Overview: This study is to evaluate the safety, tolerability and efficacy of AT-527 in older subjects (ages 45-80 years) with moderate COVID-19 and risk factors of poor outcomes (such as obesity (BMI>30), hypertension, diabetes or asthma).
Target population: Adults 45-80 years
Locations:Prisma Health–Midlands; Atea Study Site, Charleston
Further information: Clinicaltrials.gov NCT04396106; 888-481-1607, firstname.lastname@example.org
Overview: This study is to investigate whether the combination of Famotidine and N-Acetyl Cysteine can be given safely in combination at increasing dosages to adults who are newly diagnosed with SARS-Co-V-2 infection.
Target population: Adults ≥ 18 years and older
Locations: Prisma Health–Upstate (Greenville Memorial Hospital, Greer Memorial Hospital, Baptist Easley Hospital).
Further information: 864-671-3001
Overview: 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 and ABBV-2B04 given alone and in combination to participants 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 and ABBV-2B04 are investigational anti-SARS-CoV-2 monoclonal antibodies being developed for the treatment of COVID-19. Study will be conducted in two parts. In part A, participants will receive ABBV-47D11 or placebo. There is a 1 in 4 chance that participants will be assigned to placebo. In part B, participants will receive ABBV-2B04 alone or in combination with ABBV-47D11 or placebo. There is a 1 in 5 chance that participants will be assigned to placebo. Around 54 adult participants with COVID-19 will be enrolled in approximately 10 to 30 sites globally.
In part A, participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo on Day 1. In part B, participants will receive single intravenous (into the veins) infusion of ABBV-2B04 alone or in combination with ABBV-47D11 or placebo on Day 1. Participants will be followed up for 106 days.
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.
Target Population: Adults ≥ 18 years and older
Locations: Prisma Health–Upstate
Further Information: Clinicaltrials.gov NCT04644120; Abbvie Call Center, 844-663-3742, email@example.com