|drug2900||SARS-CoV2 Infection Wiki||1.00|
There is one clinical trial.
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate the safety and tolerability of ABBV-47D11 in participants hospitalized with COVID-19 infection. In addition, this study will evaluate the pharmacokinetics (how the body handles the study drug) and anti-viral activity of the study drug. ABBV-47D11 is an investigational anti-SARS-CoV-2 monoclonal antibody being developed for the treatment of COVID-19. Participants will receive either placebo or ABBV-47D11. There is a 1 in 4 chance that participants will be assigned to placebo. Around 32 adult participants hospitalized for a diagnosis of COVID-19 will be enrolled in approximately 10 to 30 sites globally. Participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, nasal swabs and presence of side effects.
Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug.Measure: Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs) Time: Up to Day 106
Description: Participants will be assessed for the infusion-related reaction considered drug-related by the investigator.Measure: Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions Time: Up to Day 106
Description: Maximum observed serum concentration (Cmax) of ABBV-47D11.Measure: Maximum Observed Serum Concentration (Cmax) of ABBV-47D11 Time: Up to Day 85
Description: Time to maximum serum concentration of ABBV-47D11.Measure: Time to Cmax (Tmax) of ABBV-47D11 Time: Up to Day 85
Description: Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11.Measure: Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11 Time: Up to Day 29
Description: Terminal phase elimination half-life (t1/2) of ABBV-47D11.Measure: Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11 Time: Up to Day 85
Description: AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11.Measure: AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11 Time: Up to Day 85
Description: Anti-drug antibodies will be detected using a tiered approach.Measure: Detection of Anti-Drug Antibodies (ADA) Time: Up to Day 85
Description: Neutralizing anti-drug antibodies will be detected using a tiered approach.Measure: Detection of Neutralizing Anti-Drug Antibodies (nADA) Time: Up to Day 85
Description: Area Under the Serum Concentration-Time Curve (AUC) of SARS-CoV-2 RNA.Measure: AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Time: Baseline (Day 1) through Day 29
Description: Number of days from Baseline (Day 1) to negative SARS-CoV-2 by RT-PCR.Measure: Time to Negative SARS-CoV-2 by RT-PCR Time: Up to Day 29
Description: Number of participants with negative SARS-CoV-2 RNA by RT-PCR.Measure: Negative SARS-CoV-2 RNA by RT-PCR Time: Up to Day 15
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports