Trial · NCT04602000
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection (Part 1) | Up to Day 28 | ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Proportion of Patients With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1) | Up to Day 14 | ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time to Negative Conversion in Nasopharyngeal Swab Specimen (Part 1) | Up to Day 14 | ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) | days | MEDIAN |
| PRIMARY | Time to Clinical Recovery (Part 1) | Up to Day 14 | ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included; Patients who have absent for all symptoms or at least one missing at baseline are excluded.) | days | MEDIAN |
| PRIMARY | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in High-risk Patients (Part 2) | Up to Day 28 | ITT Set - High Risk (defined as all randomly assigned patients to the study drug, who were at high-risk for progressing to severe COVID-19 and/or hospitalization and who met at least 1 of the high-risk criteria) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With Clinical Symptom Requiring Hospitalization, Oxygen Therapy, or Experiencing Mortality Due to SARS-CoV-2 Infection up to Day 28 in All Randomized Patients (Part 2) | Up to Day 28 | ITT Set (defined as all randomly assigned patients to the study drug) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Clinical Recovery up to Day 14 in High-risk Patients (Part 2) | Up to Day 14 | ITT Set - High Risk (defined as all randomly assigned patients to the study drug, who were at high-risk for progressing to severe COVID-19 and/or hospitalization and who met at least 1 of the high-risk criteria; Patient who reported at least 1 symptom at baseline was included) | days | MEDIAN |
| SECONDARY | Time to Clinical Recovery up to Day 14 in All Randomized Patients (Part 2) | Up to Day 14 | ITT Set (defined as all randomly assigned patients to the study drug; Patient who reported at least 1 symptom at baseline was included) | days | MEDIAN |
| SECONDARY | Proportion of Patients With Hospital Admission Due to SARS-CoV-2 Infection (Part 1 and Part 2) | Up to Day 28 | ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients Requiring Supplemental Oxygen Due to SARS-CoV-2 Infection (Part 1 and Part 2) | Up to Day 28 | ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With Mechanical Ventilation Use Due to SARS-CoV-2 Infection (Part 1 and Part 2) | Up to Day 28 | ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients Requiring Rescue Therapy Due to SARS-CoV-2 Infection (Part 1 and Part 2) | Up to Day 28 | ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With Intensive Care Unit Transfer Due to SARS-CoV-2 Infection (Part 1 and Part 2) | Up to Day 28 | ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients With All-cause Mortality (Part 1 and Part 2) | Up to Day 28 | ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR (Part 1 and Part 2) | Up to Day 28 | ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug; Patient who had positive result confirmed based on the negative threshold at baseline was included) | days | MEDIAN |
| SECONDARY | Proportion of Patient With Negative Conversion in Nasopharyngeal Swab Specimen Based on RT-qPCR at Each Visit (Part 1 and Part 2) | Days 3, 7, 10, 14, 21, and 28 | ITTI Set for Part 1 (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result \[Day 1\] of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included) and ITT Set for Part 2 (defined as all randomly assigned patients to study drug; Patient who had positive result confirmed based on the negative threshold at baseline was included) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Clinical Recovery (Part 1 and Part 2) | Up to Day 28 | ITTI Set for Part 1 (all randomly assigned patients with confirmed SARS-CoV-2 infection by Day 1 of RT-qPCR and who received a complete or partial dose of the study drug; Patient who had confirmed negative or missing at Day 1 and positive at Day 2 was also included; Patients who had absent for all symptoms or at least one missing at baseline are excluded), and ITT Set for Part 2 (all randomly assigned patients to study drug; Patient who reported at least 1 symptom at baseline was included) | days | MEDIAN |
| OTHER_PRE_SPECIFIED | [Virology] Viral Serology for SARS-CoV-2 Antibody | Days 1, 7, 14, 28, and 56 | ITTI Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion result (Day 1) of RT-qPCR, who receive a complete or partial dose of study drug) for both Parts. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | [PK] Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) (Part 1) | Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion | PK Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion \[Day 1\] result based on RT-qPCR and who had signed informed consent to participate in a PK sub-study, received a complete dose of study drug, and had at least 1 evaluable post-treatment PK result; If the pre-infusion result at Day 1 was confirmed negative or missing and the Day 2 result was confirmed positive, this patient was also included) | h*μg/mL | MEAN |
| OTHER_PRE_SPECIFIED | [PK] Maximum Serum Concentration (Cmax) (Part 1) | Pre-dose, end of infusion, 1, 24, 48, 96, 144, 216, 312, 648, 1320, 2136 hours after start of infusion | PK Set (defined as all randomly assigned patients with confirmed SARS-CoV-2 infection by pre-infusion (Day 1) result based on RT-qPCR and who had signed informed consent to participate in a PK sub-study, received a complete dose of study drug, and had at least 1 evaluable post-treatment PK result) | μg/mL | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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