IC14 (Anti-CD14) Treatment in Patients With SARS-CoV-2 (COVID-19)
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|ClinicalTrials.gov Identifier: NCT04391309|
Recruitment Status : Not yet recruiting
First Posted : May 18, 2020
Last Update Posted : June 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV2||Biological: IC14 Other: Placebo||Phase 2|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
The primary objective is to test the efficacy and safety of IC14, an antibody to the CD14 pattern-recognition receptor, in reducing the severity of respiratory disease in patients hospitalized with the SARS-CoV-2 virus, which causes the clinical illness known as COVID-19.
Specific Aim 1. Determine the efficacy and safety of IC14, an anti-CD14 chimeric antibody, in patients hospitalized with respiratory disease due to SARS-CoV-2, in terms of increasing the number of days alive and free of any episodes of acute respiratory failure through Day 22.
Specific Aim 2. Determine whether treatment with the IC14 antibody improves time to improvement in clinical status using an eight-point ordinal scale.
Three hundred patients will be randomized to IC14 (n=150) or placebo (n=150). Study drug will be administered daily on Days 1-4. Study participation will continue for 60 days after enrollment. Remdesivir concomitant therapy will be given.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, Double-Blind, Placebo-Controlled|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Placebo consists of identical-appearing diluent|
|Official Title:||Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Anti-CD14 Treatment in Patients With SARS-CoV-2 (COVID-19)|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: IC14, monoclonal antibody to CD14
150 patients randomized to 4 mg/kg on Day 1, 2 mg/kg on Days 2-4 intravenously
4 mg/kg on Day 1, 2 mg/kg on Days 2-4 in normal saline intravenously
Other Name: monoclonal antibody to CD14
Placebo Comparator: Placebo
150 patients randomized to Placebo diluent on Days 1-4 intravenously
Normal saline intravenously on Days 1-4
Other Name: Normal saline diluent
- Acute respiratory failure [ Time Frame: Day 1-22 ]Days alive and free of any episodes of acute respiratory failure through Day 22 defined by need for high-flow nasal cannula, noninvasive positive-pressure ventilation, endotracheal intubation and mechanical ventilation, and extracorporeal membrane oxygenation
- Time to clinical improvement [ Time Frame: Day 1-29 ]Defined as time to the first day that a subject is in categories 6, 7, or 8 on the Eight-Point Ordinal Scale. The Eight-Point 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.
- Acute respiratory failure [ Time Frame: Days 1-8, 1-15, 1-22, 1-29 ]Proportion of patients alive and free of any episode of acute respiratory failure through Days 8, 15, 22, and 29
- Invasive mechanical ventilation [ Time Frame: Days 1-8, 1-15, 1-22, 1-29 ]Proportion of patients alive and free of invasive mechanical ventilation through Days 8, 15, 22, and 29
- Acute respiratory failure [ Time Frame: Days 1-15 and 1-29 ]Days alive and free of acute respiratory failure through Days 15 and 29
- Invasive mechanical ventilation [ Time Frame: Days 1-15, 1-22, 1-29 ]Days alive and free of invasive mechanical ventilation through Days 15, 22, and 29
- Hospitalization [ Time Frame: Days 1-29 ]Days alive and hospitalized through Day 29
- Sequential Organ Failure Assessment [ Time Frame: Days 1-8, 1-15, 1-22 ]Change in Sequential Organ Failure Assessment (SOFA) score (range 0 [best] to 24 [worst]) from baseline to Day 8, Day 15, and Day 22
- Sequential Organ Failure Assessment [ Time Frame: Days 1-22 ]Worst SOFA score from baseline to Day 22
- Hospitalization [ Time Frame: Days 1-15, 1-29 ]Proportion of patients alive and discharged from the hospital at Days 15 and 29.
- Ordinal Scale [ Time Frame: Days 1-29 ]Mean change in the eight-point ordinal scale (1 [worst] to 8 [best]) through Day 29
- Time to clinical improvement [ Time Frame: Days 1-29 ]Time to improvement in one category from baseline using an eight-point ordinal scale (1 [worst] to 8 [best]) through Day 29.
- Time to clinical improvment [ Time Frame: Days 1-29 ]Time to improvement in two categories from baseline using an eight-point ordinal scale (1 [worst] to 8 [best]) through Day 29.
- Time to recovery [ Time Frame: Days 1-29 ]Time to recovery through Day 29. Day of recovery is defined as the first day on which the subject satisfies one of categories 6-8 from the ordinal scale.
- Change in C-reactive protein [ Time Frame: Day 4 compared to baseline; Day 8 compared to baseline ]Change in C-reactive protein in blood on Days 4 and 8 compared to baseline (from normal < 10 mg/L [normal] to >10 mg/L [worse])
- Adverse events [ Time Frame: Days 1-60 ]Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events
- Serious adverse events [ Time Frame: Days 1-60 ]Cumulative incidence of serious adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04391309
|Contact: Mark Wurfel, MD, PhD||206 email@example.com|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98104|
|Contact: Mark Wurfel, MD, PhD 206-897-5387 firstname.lastname@example.org|
|Principal Investigator:||Mark Wurfel, MD, PhD||University of Washington|