary, Calgary, Alberta, Canada|Michael Garron Hospital, Toronto, Ontario, Canada|Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada|University Health Network, Toronto, Ontario, Canada
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 240
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Cohort A (Ambulatory) - Proportion swab negative at day 7 (Primary efficacy endpoint)|Cohort A (Ambulatory) - Treatment-emergent and treatment related serious adverse events (Primary Safety Endpoint)|Cohort B (Hospitalized) - Ordinal Scale (Primary Efficacy Endpoint)|Cohort B (Hospitalized) - treatment-emergent and treatment-related serious adverse events (Primary Safety Endpoint)|Cohort A (Ambulatory) - Symptom Resolution (Clinical Outcome #1)|Cohort A (Ambulatory) - Symptom severity scores (Clinical Outcome #2)|Cohort A (Ambulatory) - Hospitalization (Clinical Outcome #3)|Cohort A (Ambulatory) - Adverse and serious adverse events (Clinical Outcome #4)|Cohort A (Ambulatory) - Swab negative at day 3 (Virologic/Immunological Outcome #1)|Cohort A (Ambulatory) - Time RNA negativity (Virologic/Immunological Outcome #2)|Cohort A (Ambulatory) - Proportion viremic (Virologic/Immunological Outcome #3)|Cohort A (Ambulatory) - Proportion with antibodies (Virologic/Immunological Outcome #4)|Cohort A (Ambulatory) - Correlation with interferon lambda 4 genotype (Virologic/Immunological Outcome #5)|Cohort A (Ambulatory) - Symptoms in household contacts (Transmission Outcome #1)|Cohort A (Ambulatory) - COVID-19 in household contacts (Transmission Outcome #2)|Cohort B (Hospitalized) - Ordinal scale (Clinical Outcome #1)|Cohort B (Hospitalized) - ICU admission (Clinical Outcome #2)|Cohort B (Hospitalized) - Need for intubation (Clinical Outcome #3)|Cohort B (Hospitalized) - Length of hospital stay (Clinical Outcome #4)|Cohort B (Hospitalized) - Change in respiratory symptom score (Clinical Outcome #5)|Cohort B (Hospitalized) - All-cause mortality (Clinical Outcome #6)|Cohort B (Hospitalized) - Readmission to hospital (Clinical Outcome #7)|Cohort B (Hospitalized) - COVID-19-related mortality (Clinical Outcome #8)|Cohort B (Hospitalized) - Adverse (AEs) and Serious Adverse Events (SAEs) (Clinical Outcome #9)|Cohort B (Hospitalized) - Dose reduction or dose omission (Clinical Outcome #10)|Cohort B (Hospitalized) - Time to viral negativity (Virologic/Immunological Outcome #1)|Cohort B (Hospitalized) - Proportion negative swab. (Virologic/Immunological Outcome #2)|Cohort B (Hospitalized) - Quantitative viral load by nasal swab (Virologic/Immunological Outcome #3)|Cohort B (Hospitalized) - Correlation with interferon lambda 4 (IFNL4) genotype (Virologic/Immunological Outcome #4)|Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #5)|Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #6)|Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #7)|Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #8)|Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #9)|Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #10)|Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #11)|Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #12)|Cohort B (Hospitalized) - Safety Markers (Virologic/Immunological Outcome #13)|Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #14)|Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #15)|Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #16)|Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #17)|Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #18)|Cohort B (Hospitalized) - Inflammatory Markers (Virologic/Immunological Outcome #19)|Cohort B (Hospitalized) - Proportion with Antibody (Virologic/Immunological) Outcome #20)|Cohort B (Hospitalized) - Proportion with viremia (Virologic/Immunological Outcome #21)
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NCT04331899
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Single-Blind Study of a Single Dose of Peginterferon Lambda-1a Compared With Placebo in Outpatients With Mild COVID-19 |
Completed |
Phase 2 |
Apr/25/2020 |
May/06/2021 |
- Alternative id - 55619
- Interventions - Drug: Peginterferon Lambda-1a|Other: Placebo
- Study type - Interventional
- Study results - Has Results
- Locations - Stanford University School of Medicine, Stanford, California, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Treatment
- Enrollment - 120
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Duration Until Viral Shedding Cessation|Change in Sars-CoV-2 Viral Load|Area Under the Curve of SARS-COV-2 Viral Load|Duration Until Resolution of Symptoms|Count of Participants Requiring Emergency Department Visits or Hospitalizations Within 28 Days of Initiation of Treatment
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NCT04967430
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TOGETHER - Toronto: Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19 |
Recruiting |
Phase 3 |
Aug/27/2021 |
Dec/14/2022 |
- Alternative id - JF-12-2020|21-5018
- Interventions - Drug: Peginterferon Lambda-1A|Other: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Toronto General Hospital, Toronto, Ontario, Canada
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 763
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - COVID-19 related urgent care visit, emergency room assessment, hospitalization or death by Day 28 (Primary efficacy endpoint)|SARS-CoV-2 RNA negativity (Primary virological endpoint)|Treatment-emergent and treatment-related serious adverse events (Primary safety endpoint)|Respiratory symptom resolution (Clinical Outcome #1)|Hospitalization (Clinical outcome #2)|Death (Clinical outcome #3)|All symptom resolution (Clinical outcome #4)|Oxygen saturation on room air (Clinical outcome #5)|Seeking care from healthcare professional for COVID-19 (Clinical outcome #6)|Hospital Admission (Clinical outcome #7)|Time to viral negativity (Virologic/immunological outcome #1)|Mean log of SARS-CoV-2 RNA (Virologic/immunological outcome #2)|Mean log decline in SARS-CoV-2 RNA (Virologic/immunological outcome #3)|Negative for SARS-CoV-2 RNA (Virologic/immunological outcome #4)|Negative for SARS-CoV-2 RNA (Virologic/immunological outcome #5)|Negative for SARS-CoV-2 RNA (Virologic/immunological outcome #6)|Proportion with antibodies (Virologic/immunological outcome #7)|Correlation with interferon lambda 4 genotype (Virologic/immunological outcome #8)|Laboratory markers (Virologic/immunological outcome #9)|Laboratory markers (Virologic/immunological outcome #10)|Laboratory markers (Virologic/immunological outcome #11)|Laboratory markers (Virologic/immunological outcome #12)|Laboratory markers (Virologic/immunological outcome #13)|Laboratory markers (Virologic/immunological outcome #14)|Laboratory markers (Virologic/immunological outcome #15)|Inflammatory markers (Virologic/immunological outcome #16)|Inflammatory markers (Virologic/immunological outcome #17)|Inflammatory markers (Virologic/immunological outcome #18)|Inflammatory markers (Virologic/immunological outcome #19)|COVID-19 in household contacts (Transmission outcome #1)
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NCT04344600
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Peginterferon Lambda-1a for the Prevention and Treatment of SARS-CoV-2 (COVID-19) Infection |
Terminated |
Phase 2 |
Jun/29/2020 |
Sep/24/2021 |
- Alternative id - IRB00248163
- Interventions - Drug: Peginterferon lambda alfa-1a subcutaneous injection|Other: Saline
- Study type - Interventional
- Study results - No Results Available
- Locations - Johns Hopkins Hospital, Baltimore, Maryland, United States
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Single (Participant)|Primary Purpose: Prevention
- Enrollment - 6
- Age - 18 Years to 80 Years (Adult, Older Adult)
- Outcome measures - Proportion of participants with no evidence of SARS-CoV-2 infection|Time (days) to no detection of SARS-CoV-2 in two upper respiratory samples
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NCT04727424
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Repurposed Approved and Under Development Therapies for Patients With Early-Onset COVID-19 and Mild Symptoms |
Recruiting |
Phase 3 |
Jan/19/2021 |
Nov/01/2023 |
- Alternative id - TOGETHER_2
- Interventions - Drug: Fluvoxamine Maleate 100 MG [Luvox]|Drug: Budesonide Powder|Drug: Placebo (mild disease)|Drug: Peginterferon Lambda-1a|Drug: Placebo (SpO2 < 94%)
- Study type - Interventional
- Study results - No Results Available
- Locations - City of Betim, Betim, MG, Brazil|Hospital e Maternidade Santa Rita, Contagem, MG, Brazil|City of Governador Valadares, Governador Valadares, MG, Brazil|City of Ibirité, Ibirité, MG, Brazil|City of Nova Lima, Nova Lima, MG, Brazil|City of Santa Luzia, Santa Luzia, MG, Brazil|City of Sete Lagoas, Sete Lagoas, MG, Brazil|CARDRESEARCH - Cardiologia Assistencial e de Pesquisa, Belo Horizonte, Minas Gerais, Brazil|City of Brumadinho, Brumadinho, Minas Gerais, Brazil|City of Igarapé, Igarapé, Minas Gerais, Brazil|Centro Universitário FIPMOC, Montes Claros, Minas Gerais, Brazil|Universidade Federal de Ouro Preto, Ouro Preto, Minas Gerais, Brazil
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 4669
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Rate of fluvoxamine + budesonide, peginterferon Lambda and fluvoxamine in changing the need for emergency care AND observation for more than 06 hours due to the worsening of COVID-19;|Rate of fluvoxamine + budesonide, peginterferon Lambda and fluvoxamine in changing the need for Hospitalization due to COVID-19 progression and related complications, including lower respiratory tract infection (LRTI)|Change in viral load on day 03 and 07 after randomization (interferon lambda arm)|Time to clinical changes (up to 28 days of randomization), defined as greater than 50% symptoms changing in reference to baseline symptoms)|Time to clinical failure, defined as time to need for hospitalization due to the clinical progression of COVID-19 or associated complications.|Number of days with respiratory symptoms since randomization|Rate of all-cause hospitalizations|Rate of COVID-19 related hospitalizations|Number of days on Mechanical Ventilator|Number of Days on Intensive Care Unit|Number of days on hospitalizations|Health and Functioning after COVID-19 disease|WHO ordinal scale for clinical improvement|Number of days on respiratory Symptoms|Adherence of Study drug
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