CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Interferon beta-1aWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug3235 convalescent plasma Wiki 0.50
drug2413 Remdesivir Wiki 0.23
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D003289 Convalescence NIH 0.45

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults (ACTT-3)

ACTT-3 will evaluate the combination of interferon beta-1a and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.

NCT04492475 COVID-19 Drug: Interferon beta-1a Other: Placebo Drug: Remdesivir

Primary Outcomes

Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.

Measure: Time to recovery

Time: Day 1 through Day 29

Secondary Outcomes

Measure: Change from baseline in alanine aminotransferase (ALT)

Time: Day 1 through Day 29

Measure: Change from baseline in aspartate aminotransferase (AST)

Time: Day 1 through Day 29

Measure: Change from baseline in C-reactive protein (CRP)

Time: Day 1 through Day 29

Measure: Change from baseline in creatinine

Time: Day 1 through Day 29

Measure: Change from baseline in d-dimer concentration

Time: Day 1 through Day 29

Measure: Change from baseline in hemoglobin

Time: Day 1 through Day 29

Measure: Change from baseline in international normalized ratio (INR)

Time: Day 1 through Day 29

Measure: Change from baseline in platelets

Time: Day 1 through Day 29

Measure: Change from baseline in total bilirubin

Time: Day 1 through Day 29

Measure: Change from baseline in white blood cell count (WBC) with differential

Time: Day 1 through Day 29

Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.

Measure: Change in National Early Warning Score (NEWS) from baseline

Time: Day 1 through Day 29

Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.

Measure: Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs)

Time: Day 1 through Day 29

Description: An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

Measure: Cumulative incidence of serious adverse events (SAEs)

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of hospitalization

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of invasive mechanical ventilation

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of new non-invasive ventilation or high flow oxygen use

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of new oxygen use

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use

Time: Day 1 through Day 29

Description: Measured in days.

Measure: Duration of non invasive ventilation/high flow oxygen use

Time: Day 1 through Day 29

Description: Measured in days

Measure: Duration of oxygen use

Time: Day 1 through Day 29

Description: For any reason.

Measure: Incidence of discontinuation or temporary suspension of investigational therapeutics

Time: Day 1 through Day 10

Measure: Incidence of new non-invasive ventilation or high flow oxygen use

Time: Day 1 through Day 29

Measure: Incidence of new oxygen use

Time: Day 1 through Day 29

Measure: Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use

Time: Day 1 through Day 29

Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: Mean change in the ordinal scale

Time: Day 1 through Day 29

Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: Participant's clinical status at Day 15 by ordinal scale

Time: Day 15

Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: Percentage of subjects reporting each severity rating on an 8 point ordinal scale

Time: Days 3, 5, 8, 11, 22, and 29

Description: Date and cause of death (if applicable).

Measure: Subject 14-day mortality

Time: Day 1 through Day 15

Description: Date and cause of death (if applicable).

Measure: Subject 28-day mortality

Time: Day 1 through Day 29

Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: Time to an improvement of one category using an ordinal scale

Time: Day 1 through Day 29

Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

Measure: Time to an improvement of two categories using an ordinal scale

Time: Day 1 through Day 29

Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.

Measure: Time to discharge or to a National Early Warning Score (NEWS) of Time: Day 1 through Day 29

Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.

Measure: Time to recovery for participants not on mechanical ventilation (baseline ordinal score of 4, 5, or 6)

Time: Day 1 through Day 29

No related HPO nodes (Using clinical trials)