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Results 521 - 525 of 525

A Phase III double-blind study to assess safety and
efficacy of an RSV Maternal unadjuvanted vaccine,
in pregnant women and infants born to vaccinated
mothers

Recruitment Status
Pending
Project Status
Ongoing
Project Description
GSK is developing an investigational Respiratory Syncytial Virus (RSV) vaccine foradministration to pregnant women, with the aim of preventing medically assessed, RSV-associatedlower respiratory tract illnesses (LRTIs) in their infants by transfer of maternalantibodies. The vacc . . .
Primary Sponsor
GlaxoSmithKline Philippines, Inc.
Study Type
Interventional
Date of Registration
15 February 2021
Date of FIrst Enrollment
05 April 2021
Region
NCR
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Single
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2020-CT0584
Sources of Monetary or Material Support
GlaxoSmithKline Biologicals
Primary Outcomes
From birth (Visit 1-NB) to 6 months (Visit 4-NB), occurrencesof medically assessed, RSV-associated severe (includingvery severe) LRTIs according to the case definitions. or From birth (Visit 1-NB) to 6 months (Visit 4-NB), occurrencesof any medically assessed, RS . . .
Key Inclusion and Exclusion Criteria
Maternal participants must satisfy all the following criteria at study entry:• Participants who, in the opinion of the investigator, can and will comply with therequirements of the protocol (e.g. completion of diaries, return for follow-up visits).• Participants who give wri . . .
Countries of Recruitment
Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Finland, France, India, Italy, Mexico, New Zealand, Panama, Philippines, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, United States
Health Condition(s) or Problem(s) Studied

Respiratory Syncytial Virus (RSV)-associated Lower Respiratory Tract Illness (LRTI)


A Phase II Study of M5049 in COVID-19 Pneumonia (ANEMONE)

Recruitment Status
Pending
Project Status
Ongoing
Project Description
In this study, M5049 taken for 14 days will be evaluated in participants who are hospitalized with moderate to severe COVID-19 pneumonia but not on mechanical ventilation. The exploratory Phase II study will evaluate if M5049 inhibition of the host inflammatory response targets, a potential mecha . . .
Primary Sponsor
Merck Healthcare KGaA
Secondary Sponsor
IQVIA RDS Philippines, Inc.
Study Type
Interventional
Date of Registration
19 February 2021
Date of FIrst Enrollment
26 February 2021
Region
Germany
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2020-CT0580
Sources of Monetary or Material Support
Merck Healthcare KGaA
Primary Outcomes

To assess the safety of M5049 compared to placebo.

To assess the proportion of participants free of respiratory support in M5049 compared to placebo participants.

To assess the safety of M5049 compared to placebo.

Key Inclusion and Exclusion Criteria
Inclusion Criteria Participants are eligible to be included in the study only if all the following criteria apply during the 48-hour study Screening Period: Informed Consent: 1. Participant (or legally authorized representative) provides signed informed consent prior to the initi . . .
Health Condition(s) or Problem(s) Studied

COVID 19 Pneumonia treatment


A Phase 3 Study to Evaluate Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined with AB154 in Front-Line, PD-L1-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Recruitment Status
Pending
Project Status
Ongoing
Project Description
This is a Phase 3, multicenter, 3-arm randomized, open-label study in male and female participants at least 18 years of age (or local legal age) with ≥ 1 measurable lesion(s) per RECIST v1.1, a diagnosis of locally advanced or metastatic (Stage IIIB - IV per AJCC version 8) squamous or non-squa . . .
Primary Sponsor
Arcus Biosciences, Inc.
Secondary Sponsor
Novotech (Australia) Pty. Ltd. - Philippine Branch
Study Type
Interventional
Date of Registration
22 February 2021
Date of FIrst Enrollment
01 June 2021
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Not Applicable
Phase
Phase III
FDA Clinical Trial Reference (CTR) Number
2021-CT0589
Sources of Monetary or Material Support
Arcus Biosciences, Inc.
Primary Outcomes
Efficacy Objective(s) • To evaluate the efficacy of zimberelimab monotherapy compared to platinum-doublet chemotherapy (Arm A vs. Arm B) • To evaluate the efficacy of zimberelimab and domvanalimab combination therapy compared to zimberelimab monotherapy (Arm B vs. Arm C) . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria 1. Male or female participants; age ≥ 18 years, or age ≥ regionally approved age of consent for participation in investigational clinical studies, at the time of prescreening. 2. Willing and able to comply with the requirements and restrictions in this proto . . .
Countries of Recruitment
Argentina, Austria, Bangladesh, Belarus, Bosnia and Herzegovina, Brazil, Chile, Colombia, Cuba, Egypt, Finland, Hong Kong, India, Jordan, Malaysia, Mexico, Norway, Peru, Philippines, Puerto Rico, Russia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, Vietnam
Health Condition(s) or Problem(s) Studied

PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer


A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects with Moderate COVID-19

Recruitment Status
Pending
Project Status
Ongoing
Project Description
Adult subjects, ≥18 years of age, who are hospitalized/confined with moderate COVID-19 and not on a ventilator.  Subjects must be diagnosed with COVID-19 (SARS-CoV-2 positive) by a standard assay or equivalent testing.  Note: SARS-CoV-2 infection will be confirmed at Screening and assesse . . .
Primary Sponsor
ATEA Pharmaceuticals, Inc.
Secondary Sponsor
IQVIA RDS Philippines, Inc.
Study Type
Interventional
Date of Registration
22 February 2021
Date of FIrst Enrollment
15 March 2021
Region
United States of America
Method of Allocation
Randomized
Masking
Double Blind
Assignment
Parallel
Phase
Phase II
FDA Clinical Trial Reference (CTR) Number
2020-CT0579
Sources of Monetary or Material Support
ATEA Pharmaceuticals, Inc.
Primary Outcomes
 The primary efficacy endpoint is PRI, defined as a ≥ 2-tier increase in respiratory support methods required to maintain satisfactory oxygenation (SpO2 ≥ 93%), using a 6-tier hierarchical scale of respiratory support methods, within the 14-day study period. The primary efficacy goal is a . . .
Key Inclusion and Exclusion Criteria
Inclusion Criteria: 1. Willing and able to provide informed consent. 2. Male or female subjects ≥18 years of age. 3. Subject is hospitalized or in a hospital-affiliated confinement facility for which the principal investigator is credentialed and study staff have access to study participants an . . .
Countries of Recruitment
Belgium, Philippines, United States, Belarus, Bosnia and Herzegovina, Brazil, Chile, Colombia, Cuba, Egypt, Finland, Hong Kong, India, Jordan, Malaysia, Mexico, Norway, Peru, Philippines, Puerto Rico, Russia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, Vietnam
Health Condition(s) or Problem(s) Studied

Moderate COVID 19 


Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This study aims to o determine the safety and efficacy of VCO as adjunctive therapy for COVID-19 cases. Specifically, the study will determine the safety of VCO through clinical parameters such as lipid profile, fasting blood sugar, and creatinine and the efficacy of VCO through recovery from sym . . .
Primary Sponsor
University of the Philippines Manila
Secondary Sponsor
Philippine Council for Health Research and Development, Department of Science and Technology
Philippine Coconut Authority
Study Type
Interventional
Date of Registration
04 March 2021
Date of FIrst Enrollment
01 June 2020
Region
Philippines
Method of Allocation
Randomized
Masking
Open Label
Assignment
Parallel
Phase
Phase II
Sources of Monetary or Material Support
Philippine Council for Health Research and Development
Philippine Coconut Authority
University of the Philippines - Manila
Primary Outcomes

The primary outcomes of the study are as follows: 

1. duration of hospital stay
2. time to recovery/resolution of symptoms

Key Inclusion and Exclusion Criteria
The following patients will be recruited to participate in the study:1. symptomatic and asymptomatic COVID-19 hospitalized patients2. has laboratory-confirmed illness during the time of recruitment3. able to take food and medicines enterally Excl . . .
Countries of Recruitment
Philippines, Philippines, United States, Belarus, Bosnia and Herzegovina, Brazil, Chile, Colombia, Cuba, Egypt, Finland, Hong Kong, India, Jordan, Malaysia, Mexico, Norway, Peru, Philippines, Puerto Rico, Russia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, Vietnam
Health Condition(s) or Problem(s) Studied

Coronavirus Disease-2019 (COVID-19)


Results 521 - 525 of 525
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