This is a multicenter, randomized, initially blinded (masked), phase 2 trial to assess SARS-CoV-2 vaccination reactions in two populations:
- One population including individuals with a history of allergic reactions or Mast Cell Disorder (HA/MCD),and
- One allergy-free population.
Approximately 2040 High-Allergy/Mast Cell Disorder (HA/MCD) and 1360 participants without allergies will be enrolled across participating sites in the United States (3400 total participants). Approximately two-thirds of participants enrolled in each of the 2 groups will be female. This is because the vast majority of cases of anaphylaxis to the COVID-19 vaccines have occurred in women.
Study Duration: Randomized and vaccinated participants will complete study participation in approximately 29 days if vaccinated with the Pfizer-BioNTech COVID-19 Vaccine, 36 days if vaccinated with the Moderna COVID-19 Vaccine, and 50 or 64 days if administered placebo before receiving two doses of either the Pfizer-BioNTech COVID-19 Vaccine or the Moderna COVID-19 Vaccine, respectively.
Total study duration: Approximately 17 weeks.
The research objectives are to evaluate each agent with respect to speed of recovery, mortality, illness severity, and hospital resource utilization
To evaluate safety and explore clinical benefits of Silmitasertib 1000 mg BID dose in patients with severe illness caused be SARS-COV-2.
To assess the safety and efficacy of convalescent donor plasma to treat COVID-19 in hospitalized adults in a randomized, placebo-controlled setting.
To evaluate clinical efficacy of convalescent plasma compared to placebo, among adults with COVID-19 requiring hospitalization.
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
This study is randomized trial to assess the effectiveness and safety of using combination therapy drugs in treating COVID-19 patients. This study is active, but closing soon.
Objectives are to exclude futility of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation; evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo Phase 2 (Cohort 1A); evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation; evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo Phase 3 (Cohort 1 and Cohort 1A); and to evaluate the clinical efficacy of REGN10933+REGN10987 compared to placebo, as measured by death or mechanical ventilation
COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19
To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo
Performance (discrimination / calibration) of models [ Time Frame: From date of study enrollment until the date of first documented ARDS diagnosis or date of death from any cause, whichever comes first, assessed up to study end (estimated at 3 months). ] Performance (discrimination / calibration) of models that predict the risk of development of ARDS and/or mortality among COVID-19 patients who present to the hospital for evaluation and treatment.
Researchers are creating a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals.