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NCT ID: NCT04327388 Completed - Clinical trials for Corona Virus Infection

Sarilumab COVID-19

Start date: March 28, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To evaluate the clinical efficacy of sarilumab relative to the control arm in adult participants hospitalized with severe or critical Coronavirus Disease 2019 (COVID-19). Secondary Objectives: - Evaluate the 28-day survival rate. - Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity. - Evaluate changes in the National Early Warning Score 2. - Evaluate the duration of predefined symptoms and signs (if applicable). - Evaluate the duration of supplemental oxygen dependency (if applicable). - Evaluate the incidence of new mechanical ventilation use during the study. - Evaluate the duration of new mechanical ventilation use during the Study. - Evaluate the proportion of participants requiring rescue medication during the 28-day period. - Evaluate need for admission into intensive care unit. - Evaluate duration of hospitalization (days). - The secondary safety objectives of the study were to evaluate the safety of sarilumab through hospitalization (up to Day 29 if participant was still hospitalized) compared to the control arm as assessed by incidence of: - Serious adverse events. - Major or opportunistic bacterial or fungal infections in participants with grade 4 neutropenia. - Grade greater than or equal to (>=) 2 infusion related reactions. - Grade >=2 hypersensitivity reactions. - Increase in alanine transaminase (ALT) >=3X upper limit of normal (ULN) (for participants with normal baseline) or greater than 3X ULN AND at least 2-fold increase from baseline value (for participants with abnormal baseline). - Major or opportunistic bacterial or fungal infections.

NCT ID: NCT04327024 Completed - Clinical trials for Heart Failure With Preserved Ejection Fraction (HFpEF)

Study of Verinurad in Heart Failure With Preserved Ejection Fraction

AMETHYST
Start date: May 19, 2020
Phase: Phase 2
Study type: Interventional

International, Multicenter, Double-Blind, Placebo and Active Control Efficacy and Safety Study to Evaluate Verinurad combined with Allopurinol in Heart Failure with Preserved Ejection Fraction

NCT ID: NCT04325035 Active, not recruiting - Cardiogenic Shock Clinical Trials

The Safety and Efficacy of Istaroxime for Pre-Cardiogenic Shock

SEISMiC
Start date: September 28, 2020
Phase: Phase 2
Study type: Interventional

This is a pilot, multinational, randomized, double-blind, placebo-controlled, 2-part safety and efficacy study. Subjects will consist of patients hospitalized for acute decompensated heart failure with persistent hypotension.

NCT ID: NCT04320342 Recruiting - COPD Clinical Trials

A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD

TRITON
Start date: April 28, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.

NCT ID: NCT04318093 Completed - Clinical trials for Acute Decompensated Heart Failure

Study of the Safety of BMS-986259 in Participants With Post-Acute Decompensated Heart Failure

Start date: November 6, 2020
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess the safety of BMS-986259 in stable participants hospitalized for acute decompensated heart failure.

NCT ID: NCT04308681 Completed - Pulmonary Fibrosis Clinical Trials

A Study Measuring the Effectiveness, Safety, and Tolerability of BMS-986278 in Participants With Lung Fibrosis

Start date: July 29, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to provide an initial evaluation of the effectiveness of BMS-986278 in participants with lung fibrosis, to demonstrate the safety of BMS-986278, and provide information on the drug levels of BMS-986278 in these participants.

NCT ID: NCT04305496 Active, not recruiting - Clinical trials for Locally Advanced (Inoperable) or Metastatic Breast Cancer

Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer

CAPItello-291
Start date: April 16, 2020
Phase: Phase 3
Study type: Interventional

Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer following recurrence or progression on or after AI therapy.

NCT ID: NCT04305054 Recruiting - Melanoma Clinical Trials

Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)

Start date: July 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Substudy 02B is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02B is to evaluate the safety and efficacy of investigational treatment arms in participants with 1L advanced melanoma and to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/pembrolizumab monotherapy. Arm 1: Pembrolizumab + Vibostolimab was added in the base protocol on 13-Nov-2019, and enrollment into this arm has been completed. Arm 2: Pembrolizumab was added in the base protocol on 13-Nov-2019, and enrollment stopped prematurely on 15-Aug-2022. Arm 3: Coformulation Pembrolizumab/Quavonlimab was added in Amendment 01 on 20-Oct-2020, and enrollment stopped prematurely on 15-Aug-2022. Arm 4: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib was added in Amendment 01 on 20-Oct-2020, and enrollment is ongoing. Arm 5: Coformulation Favezelimab/Pembrolizumab, Arm 6: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA), and Arm 7: Coformulation Favezelimab/Pembrolizumab + Vibostolimab were added in Amendment 04 on 10-May-2023, and enrollment for these arms will be initiated in July 2023.

NCT ID: NCT04297319 Terminated - Lasers Clinical Trials

The Use of Laser in the Treatment of Atrophic Vulvovaginitis

Start date: September 20, 2019
Phase: N/A
Study type: Interventional

This study evaluates the efficacy and security of laser for atrophy treatment. Half of participants will receive the laser treatment and the other half placebo.

NCT ID: NCT04294667 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus

PHOENYCS GO
Start date: August 12, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.