There is one clinical trial.
Interferon lambda is one of the main arms of the innate antiviral immune response and is critical for controlling respiratory viral infections in mice. Interferon lambda has a better side effect profile than other interferons because of the limited tissue distribution of its receptor. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming its safety. We propose to evaluate peginterferon-lambda in ambulatory and hospitalized patients with mild to moderate COVID-19.
Description: The proportion of participants with negative SARS-CoV-2 RNA on nasopharyngeal swab.
Measure: Cohort A (Ambulatory) - Primary Efficacy Endpoint Time: At day 8Description: Rate of combined treatment-emergent and treatment-related severe adverse events (SAEs).
Measure: Cohort A (Ambulatory) - Primary Safety Endpoint Time: Day 1 to Day 15Description: The proportion of participants with negative SARS-CoV-2 RNA on nasopharyngeal swab.
Measure: Cohort B (Hospitalized) - Primary Efficacy Endpoint Time: At Day 15Description: Rate of combined treatment-emergent and treatment-related severe adverse events (SAEs).
Measure: Cohort B (Hospitalized) - Primary Safety Endpoint Time: Day 1 to Day 30Description: Time to resolution of all symptoms (fever, cough, diarrhea)
Measure: Cohort A (Ambulatory) - Clinical Outcome #1 Time: Day 1 to Day 15Description: Change in respiratory symptom score.
Measure: Cohort A (Ambulatory) - Clinical Outcome #2 Time: Day 1 to Day 8Description: Change in gastrointestinal symptom score.
Measure: Cohort A (Ambulatory) - Clinical Outcome #3 Time: Day 1 to Day 8Description: Change in fever symptom score.
Measure: Cohort A (Ambulatory) - Clinical Outcome #4 Time: Day 1 to Day 8Description: Need for hospital admission.
Measure: Cohort A (Ambulatory) - Clinical Outcome #5 Time: Day 1 to Day 15Description: Adverse events.
Measure: Cohort A (Ambulatory) - Clinical Outcome #6 Time: Day 1 to Day 15Description: Serious adverse events.
Measure: Cohort A (Ambulatory) - Clinical Outcome #7 Time: Day 1 to Day 15Description: Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab
Measure: Cohort A (Ambulatory) - Virologic/Immunological Outcome #1 Time: At Day 4Description: Time to SARS-CoV-2 RNA negativity on mid-turbinate nasal swab
Measure: Cohort A (Ambulatory) - Virologic/Immunological Outcome #2 Time: Day 1 to Day 15Description: Proportion with SARS-CoV-2 RNA in blood and saliva.
Measure: Cohort A (Ambulatory) - Virologic/Immunological Outcome #3 Time: Day 1 and Day 8Description: Proportion with SARS-CoV-2 antibodies blood and saliva.
Measure: Cohort A (Ambulatory) - Virologic/Immunological Outcome #4 Time: Day 1 and Day 8Description: Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab by interferon lambda 4 (IFNL4) genotype
Measure: Cohort A (Ambulatory) - Virologic/Immunological Outcome #5 Time: Through day 8Description: Change in laboratory and inflammatory markers (hemoglobin, white blood cell count, lymphocyte count, ferritin, lactate dehydrogenase, c-reactive protein, D-dimers, troponin).
Measure: Cohort A (Ambulatory) - Virologic/Immunological Outcome #6 Time: Day 1 to Day 8Description: Proportion with symptom development among household contacts
Measure: Cohort A (Ambulatory) - Transmission Outcome #1 Time: Day 1 to Day 15Description: Proportion with confirmed diagnosis of COVID-19 among household contacts.
Measure: Cohort A (Ambulatory) - Transmission Outcome #2 Time: Day 1 to Day 30Description: ICU admission during hospitalization
Measure: Cohort B (Hospitalized) - Clinical Outcome #1 Time: Day 1 to day 30Description: Need for intubation
Measure: Cohort B (Hospitalized) - Clinical Outcome #2 Time: Day 1 to Day 15Description: Length of hospital stay
Measure: Cohort B (Hospitalized) - Clinical Outcome #3 Time: Day 1 to Day 15Description: Change in respiratory symptom score
Measure: Cohort B (Hospitalized) - Clinical Outcome #4 Time: Day 0 to 8 and Day 0 to 15Description: Readmission to hospital
Measure: Cohort B (Hospitalized) - Clinical Outcome #5 Time: By day 30 and Day 90Description: All-cause mortality
Measure: Cohort B (Hospitalized) - Clinical Outcome #6 Time: At day 30 and day 90Description: COVID-19-related mortality
Measure: Cohort B (Hospitalized) - Clinical Outcome #7 Time: At day 30Description: Resolution of CXR findings
Measure: Cohort B (Hospitalized) - Clinical Outcome #8 Time: At Day 15Description: Adverse (AEs)
Measure: Cohort B (Hospitalized) - Clinical Outcome #9 Time: By day 30Description: Serious Adverse Events (SAEs)
Measure: Cohort B (Hospitalized) - Clinical Outcome #10 Time: By day 30Description: Frequency of dose reduction or dose omission for the second dose of peginterferon lambda
Measure: Cohort B (Hospitalized) - Clinical Outcome #11 Time: Day 8 to day 12Description: Proportion negative for SARS-CoV-2 RNA by NP swab.
Measure: Cohort B (Hospitalized) - Virologic/Immunological Outcome #1 Time: Day 8Description: Time to SARS-CoV-2 RNA negativity by nasopharyngeal swab
Measure: Cohort B (Hospitalized) - Virologic/Immunological Outcome #2 Time: Day 1 to Day 15Description: Correlation of clinical and virologic response with interferon lambda 4 (IFNL4) genotype
Measure: Cohort B (Hospitalized) - Virologic/Immunological Outcome #3 Time: Through Day 15Description: Change in laboratory and inflammatory markers (hemoglobin, white blood cell count, lymphocyte count, ferritin, lactate dehydrogenase, c-reactive protein, D-dimers, troponin)
Measure: Cohort B (Hospitalized) - Virologic/Immunological Outcome #4 Time: From day 0 to day 8 and to day 15Description: Time to SARS-CoV-2 RNA negativity by rectal swab
Measure: Cohort B (Hospitalized) - Virologic/Immunological Outcome #5 Time: Day 0 to Day 8Description: Proportion with SARS-CoV-2 Antibody.
Measure: Cohort B (Hospitalized) - Virologic/Immunological Outcome #6 Time: At Day 8 and Day 15Description: Proportion with SARS-CoV-2 RNA in blood and saliva.
Measure: Cohort B (Hospitalized) - Virologic/Immunological Outcome #7 Time: Day 0, Day 8, and Day 15