Publications by authors named "Romana Hosain"
Background: We evaluated the safety of SCB-2019, a protein subunit vaccine candidate containing a recombinant SARS-CoV-2 spike (S) trimer fusion protein, combined with CpG-1018/alum adjuvants.
Methods: This ongoing phase 2/3, double-blind, placebo-controlled, randomized trial is being conducted in Belgium, Brazil, Colombia, the Philippines, and South Africa in participants ≥ 12 years of age. Participants were randomly assigned to receive 2 doses of SCB-2019 or placebo administered intramuscularly 21 days apart.
Background: The open-label RECOVERY study reported improved survival in hospitalized, SARS-CoV-2 seronegative patients treated with casirivimab and imdevimab (CAS + IMD).
Methods: In this phase 1/2/3, double-blind, placebo-controlled trial conducted prior to widespread circulation of Delta and Omicron, hospitalized COVID-19 patients were randomized (1:1:1) to 2.4 g or 8.
Background: Open-label platform trials and a prospective meta-analysis suggest efficacy of anti-interleukin (IL)-6R therapies in hospitalized patients with coronavirus disease 2019 (COVID-19) receiving corticosteroids. This study evaluated the efficacy and safety of sarilumab, an anti-IL-6R monoclonal antibody, in the treatment of hospitalized patients with COVID-19.
Methods: In this adaptive, phase 2/3, randomized, double-blind, placebo-controlled trial, adults hospitalized with COVID-19 received intravenous sarilumab 400 mg or placebo.
Article Synopsis
- The study evaluated the safety and efficacy of the SCB-2019 COVID-19 vaccine in a large, double-blind, placebo-controlled trial involving over 30,000 adults across five countries.* -
- Participants were randomly assigned to receive either the vaccine or a placebo, and the primary focus was on measuring vaccine effectiveness against COVID-19 and monitoring adverse effects.* -
- Results showed that the vaccine had an overall efficacy of 67.2% against any severity of COVID-19, and 83.7% efficacy against moderate-to-severe cases, indicating its potential effectiveness in preventing the disease.*
Article Synopsis
- In the REGEN-COV adaptive trial, a combination of monoclonal antibodies significantly reduced both viral load and hospital visits in COVID-19 patients compared to a placebo.
- In the phase 3 trial, outpatients with COVID-19 received either REGEN-COV or placebo, leading to a substantial decrease in hospitalization or death rates (1.3% in the 2400-mg group vs. 4.6% in placebo).
- The treatment also expedited symptom resolution by an average of 4 days and effectively reduced viral load more rapidly than the placebo across various patient subgroups.
Background: Recent data suggest that complications and death from coronavirus disease 2019 (Covid-19) may be related to high viral loads.
Methods: In this ongoing, double-blind, phase 1-3 trial involving nonhospitalized patients with Covid-19, we investigated two fully human, neutralizing monoclonal antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, used in a combined cocktail (REGN-COV2) to reduce the risk of the emergence of treatment-resistant mutant virus. Patients were randomly assigned (1:1:1) to receive placebo, 2.
Introduction: The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and VigiBase are two established databases for safety monitoring of medicinal products, recently complemented with the EudraVigilance Data Analysis System (EVDAS).
Objective: Signals of disproportionate reporting (SDRs) can characterize the reporting profile of a drug, accounting for the distribution of all drugs and all events in the database. This study aims to quantify the redundancy among the three databases when characterized by two disproportionality-based analyses (DPA).
Background: REGN3470-3471-3479 is a co-formulated cocktail of three human monoclonal antibodies targeting three non-overlapping epitopes on Ebola virus. We investigated safety, tolerability, pharmacokinetics, and anti-drug antibodies in healthy adults.
Methods: This randomised, double-blind, placebo-controlled, dose-escalation study was done at a phase 1 unit in the USA.